513(g) Request Content for a Dental Device Without a Predicate

What to include in a 513(g) request for an early-stage dental device with no clear predicate

Bottom line

A 513(g) Request for Information is the statutory mechanism to ask FDA for its view on the class into which a device falls and the regulatory requirements that apply to it ⁴¹⁴³. It is an information request, not a marketing pathway. For an early-stage dental device with no obvious predicate, a well-built 513(g) gives you FDA's read on the likely generic type, class, and whether a 510(k), De Novo, PMA, or nothing is required ⁴¹. What it will not give you is a formal classification decision, a substantial-equivalence determination, or advice on the specific testing needed to support a future marketing submission. For those, FDA points you to the Q-Submission (Pre-Sub) program ⁴¹³⁸.

What a 513(g) request must and should contain

FDA recommends identifying the submission clearly as a "513(g) Request for Information" and submitting it as an eCopy, through the voluntary eSTAR template for 513(g)s, or as one complete paper copy; CDRH submissions can go through the CDRH Portal or the Document Control Center ⁴⁹. The core contents are modest compared with a marketing submission ⁴³:

Signed cover letter. The cover letter should identify the submission as a 513(g) Request for Information and include the date of the request, the device name, the specific question(s) about the class in which the device has been classified and/or the regulatory requirements applicable to it, the requestor's name, address, telephone, fax, and email, and the requestor's signature ⁴³⁴⁶. If no proposed labeling exists for the device or a similar legally marketed device, note that in the cover letter ⁴⁴.

Device description. FDA recommends including a list of materials and components used in or with the device, photographs, engineering drawings, and/or samples, a summary of operational principles (for example, whether it contains software or firmware), a description of the type and amount of energy used or delivered, and a description of similar devices in U.S. commercial distribution if available ⁴³⁴⁶.

Intended-use information. Describe what the device is used for ⁴³, including the disease or condition addressed, prescription versus over-the-counter use, the part of the body or type of tissue contacted, frequency of use, physiological purpose, patient population, and environment of use ⁴⁶.

Labeling. Include any proposed labeling or promotional material for the device and, as applicable, labeling or promotional material for a similar, legally marketed device if available ⁴³.

Specific questions. The request should pose the specific classification and/or applicable-requirements questions you want answered ⁴⁶. FDA advises that a single 513(g) request should seek information for a single product; multiple products should be split into separate requests, each carrying its own user fee ⁴³.

One point worth flagging for teams that draft 513(g)s like a 510(k): the guidance does not require you to state a proposed classification regulation or product code. FDA's response is where it generally identifies the generic type, the class, and the applicable submission type if the product appears to be a device ⁴¹⁴⁴. You may of course frame your questions around a suspected classification, but the burden is not to prove a classification the way a De Novo or 510(k) would.

The user fee and administrative mechanics

FDA is required to collect a user fee for a 513(g) request, and it may not accept the request for review until all fees owed, including any required establishment registration fees, are paid ⁴³. FDA Form 3601 (Medical Device User Fee Cover Sheet) is required ⁵⁷. If the submission turns out not to be a genuine 513(g) request, FDA intends to refund any user fee submitted with it ⁴³⁵⁰. If FDA later asks you for additional information to complete the review, no additional user fee is due for that response ⁵⁷; but a subsequent 510(k), De Novo, or PMA carries its own applicable fee ⁵⁷.

On timing and completeness: FDA intends to respond within 60 days of receipt, once the submission and all fees owed have been received, in the form of a confidential letter to the manufacturer ⁴⁴⁶⁸⁴³. If the submission is incomplete, FDA will contact the submitter for more information; if no response is received within 30 days, FDA may consider the request withdrawn and may issue a withdrawal notice ⁴⁸.

What FDA's 513(g) response will and will not do

FDA's written response is based solely on the information you submit ⁴¹. If the product does not appear to be a device under section 201(h), FDA will say so ⁴¹. If it does appear to be a device, FDA will generally provide ⁴¹:

• its assessment of the generic type of device (for example, the classification regulation) the product appears to fall within;
• the class within that generic type;
• whether a PMA, a 510(k), or neither is required to market the device;
• other applicable FDA requirements, including whether an enforcement-discretion guidance exists, and whether additional requirements apply (for example, requirements for radiation-emitting products).

Just as important are the limits ⁴¹:

• FDA does not review data related to substantial equivalence or safety and effectiveness in a 513(g).
• The response is not a device classification decision and does not constitute clearance or approval for marketing.
• It does not address the specific nonclinical, animal, or clinical testing needed to support a future marketing application.
• A 513(g) response does not constitute final Agency action ⁴⁹.

Why the "no clear predicate" fact matters, and where 513(g) fits

For a device with no legally marketed predicate, the classification answer FDA gives in a 513(g) shapes your entire strategy. A device is eligible for 510(k) only when a manufacturer can show the same intended use as a legally marketed predicate and either the same technological characteristics or differences that do not raise different questions of safety and effectiveness ^859496100. When no predicate with the same intended use can be identified, the device may need De Novo classification, and high-risk devices may require PMA ⁹³.

The De Novo pathway exists precisely for a novel device with no predicate: it lets FDA classify a device into class I or class II when general controls, or general plus special controls, provide a reasonable assurance of safety and effectiveness ⁵¹. It is also the route for devices that are automatically (statutorily) class III only because FDA has not previously classified that device type ². Note that FDA may decline a De Novo request if it later identifies a predicate that could support a substantial-equivalence review ⁴. A De Novo request itself must include a description of the device and detailed information and reasons for the recommended classification, demonstrating that general controls (or general plus special controls) are sufficient ¹⁶.

This is why sequencing matters. A 513(g) is a low-burden way to get FDA's classification read first. If FDA's letter indicates there is no predicate and the device is low-to-moderate risk, that supports planning a De Novo. But because the 513(g) response explicitly will not tell you what testing a De Novo or 510(k) will need ⁴¹, most sponsors of genuinely novel devices pair or follow the 513(g) with a Pre-Submission.

513(g) versus the Pre-Submission (Q-Sub): choosing the right tool

The two mechanisms answer different questions ³⁸:

Dimension	513(g) Request for Information	Pre-Submission (Q-Sub)
Core purpose	Obtain FDA's information on the class a device is in and the requirements applicable to it under the FD&C Act 3841	Obtain FDA feedback on planned regulatory strategy and development questions before a marketing submission 2238
Classification	FDA identifies apparent generic type, class, and required submission type 41	Regulatory pathway may be discussed, but classification is not determined via Pre-Sub 38
Testing advice	Not addressed 41	Appropriate venue for specific questions on biocompatibility, bench testing, cybersecurity, etc. 2236
User fee	Required; Form 3601 4357	No MDUFA user fee
FDA response	Confidential letter, target 60 days 4468	Written feedback only, or written feedback plus a meeting 22
Format	eCopy / eSTAR / paper; cover letter with specific questions 4946	Q-Sub cover elements plus focused, specific questions; draft agenda and preferred dates if a meeting is requested 2634

FDA is explicit that classification and assignment information should not be solicited through a Pre-Sub, and, conversely, that a 513(g) is the mechanism for classification/status information under section 513 ³⁸. A Pre-Sub is a formal written request for feedback and is not intended to be a pre-review of an intended submission or its data ²²²². If your product is a combination product, identify it as such in the cover letter and, if appropriate, send a copy to the Office of Combination Products ²⁰³⁹.

Practical read for an early-stage dental device with no predicate: use the 513(g) to lock in FDA's view of class and pathway, then use a Pre-Sub to negotiate the evidence package (bench, biocompatibility per the relevant material-contact profile, and any clinical need) for the De Novo or 510(k) that follows.

Dental-specific context to build into the request

Grounding the device description and questions in the FDA dental classification landscape strengthens the 513(g). Under the Dental (DE) medical specialty panel, device types cluster in class I and class II under 21 CFR Part 872 ¹⁰⁹¹¹⁵. Representative examples from the classification database include ^{109110111112115122129132}:

Product code	Device type	Class	Regulation
DZP	Instrument, Diamond, Dental	1	872.4535 109
DZM	Needle, Dental	1	872.4730 110
DZN	Instruments, Dental Hand	1	872.4565 111
DZA	Drill, Dental, Intraoral	1	872.4130 112
QRY	Dental Navigation System	2	872.4120 115
PLV	Dental Stereotaxic Instrument	2	872.4120 122
SBC	Dental Image Analyzer	2	872.1770 129
SHQ	Dental Image Analyzer, In-Office	2	872.1770 132

Because the classification records tie each product code to an intended use, materials/tissue contact, and operating principle, mirroring those same descriptors in your 513(g) device description and intended-use section helps FDA map your device to the closest generic type, or confirm that none fits. For a dental device, be specific about the tissue contacted (for example, intact oral mucosa, dentin, pulp, or bone), the duration and nature of contact, energy delivered, and whether software is involved, since those drive both the classification regulation and the eventual biocompatibility and performance expectations ⁴⁶⁸⁹.

A practical drafting checklist

1. Header and cover letter labeled "513(g) Request for Information," with date, device name, requestor contact details, and signature ⁴³⁴⁶.
2. One product per request; separate requests and fees for distinct products ⁴³.
3. Device description: materials/components, photos or drawings, operational principles (including software/firmware), energy delivered, and similar U.S.-marketed devices if any ⁴⁶.
4. Intended-use section: condition treated, Rx vs. OTC, tissue/body-part contact, frequency, physiological purpose, patient population, environment of use ⁴⁶.
5. Proposed or comparator labeling, or a note that none is available ⁴³⁴⁴.
6. Specific, answerable questions on class and applicable requirements, framed against the Part 872 dental landscape ⁴⁶.
7. Form 3601 and payment of the 513(g) user fee (and any owed registration fees) before submission ⁴³⁵⁷.
8. Plan the follow-on Pre-Sub for testing and evidence questions, since the 513(g) response will not cover them ⁴¹³⁸.

Limitations of this overview

This summary reflects the current FDA guidance texts retrieved for this analysis and the dental classification records available in the product classification database; it is not legal advice and does not substitute for reading the full 513(g) guidance ⁴¹ and confirming current MDUFA fee amounts and submission logistics on FDA's website. The dental classification examples are illustrative of the DE panel and were not exhaustive; no class III dental device appeared in the retrieved sample, but that does not establish that none exists ^109115129. For device-specific questions (for example, the exact biocompatibility endpoints for your material-contact profile, or whether a specific predicate exists), a targeted Pre-Sub and a fresh classification-database search keyed to your intended use are the logical next steps.