FDA PRODUCT CODE · CLASS III
MMT — Resin, Root Canal Filling Containing Chloroform
What these counts are not
Clearance and recall counts are SPEQ’s aggregation of FDA’s own published records for the code. A recall count is a measure of history, not of a device’s safety, neither number is an FDA rating, and SPEQ is not affiliated with the FDA.
What this classification requires
Every statement below is FDA’s own classification record for this product code, quoted from the device classification field reference. The SPEQ reading beneath each one is SPEQ’s interpretation of what it means for the work, and is not FDA text.
PMA
SPEQ READINGPremarket approval under 21 CFR Part 814. FDA reviews safety and effectiveness directly rather than by comparison, so clinical evidence is normally expected and the quality system is inspected before approval rather than after marketing.
Class III (high risk): general controls and Premarket Approval (PMA)
SPEQ READINGGeneral controls are insufficient to assure safety and effectiveness, so approval rests on direct evidence rather than equivalence.
Device is eligible for The Voluntary Malfunction Summary Reporting Program
SPEQ READINGMalfunctions for this code may be reported in periodic summary form rather than as individual MDRs under 21 CFR Part 803. Eligibility is a property of the product code; using it is a decision the manufacturer makes and must be able to justify.
Not exempt due to Good Manufacturing Practice (GMP)/Quality System
SPEQ READINGThe full Quality Management System Regulation (21 CFR 820, incorporating ISO 13485:2016) applies, and is what an FDA inspection of this device will be conducted against.
Device is not implantable
SPEQ READINGNo implant-specific expectations attach from the classification itself.
Device is not used for life sustaining purposes
SPEQ READINGNo life-sustaining designation attaches to this code.
Device is not a candidate for a third party review program
SPEQ READINGFDA reviews any premarket notification for this code directly.
Other product codes under 21 CFR 872.3820
One regulation usually governs several product codes. These share this code’s regulation, and therefore its classification basis.
21 CFR 872.3820 — Root canal filling resin
The classification regulation for this product code, as published by the Office of the Federal Register. This is the regulation text itself — no SPEQ interpretation appears in it.
(a) Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.
(b) Classification.
(1) Class II if chloroform is not used as an ingredient in the device.
(2) Class III if chloroform is used as an ingredient in the device.
(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996]
Source: Electronic Code of Federal Regulations, Title 21. 21 CFR is a work of the United States Government and is in the public domain. SPEQ read this section on October 22, 2026. CFR is amended continuously, so verify against the source before acting on it: read 21 CFR 872.3820 on eCFR →
Source: FDA device classification, 510(k)/PMA, and recall datasets. Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. Browse every product code SPEQ tracks →