Description
As of January 31, 2018, over-the-counter denture repair kits (Product Code EBO, 21 CFR 872.3570) are exempt from premarket notification (510(k)). Please refer to the Federal Register of March 14, 2018 (Docket No. FDA-2017-P-5124) for more information.
Scope & Applicability
Product Classes
8exempt from premarket notification (510(k))
subject of the guidance document
subject of the guidance document
subject of the guidance document
Class I or Class III device depending on material
Device intended to replace a worn denture lining
Device intended to repair cracks or breaks in dentures
Prescription device composed of preformed teeth
Stakeholders
4Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Branch Chief and primary contact for dental device guidance questions
Specific branch (HFZ-480) within the Office of Device Evaluation
Entity providing guidance documents upon request
Identified Hazards
Hazards
1Potential risk from long term use of OTC denture products
Related CFR Sections (7)
- 21CFR872.3570§ 872.3570 OTC denture repair kit.
(a) Identification. An OTC denture repair kit is a device consisting of a material, such as a resin monomer system of powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter.Read full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR872.3540§ 872.3540 OTC denture cushion or pad.
(a) Identification. An OTC denture cushion or pad is a prefabricated or noncustom made disposable device that is intended to improve the fit of a loose or uncomfortable denture, and may be available for purchase over-the-counter.Read full regulation →
- 21CFR872.3560§ 872.3560 OTC denture reliner.
(a) Identification. An OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture. The device is intended to replace a worn denture lining and may be available foRead full regulation →
- 21CFR872.3600§ 872.3600 Partially fabricated denture kit.
(a) Identification. A partially fabricated denture kit is a device composed of connected preformed teeth that is intended for use in construction of a denture. A denture base is constructed using the patient's mouth as a mold, by partially polymerizing the resin denture base materials while the mateRead full regulation →
- 21CFR801.405§ 801.405 Labeling of articles intended for lay use in the repairing and/or refitting of dentures.
(a) The American Dental Association and leading dental authorities have advised the Food and Drug Administration of their concern regarding the safety of denture reliners, repair kits, pads, cushions, and other articles marketed and labeled for lay use in the repairing, refitting, or cushioning of iRead full regulation →
- 21CFR807.97§ 807.97 Misbranding by reference to premarket notification.
Submission of a premarket notification in accordance with this subpart, and a subsequent determination by the Commissioner that the device intended for introduction into commercial distribution is substantially equivalent to a device in commercial distribution before May 28, 1976, or is substantiallRead full regulation →
See Also (8)
- Product Labeling for Laparoscopic Power Morcellators: Guidance for Industry and Food and Drug Administration Staff
- Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
- Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff
- Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
- Minimizing Risk for Children's Toy Laser Products: Guidance for Industry and Food and Drug Administration Staff
- Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards
- Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff