Reliner, Denture, Over The Counter
The Over-the-Counter Denture Reliner is a dental device sold directly to consumers that is applied to the tissue-bearing surface of an existing full or partial denture to improve its fit and comfort without requiring professional dental services. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EBP and the applicable regulation is 21 CFR 872.3560, under the Dental medical specialty.
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Basic Information
- Product Code
- EBP
- Device Class
- FDA class 2
- Regulation Number
- 872.3560
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.