Coating, Denture Hydrophilic, Resin
The Hydrophilic Resin Denture Coating is a dental material applied to the surface of a denture base to improve its wettability and tissue compatibility, reducing the accumulation of plaque and improving patient comfort. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EBE and the applicable regulation is 21 CFR 872.3300, under the Dental medical specialty.
Basic Information
- Product Code
- EBE
- Device Class
- FDA class 2
- Regulation Number
- 872.3300
- 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.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K832500 | CS-11 | Oct 27, 1983 | Substantially Equivalent | CHEMA-SCUTUM, INC. |
| K830491 | JOHNSON & JOHNSON OPAQUE COLOR MODIFI | Mar 17, 1983 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K790339 | CONCEPT II | Jul 17, 1979 | Substantially Equivalent | RICHARDSON MERREL, INC. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.