Product Code: EHS
FDA class 2
21 CFR 872.3540
Cushion, Denture, Over The Counter
Dental
The Over-The-Counter Denture Cushion is a soft, pliable consumer product placed between a removable denture and the gum tissue to improve the fit and comfort of ill-fitting dentures without professional relining. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is EHS, regulated under 21 CFR 872.3540 in the Dental (DE) specialty.
510(k)s
3
FEI Numbers
2
Registration Numbers
2
Unique Applicants
3
Years Active
20
Basic Information
- Product Code
- EHS
- Device Class
- FDA class 2
- Regulation Number
- 872.3540
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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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 |
|---|---|---|---|---|
| K971002 | SMILE WITH CONFIDENCE | Jul 15, 1997 | Substantially Equivalent | LLOYD V. ZIEMENDORF |
| K813190 | SOFT PLATE CUSHION | Feb 05, 1982 | Substantially Equivalent | LEONARD RUSSO CO. |
| K770413 | CUSHIONS, DENTURE ADHESIVE, ALL-DAY | Jun 24, 1977 | Substantially Equivalent | COMBE, INC. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.