Product Code: KOP
FDA class 1
21 CFR 872.3450
Adhesive, Denture, Karaya
Dental
This device is a denture adhesive made from karaya, a natural plant-based gum, used to improve the fit and retention of removable dentures. It is classified as FDA Class 1, indicating low risk and regulation through general controls only, without requiring premarket notification or approval. The product code is KOP, and it falls under 21 CFR 872.3450 in the Dental specialty. No special flags apply to this device.
510(k)s
1
FEI Numbers
4
Registration Numbers
4
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- KOP
- Device Class
- FDA class 1
- Regulation Number
- 872.3450
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K802285 | OHIO THORACIC SUCTION REGULATOR | Oct 03, 1980 | Substantially Equivalent | OHIO MEDICAL PRODUCTS |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.