ORAFIX SPECIAL DENTURE ADHESIVE
FDA 510(k) clearance K943486 · decided 1994-11-03
Clearance details
- K-number
- K943486
- Device name
- ORAFIX SPECIAL DENTURE ADHESIVE
- Applicant
- Smithkline Beecham Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-19
- Decision date
- 1994-11-03
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- KOO
- Device class
- 1
- Regulation number
- 872.3490
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES (K945200) | Procter & Gamble Co. | 1994-11-30 |
| PROFAST - DENTURE ADHESIVE FOR LOWER JAWS (K930335) | Fittydent-Altwirth & Schmitt GmbH | 1994-02-01 |
| NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM (K862876) | Block Drug Company, Inc. | 1986-08-29 |
Recalls involving this device
No recalls on record reference this clearance.