FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES
FDA 510(k) clearance K945200 · decided 1994-11-30
Clearance details
- K-number
- K945200
- Device name
- FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES
- Applicant
- Procter & Gamble Co.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-25
- Decision date
- 1994-11-30
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- KOO
- Device class
- 1
- Regulation number
- 872.3490
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Cincinnati, OH, 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 |
|---|---|---|
| ORAFIX SPECIAL DENTURE ADHESIVE (K943486) | Smithkline Beecham Corp. | 1994-11-03 |
| 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
| Record | Firm | Date |
|---|---|---|
| FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODEN recall (Z-0263-2024) | Family Dollar Stores, Llc. | 2023-11-07 |
| FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239 recall (Z-1538-2022) | Family Dollar Stores, Llc. | 2022-08-17 |