510(k) K945200
K945200 is an FDA 510(k) premarket notification submitted by Procter & Gamble Co. for the device "FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES". The FDA issued a decision of Substantially Equivalent on November 30, 1994. The device falls under product code KOO (Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt), a Class I device regulated under 21 CFR 872.3490. Procter & Gamble Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1994
- Date Received
- October 25, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
- Device Class
- Class I
- Regulation Number
- 872.3490
- Review Panel
- DE
- Submission Type