510(k) K930335
K930335 is an FDA 510(k) premarket notification submitted by Fittydent-Altwirth & Schmitt GmbH for the device "PROFAST - DENTURE ADHESIVE FOR LOWER JAWS". The FDA issued a decision of Substantially Equivalent on February 1, 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. Fittydent-Altwirth & Schmitt GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1994
- Date Received
- January 22, 1993
- 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