510(k) K910216
K910216 is an FDA 510(k) premarket notification submitted by Stiefel Research Institute, Inc. for the device "STEADFAST DENTURE ADHESIVE POWDER". The FDA issued a decision of Substantially Equivalent on March 29, 1991. The device falls under product code KOM (Adhesive, Denture, Acacia And Karaya With Sodium Borate), a Class I device regulated under 21 CFR 872.3400. Stiefel Research Institute, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 1991
- Date Received
- January 17, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adhesive, Denture, Acacia And Karaya With Sodium Borate
- Device Class
- Class I
- Regulation Number
- 872.3400
- Review Panel
- DE
- Submission Type