510(k) K871980
K871980 is an FDA 510(k) premarket notification submitted by Solar Dental Co., Inc. for the device "D-23 DENTURE ADHESIVE". The FDA issued a decision of Substantially Equivalent on June 5, 1987. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Solar Dental Co., Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 1987
- Date Received
- May 22, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Airbrush
- Device Class
- Class II
- Regulation Number
- 872.6080
- Review Panel
- DE
- Submission Type