510(k) K871980

D-23 DENTURE ADHESIVE by Solar Dental Co., Inc. — Product Code KOJ

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