510(k) K991099

AMERICAN DENTAL PRODUCTS ETCH-DETECT by American Dental Products, Inc. — Product Code EBC

K991099 is an FDA 510(k) premarket notification submitted by American Dental Products, Inc. for the device "AMERICAN DENTAL PRODUCTS ETCH-DETECT". The FDA issued a decision of Substantially Equivalent on June 10, 1999. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. American Dental Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1999
Date Received
April 1, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sealant, Pit And Fissure, And Conditioner
Device Class
Class II
Regulation Number
872.3765
Review Panel
DE
Submission Type