510(k) K954223

AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING by American Dental Products, Inc. — Product Code ELW

K954223 is an FDA 510(k) premarket notification submitted by American Dental Products, Inc. for the device "AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING". The FDA issued a decision of Substantially Equivalent on September 29, 1995. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. American Dental Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1995
Date Received
September 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type