510(k) K994368

AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS by American Dental Products, Inc. — Product Code LFC

K994368 is an FDA 510(k) premarket notification submitted by American Dental Products, Inc. for the device "AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS". The FDA issued a decision of Substantially Equivalent on March 14, 2000. The device falls under product code LFC (Device, Caries Detection), a Class II device regulated under 21 CFR 872.1740. American Dental Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2000
Date Received
December 27, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Caries Detection
Device Class
Class II
Regulation Number
872.1740
Review Panel
DE
Submission Type