510(k) K874294

AUTOCHUCK ATTACHMENT by Den-Tal-Ez Mfg Co., Inc. — Product Code EFB

K874294 is an FDA 510(k) premarket notification submitted by Den-Tal-Ez Mfg Co., Inc. for the device "AUTOCHUCK ATTACHMENT". The FDA issued a decision of Substantially Equivalent on December 29, 1987. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Den-Tal-Ez Mfg Co., Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1987
Date Received
October 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type