510(k) K905542

LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS by Lares Research, Inc. — Product Code EFB

K905542 is an FDA 510(k) premarket notification submitted by Lares Research, Inc. for the device "LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS". The FDA issued a decision of Substantially Equivalent on March 11, 1991. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Lares Research, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1991
Date Received
December 11, 1990
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