510(k) K901239

TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE by Teledyne Getz — Product Code EFB

K901239 is an FDA 510(k) premarket notification submitted by Teledyne Getz for the device "TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE". The FDA issued a decision of Substantially Equivalent on May 15, 1990. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Teledyne Getz has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1990
Date Received
March 15, 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