The following data is part of a premarket notification filed by Teledyne Getz with the FDA for Teledyne Getz's Disposable Prophy Angle.
Device ID | K901239 |
510k Number | K901239 |
Device Name: | TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE |
Classification | Handpiece, Air-powered, Dental |
Applicant | TELEDYNE GETZ 1550 GREENLEAF AVE. Elk Grove Village, IL 60007 -5525 |
Contact | Gabriel Lebovic |
Correspondent | Gabriel Lebovic TELEDYNE GETZ 1550 GREENLEAF AVE. Elk Grove Village, IL 60007 -5525 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-15 |
Decision Date | 1990-05-15 |