The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Dentsply Cavitron Jet Wave Air Polishing Prophylaxis System, Model G125.
Device ID | K041141 |
510k Number | K041141 |
Device Name: | DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 |
Classification | Handpiece, Air-powered, Dental |
Applicant | DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
Contact | P. Jeffery Lehn |
Correspondent | P. Jeffery Lehn DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-30 |
Decision Date | 2004-06-16 |
Summary: | summary |