The following data is part of a premarket notification filed by Dentalez, Inc. with the FDA for 430 Torque High-speed Handpiece Series - 430 Swl Torque High Speed Handpiece, 430 Sw Torque High Speed Handpiece.
Device ID | K153411 |
510k Number | K153411 |
Device Name: | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece |
Classification | Handpiece, Air-powered, Dental |
Applicant | DENTALEZ, INC. 1816 COLONIAL VILLAGE LANE Lancaster, PA 17601 |
Contact | Dan Laskowitz |
Correspondent | Dan Laskowitz DENTALEZ, INC. 1816 COLONIAL VILLAGE LANE Lancaster, PA 17601 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-25 |
Decision Date | 2016-04-08 |
Summary: | summary |