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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7022688440 | K153411 | 000 |
| D7022637720 | K153411 | 000 |
| D7022637730 | K153411 | 000 |
| D7022654000 | K153411 | 000 |
| D7022656460 | K153411 | 000 |
| D7022658900 | K153411 | 000 |
| D7022658910 | K153411 | 000 |
| D7022658920 | K153411 | 000 |
| D7022662130 | K153411 | 000 |
| D7022688420 | K153411 | 000 |
| D7022688430 | K153411 | 000 |
| D7022637580 | K153411 | 000 |