The following data is part of a premarket notification filed by Dentalez, Inc with the FDA for Titan 3 Low Speed Angle Attachments.
| Device ID | K162397 |
| 510k Number | K162397 |
| Device Name: | Titan 3 Low Speed Angle Attachments |
| Classification | Handpiece, Contra- And Right-angle Attachment, 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 | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-26 |
| Decision Date | 2017-01-19 |
| Summary: | summary |