The following data is part of a premarket notification filed by Dentalez Group with the FDA for Handpiece Fiber Optic System Improvement Feature.
| Device ID | K896361 |
| 510k Number | K896361 |
| Device Name: | HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DENTALEZ GROUP 1818 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | Donald I Gonser |
| Correspondent | Donald I Gonser DENTALEZ GROUP 1818 COLONIAL VILLAGE LN. 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 | 1989-11-06 |
| Decision Date | 1990-02-02 |