The following data is part of a premarket notification filed by Bien Air Usa, Inc. with the FDA for Orl-e-92 Surgical Drill System.
| Device ID | K984244 |
| 510k Number | K984244 |
| Device Name: | ORL-E-92 SURGICAL DRILL SYSTEM |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | BIEN AIR USA, INC. 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson BIEN AIR USA, INC. 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-27 |
| Decision Date | 1999-02-23 |
| Summary: | summary |