The following data is part of a premarket notification filed by Hines Group Ltd. with the FDA for Oralvue Dental Mirror.
| Device ID | K946073 |
| 510k Number | K946073 |
| Device Name: | ORALVUE DENTAL MIRROR |
| Classification | Mirror, Mouth |
| Applicant | HINES GROUP LTD. 1562 FIRST AVE. SUITE 356 Nyw York, NY 10028 |
| Contact | Randalph Dines |
| Correspondent | Randalph Dines HINES GROUP LTD. 1562 FIRST AVE. SUITE 356 Nyw York, NY 10028 |
| Product Code | EAX |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-07 |
| Decision Date | 1995-02-16 |