The following data is part of a premarket notification filed by Fairfax Dental, Inc. with the FDA for Stabident Local Anesthesia System.
| Device ID | K910446 |
| 510k Number | K910446 |
| Device Name: | STABIDENT LOCAL ANESTHESIA SYSTEM |
| Classification | Needle, Dental |
| Applicant | FAIRFAX DENTAL, INC. 2601 SOUTH BAYSHORE DR., SUITE 875 Miami, FL 33133 |
| Contact | G. C Kay |
| Correspondent | G. C Kay FAIRFAX DENTAL, INC. 2601 SOUTH BAYSHORE DR., SUITE 875 Miami, FL 33133 |
| Product Code | DZM |
| CFR Regulation Number | 872.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-14 |
| Decision Date | 1991-06-03 |