The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Amd Dentist And Hygienist Kits.
| Device ID | K925115 |
| 510k Number | K925115 |
| Device Name: | AMD DENTIST AND HYGIENIST KITS |
| Classification | Burnisher, Operative |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Contact | Ronald D Arkin |
| Correspondent | Ronald D Arkin ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-09 |
| Decision Date | 1994-07-05 |