The following data is part of a premarket notification filed by Dyna-pace Systems, Inc. with the FDA for Eco/dental General Dental Pack.
| Device ID | K922988 |
| 510k Number | K922988 |
| Device Name: | ECO/DENTAL GENERAL DENTAL PACK |
| Classification | Burnisher, Operative |
| Applicant | DYNA-PACE SYSTEMS, INC. 8735 DUNWOODY PLACE SUITE 5 Atlanta, GA 30350 |
| Contact | Fredrick L Aycock |
| Correspondent | Fredrick L Aycock DYNA-PACE SYSTEMS, INC. 8735 DUNWOODY PLACE SUITE 5 Atlanta, GA 30350 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-22 |
| Decision Date | 1992-11-04 |