The following data is part of a premarket notification filed by Abiomed, Inc. with the FDA for Abiodent Periotemp(r) System.
| Device ID | K911643 |
| 510k Number | K911643 |
| Device Name: | ABIODENT PERIOTEMP(R) SYSTEM |
| Classification | Gauge, Depth, Instrument, Dental |
| Applicant | ABIOMED, INC. 33 CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Bruce J Shook |
| Correspondent | Bruce J Shook ABIOMED, INC. 33 CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | EIL |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-12 |
| Decision Date | 1991-07-09 |