The following data is part of a premarket notification filed by Implant Support Systems, Inc. with the FDA for Dental Hand Instruments.
| Device ID | K892239 |
| 510k Number | K892239 |
| Device Name: | DENTAL HAND INSTRUMENTS |
| Classification | Burnisher, Operative |
| Applicant | IMPLANT SUPPORT SYSTEMS, INC. 4790 IRVINE BLVD. #105-137 Irvine, CA 92720 |
| Contact | Brian Hill |
| Correspondent | Brian Hill IMPLANT SUPPORT SYSTEMS, INC. 4790 IRVINE BLVD. #105-137 Irvine, CA 92720 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-23 |
| Decision Date | 1989-05-18 |