The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Dentaurum Ceramic Debonding Unit.
| Device ID | K902018 |
| 510k Number | K902018 |
| Device Name: | DENTAURUM CERAMIC DEBONDING UNIT |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | DENTAURAUM, INC. 2 PHEASANT RUN Newtown, PA 18940 |
| Contact | Roth, Jr |
| Correspondent | Roth, Jr DENTAURAUM, INC. 2 PHEASANT RUN Newtown, PA 18940 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-03 |
| Decision Date | 1991-04-03 |