The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Dentaurum Space Maintainer.
| Device ID | K935856 |
| 510k Number | K935856 |
| Device Name: | DENTAURUM SPACE MAINTAINER |
| Classification | Maintainer, Space Preformed, Orthodontic |
| Applicant | DENTAURAUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Contact | John J Roth, Jr |
| Correspondent | John J Roth, Jr DENTAURAUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Product Code | DYT |
| CFR Regulation Number | 872.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-08 |
| Decision Date | 1994-04-28 |