The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Dentaurum Bracket Positioning Gauge.
| Device ID | K935153 |
| 510k Number | K935153 |
| Device Name: | DENTAURUM BRACKET POSITIONING GAUGE |
| Classification | Aligner, Bracket, 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 | ECQ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-28 |
| Decision Date | 1994-01-31 |