The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Extraoral Headgear.
| Device ID | K936151 |
| 510k Number | K936151 |
| Device Name: | EXTRAORAL HEADGEAR |
| Classification | Headgear, Extraoral, 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 | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-27 |
| Decision Date | 1994-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J011745032000 | K936151 | 000 |
| J011744614000 | K936151 | 000 |
| J011744112010 | K936151 | 000 |
| J011744101010 | K936151 | 000 |
| J011745404000 | K936151 | 000 |
| J011745022000 | K936151 | 000 |
| J011745021000 | K936151 | 000 |
| J011745020000 | K936151 | 000 |
| J011744711500 | K936151 | 000 |
| J011745403000 | K936151 | 000 |
| J011745024000 | K936151 | 000 |
| J011744616000 | K936151 | 000 |
| J011744615010 | K936151 | 000 |
| J011744706000 | K936151 | 000 |
| J011744709000 | K936151 | 000 |
| J011744715000 | K936151 | 000 |
| J011744705000 | K936151 | 000 |
| J011744717000 | K936151 | 000 |
| J011744713000 | K936151 | 000 |
| J011744712000 | K936151 | 000 |
| J011745402000 | K936151 | 000 |
| J011745041000 | K936151 | 000 |
| J011745039000 | K936151 | 000 |
| J011745038000 | K936151 | 000 |
| J011745027000 | K936151 | 000 |
| J011745023000 | K936151 | 000 |
| J011744710000 | K936151 | 000 |
| J011744613000 | K936151 | 000 |