The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Dent-o-cryl Orthodontic Acrylic.
| Device ID | K942667 |
| 510k Number | K942667 |
| Device Name: | DENT-O-CRYL ORTHODONTIC ACRYLIC |
| Classification | Positioner, Tooth, Preformed |
| Applicant | DENTAURAUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Contact | John J Roth |
| Correspondent | John J Roth DENTAURAUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Product Code | KMY |
| CFR Regulation Number | 872.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-06 |
| Decision Date | 1995-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J011160011000 | K942667 | 000 |
| J011160100400 | K942667 | 000 |
| J011160100390 | K942667 | 000 |
| J011160100340 | K942667 | 000 |
| J011160100310 | K942667 | 000 |
| J011160100300 | K942667 | 000 |
| J011160100290 | K942667 | 000 |
| J011160100280 | K942667 | 000 |
| J011160100270 | K942667 | 000 |
| J011160100410 | K942667 | 000 |
| J011160100420 | K942667 | 000 |
| J011160301000 | K942667 | 000 |
| J011160300000 | K942667 | 000 |
| J011160212000 | K942667 | 000 |
| J011160112000 | K942667 | 000 |
| J011160100460 | K942667 | 000 |
| J011160100450 | K942667 | 000 |
| J011160100440 | K942667 | 000 |
| J011160100430 | K942667 | 000 |
| J011160100190 | K942667 | 000 |
| J011160100180 | K942667 | 000 |
| J011160100050 | K942667 | 000 |
| J011160100040 | K942667 | 000 |
| J011160100020 | K942667 | 000 |
| J011160100010 | K942667 | 000 |
| J011160100000 | K942667 | 000 |
| J011160014000 | K942667 | 000 |
| J011160013000 | K942667 | 000 |
| J011160012000 | K942667 | 000 |
| J011160100060 | K942667 | 000 |
| J011160100070 | K942667 | 000 |
| J011160100160 | K942667 | 000 |
| J011160100150 | K942667 | 000 |
| J011160100140 | K942667 | 000 |
| J011160100130 | K942667 | 000 |
| J011160100120 | K942667 | 000 |
| J011160100110 | K942667 | 000 |
| J011160100100 | K942667 | 000 |
| J011160100090 | K942667 | 000 |
| J011160400000 | K942667 | 000 |
| J011160400200 | K942667 | 000 |
| J011161300000 | K942667 | 000 |
| J011161229000 | K942667 | 000 |
| J011161227000 | K942667 | 000 |
| J011161150000 | K942667 | 000 |
| J011161138000 | K942667 | 000 |
| J011161137000 | K942667 | 000 |
| J011161136000 | K942667 | 000 |
| J011161135000 | K942667 | 000 |
| J011161350000 | K942667 | 000 |
| J011161605000 | K942667 | 000 |
| J011161912000 | K942667 | 000 |
| J011161622000 | K942667 | 000 |
| J011161620000 | K942667 | 000 |
| J011161611000 | K942667 | 000 |
| J011161609000 | K942667 | 000 |
| J011161608000 | K942667 | 000 |
| J011161607000 | K942667 | 000 |
| J011161606000 | K942667 | 000 |
| J011161134000 | K942667 | 000 |
| J011161133000 | K942667 | 000 |
| J011160501000 | K942667 | 000 |
| J011160410000 | K942667 | 000 |
| J011160406000 | K942667 | 000 |
| J011160405000 | K942667 | 000 |
| J011160404000 | K942667 | 000 |
| J011160403000 | K942667 | 000 |
| J011160402000 | K942667 | 000 |
| J011160401000 | K942667 | 000 |
| J011160502000 | K942667 | 000 |
| J011160600000 | K942667 | 000 |
| J011161132000 | K942667 | 000 |
| J011161131000 | K942667 | 000 |
| J011161130000 | K942667 | 000 |
| J011161129000 | K942667 | 000 |
| J011161128000 | K942667 | 000 |
| J011161127000 | K942667 | 000 |
| J011161100000 | K942667 | 000 |
| J011160700000 | K942667 | 000 |
| J011161139000 | K942667 | 000 |