The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Dentaurum Steel Ligature Wires.
| Device ID | K935140 |
| 510k Number | K935140 |
| Device Name: | DENTAURUM STEEL LIGATURE WIRES |
| Classification | Wire, 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 | DZC |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-28 |
| Decision Date | 1994-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J011764060000 | K935140 | 000 |
| J011766275000 | K935140 | 000 |
| J011764003100 | K935140 | 000 |
| J011764022000 | K935140 | 000 |
| J011766285000 | K935140 | 000 |
| J011766284000 | K935140 | 000 |
| J011766282000 | K935140 | 000 |
| J011766281000 | K935140 | 000 |
| J011766280000 | K935140 | 000 |
| J011766279000 | K935140 | 000 |
| J011766278000 | K935140 | 000 |
| J011766274000 | K935140 | 000 |
| J011766273000 | K935140 | 000 |
| J011766272000 | K935140 | 000 |
| J011766271000 | K935140 | 000 |
| J011766270000 | K935140 | 000 |
| J011765113000 | K935140 | 000 |
| J011766276000 | K935140 | 000 |
| J011766277000 | K935140 | 000 |
| J011520090000 | K935140 | 000 |
| J011764028000 | K935140 | 000 |
| J011766018000 | K935140 | 000 |
| J011768004000 | K935140 | 000 |
| J011764061000 | K935140 | 000 |
| J011764058000 | K935140 | 000 |
| J011764057000 | K935140 | 000 |
| J011764056000 | K935140 | 000 |
| J011764055000 | K935140 | 000 |
| J011520062000 | K935140 | 000 |
| J011764015000 | K935140 | 000 |
| J011764015100 | K935140 | 000 |
| J011764013000 | K935140 | 000 |
| J011764023000 | K935140 | 000 |
| J011764002000 | K935140 | 000 |
| J011764000000 | K935140 | 000 |
| J011764012000 | K935140 | 000 |