The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Dentaurum Olympia Latex-elastics And Dentaurum Latex-elastics.
| Device ID | K935144 |
| 510k Number | K935144 |
| Device Name: | DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS |
| Classification | Band, Elastic, 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 | ECI |
| 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 |
|---|---|---|
| J011772517000 | K935144 | 000 |
| J011772127000 | K935144 | 000 |
| J011772126000 | K935144 | 000 |
| J011772125000 | K935144 | 000 |
| J011772124000 | K935144 | 000 |
| J011772123000 | K935144 | 000 |
| J011772119000 | K935144 | 000 |
| J011772117000 | K935144 | 000 |
| J011772116000 | K935144 | 000 |
| J011772114000 | K935144 | 000 |
| J011772113000 | K935144 | 000 |
| J011772109000 | K935144 | 000 |
| J011772107000 | K935144 | 000 |
| J011772106000 | K935144 | 000 |
| J011772104000 | K935144 | 000 |
| J011772103000 | K935144 | 000 |
| J011772200000 | K935144 | 000 |
| J011772203010 | K935144 | 000 |
| J011772527000 | K935144 | 000 |
| J011772210010 | K935144 | 000 |
| J011772208010 | K935144 | 000 |
| J011772206010 | K935144 | 000 |
| J011772210021 | K935144 | 000 |
| J011772208021 | K935144 | 000 |
| J011772205021 | K935144 | 000 |
| J011772204021 | K935144 | 000 |
| J011772203021 | K935144 | 000 |
| J011772526000 | K935144 | 000 |
| J011772524000 | K935144 | 000 |
| J011772516000 | K935144 | 000 |
| J011772514000 | K935144 | 000 |
| J011772205010 | K935144 | 000 |
| J011772204010 | K935144 | 000 |
| J011772100000 | K935144 | 000 |