The following data is part of a premarket notification filed by Dentaurum with the FDA for Contec Duo, Contec Lc, Contec Lcr.
| Device ID | K030644 |
| 510k Number | K030644 |
| Device Name: | CONTEC DUO, CONTEC LC, CONTEC LCR |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | DENTAURUM 10 PHEASANT RUN Newtown, PA 18940 |
| Contact | Jan W A Doorschodt |
| Correspondent | Jan W A Doorschodt DENTAURUM 10 PHEASANT RUN Newtown, PA 18940 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-28 |
| Decision Date | 2003-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J0111631310000 | K030644 | 000 |
| J011163321000 | K030644 | 000 |
| J011163307000 | K030644 | 000 |
| J011163312000 | K030644 | 000 |
| J0111631170000 | K030644 | 000 |
| J0111631180000 | K030644 | 000 |
| J0111631190000 | K030644 | 000 |
| J011163317000 | K030644 | 000 |
| J011163319000 | K030644 | 000 |
| J011163322000 | K030644 | 000 |
| J0111631001000 | K030644 | 000 |
| J0111631100000 | K030644 | 000 |
| J0111631110000 | K030644 | 000 |
| J0111631131000 | K030644 | 000 |
| J0111631150000 | K030644 | 000 |
| J0111631300000 | K030644 | 000 |
| J011163314000 | K030644 | 000 |