K033227 is an FDA 510(k) clearance for the LUXAFORM PLUS. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on January 16, 2004, 102 days after receiving the submission on October 6, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K033227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 2003 |
| Decision Date | January 16, 2004 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |