The following data is part of a premarket notification filed by Den-mat Holdings, Llc with the FDA for Sapphire Plasma Arc Dental Curing Light.
| Device ID | K081287 |
| 510k Number | K081287 |
| Device Name: | SAPPHIRE PLASMA ARC DENTAL CURING LIGHT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DEN-MAT HOLDINGS, LLC 2727 SKYWAY DR. Santa Maria, CA 93455 |
| Contact | Alan Matthews |
| Correspondent | Alan Matthews DEN-MAT HOLDINGS, LLC 2727 SKYWAY DR. Santa Maria, CA 93455 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-07 |
| Decision Date | 2008-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813033968000L0 | K081287 | 000 |
| D8130339680000 | K081287 | 000 |
| D813033958000L0 | K081287 | 000 |
| D8130339587010 | K081287 | 000 |