The following data is part of a premarket notification filed by Millennium Dental Technologies, Inc. with the FDA for Periolase Nd:yag Dental Laser System.
| Device ID | K030290 |
| 510k Number | K030290 |
| Device Name: | PERIOLASE ND:YAG DENTAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MILLENNIUM DENTAL TECHNOLOGIES, INC. 4256 HEYER AVE. Castro Valley, CA 94546 |
| Contact | David M Harris |
| Correspondent | David M Harris MILLENNIUM DENTAL TECHNOLOGIES, INC. 4256 HEYER AVE. Castro Valley, CA 94546 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-23 |
| Decision Date | 2004-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D808VIII1 | K030290 | 000 |