The following data is part of a premarket notification filed by Millennium Dental Technologies, Inc. with the FDA for Periolase Nd:yag Pulsed Dental Laser System.
| Device ID | K182930 |
| 510k Number | K182930 |
| Device Name: | PerioLase Nd:YAG Pulsed Dental Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Millennium Dental Technologies, Inc. 10945 South Street, Suite 104-A Cerritos, CA 90703 |
| Contact | Robert H. Gregg |
| Correspondent | Robert H. Gregg Millennium Dental Technologies, Inc. 10945 South Street, Suite 104-A Cerritos, CA 90703 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-22 |
| Decision Date | 2019-07-12 |