The following data is part of a premarket notification filed by Continuum Electro-optics, Inc. with the FDA for Diodent Dental Laser System.
| Device ID | K013216 |
| 510k Number | K013216 |
| Device Name: | DIODENT DENTAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CONTINUUM ELECTRO-OPTICS, INC. 3150 CENTRAL EXPRESSWAY Santa Clara, CA 95051 |
| Contact | Ronald Kohlhardt |
| Correspondent | Ronald Kohlhardt CONTINUUM ELECTRO-OPTICS, INC. 3150 CENTRAL EXPRESSWAY Santa Clara, CA 95051 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-26 |
| Decision Date | 2002-02-27 |
| Summary: | summary |