The following data is part of a premarket notification filed by Msq (m2) Ltd. with the FDA for Dio-dent 10 Dental Diode Laser.
| Device ID | K031819 |
| 510k Number | K031819 |
| Device Name: | DIO-DENT 10 DENTAL DIODE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MSQ (M2) LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Contact | Arava Hacohen |
| Correspondent | Arava Hacohen MSQ (M2) LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-12 |
| Decision Date | 2003-10-30 |
| Summary: | summary |