The following data is part of a premarket notification filed by Discus Dental, Llc with the FDA for Sl3.
| Device ID | K102639 |
| 510k Number | K102639 |
| Device Name: | SL3 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DISCUS DENTAL, LLC 8550 HIGUERA ST. Culver City, CA 90232 |
| Contact | Clark D Vonahsen |
| Correspondent | Clark D Vonahsen DISCUS DENTAL, LLC 8550 HIGUERA ST. Culver City, CA 90232 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-14 |
| Decision Date | 2010-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813ZLR2006A1 | K102639 | 000 |
| D813ZLR2005A1 | K102639 | 000 |
| D813ZLR20040 | K102639 | 000 |