The following data is part of a premarket notification filed by Garrison Dental Solutions, Llc with the FDA for Loop Led Curing Light System.
| Device ID | K200775 |
| 510k Number | K200775 |
| Device Name: | LOOP LED Curing Light System |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | Garrison Dental Solutions, LLC 150 DeWitt Lane Spring Lake, MI 49456 |
| Contact | Alex Hull |
| Correspondent | Michael Tomasovich Regulatory Affairs Associates, LLC 4761 Tara Court West Bloomfield, MI 48323 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-25 |
| Decision Date | 2020-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810038096506 | K200775 | 000 |
| 00810038096476 | K200775 | 000 |
| 00810038093604 | K200775 | 000 |
| 00810038093550 | K200775 | 000 |
| 00810038093536 | K200775 | 000 |