The following data is part of a premarket notification filed by Pentron Clinical Technologies with the FDA for Avante Led Curing Unit, Model N44.
| Device ID | K052349 |
| 510k Number | K052349 |
| Device Name: | AVANTE LED CURING UNIT, MODEL N44 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | PENTRON CLINICAL TECHNOLOGIES 68-70 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 |
| Contact | Greg Moreau |
| Correspondent | Greg Moreau PENTRON CLINICAL TECHNOLOGIES 68-70 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-29 |
| Decision Date | 2005-10-21 |
| Summary: | summary |