The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Demetron A.2.
| Device ID | K063116 |
| 510k Number | K063116 |
| Device Name: | DEMETRON A.2 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | SYBRON DENTAL SPECIALTIES 100 BAYVIEW CIRCLE SUITE 6000 Newport Beach, CA 92660 -8915 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES 100 BAYVIEW CIRCLE SUITE 6000 Newport Beach, CA 92660 -8915 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-12 |
| Decision Date | 2006-12-05 |
| Summary: | summary |