The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Cerec3 Vitablocks.
| Device ID | K012517 |
| 510k Number | K012517 |
| Device Name: | CEREC3 VITABLOCKS |
| Classification | Material, Impression |
| Applicant | SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-11-01 |
| Summary: | summary |