The following data is part of a premarket notification filed by Pelton & Crane Co. with the FDA for Cerec 2.
| Device ID | K950299 |
| 510k Number | K950299 |
| Device Name: | CEREC 2 |
| Classification | Material, Impression |
| Applicant | PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800 |
| Contact | Kristi Kunkel |
| Correspondent | Kristi Kunkel PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-25 |
| Decision Date | 1995-05-23 |