The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Cement It! Universal C&b.
| Device ID | K000173 |
| 510k Number | K000173 |
| Device Name: | CEMENT IT! UNIVERSAL C&B |
| Classification | Cement, Dental |
| Applicant | JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Contact | Annmarie Tenero |
| Correspondent | Annmarie Tenero JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-20 |
| Decision Date | 2000-02-29 |