The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Tooth Preparation Conditioner, Pre-impression.
| Device ID | K952240 |
| 510k Number | K952240 |
| Device Name: | TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Contact | Arun Prasad |
| Correspondent | Arun Prasad JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-12 |
| Decision Date | 1995-08-18 |