The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Q3 (light And Universal) Impression Material.
| Device ID | K923202 |
| 510k Number | K923202 |
| Device Name: | Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Contact | Arun Prasad |
| Correspondent | Arun Prasad JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-30 |
| Decision Date | 1992-08-27 |