The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Splint It.
| Device ID | K972985 |
| 510k Number | K972985 |
| Device Name: | SPLINT IT |
| Classification | Splint, Endodontic Stabilizing |
| Applicant | JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Contact | Murray G Gamberg |
| Correspondent | Murray G Gamberg JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Product Code | ELS |
| CFR Regulation Number | 872.3890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-11 |
| Decision Date | 1997-09-24 |