The following data is part of a premarket notification filed by Ora-gard, Inc. with the FDA for The Davis Disposable Protective Splint.
| Device ID | K924333 |
| 510k Number | K924333 |
| Device Name: | THE DAVIS DISPOSABLE PROTECTIVE SPLINT |
| Classification | Block, Bite |
| Applicant | ORA-GARD, INC. P.O. BOX 50303 Knoxville, TN 37950 |
| Contact | Mike Milner |
| Correspondent | Mike Milner ORA-GARD, INC. P.O. BOX 50303 Knoxville, TN 37950 |
| Product Code | JXL |
| CFR Regulation Number | 882.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-27 |
| Decision Date | 1993-04-23 |