The following data is part of a premarket notification filed by Lang Dental Mfg. Co., Inc. with the FDA for Ortho-jet Acrylic Resin - Sparkle.
| Device ID | K941925 |
| 510k Number | K941925 |
| Device Name: | ORTHO-JET ACRYLIC RESIN - SPARKLE |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | LANG DENTAL MFG. CO., INC. 175 MESSNER DR. Wheeling, IL 60090 |
| Contact | Chan M Shen |
| Correspondent | Chan M Shen LANG DENTAL MFG. CO., INC. 175 MESSNER DR. Wheeling, IL 60090 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-20 |
| Decision Date | 1994-05-27 |