The following data is part of a premarket notification filed by Lang Dental Mfg. Co., Inc. with the FDA for Lang Dental Resin A97 Fibred Pink.
| Device ID | K972553 |
| 510k Number | K972553 |
| Device Name: | LANG DENTAL RESIN A97 FIBRED PINK |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | LANG DENTAL MFG. CO., INC. 175 MESSNER DR. Wheeling, IL 60090 |
| Contact | Chah M Shen |
| Correspondent | Chah 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 | 1997-07-08 |
| Decision Date | 1997-11-13 |