The following data is part of a premarket notification filed by Jedental Co., Inc. with the FDA for Profill Lc Composite.
| Device ID | K931880 |
| 510k Number | K931880 |
| Device Name: | PROFILL LC COMPOSITE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | JEDENTAL CO., INC. 16 SHAWNEE LN. Royersford, PA 19468 |
| Contact | Horace J Wilmer |
| Correspondent | Horace J Wilmer JEDENTAL CO., INC. 16 SHAWNEE LN. Royersford, PA 19468 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-14 |
| Decision Date | 1993-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889813001100 | K931880 | 000 |