The following data is part of a premarket notification filed by J.f. Jelenko & Co., Inc. with the FDA for Jeldent Multicryl.
| Device ID | K990056 |
| 510k Number | K990056 |
| Device Name: | JELDENT MULTICRYL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504 |
| Contact | Raphael Judkins |
| Correspondent | Raphael Judkins J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-07 |
| Decision Date | 1999-03-25 |