The following data is part of a premarket notification filed by Mds with the FDA for The Bi-directional Spiral & Epoxy Root Canal Cement System.
| Device ID | K992727 |
| 510k Number | K992727 |
| Device Name: | THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM |
| Classification | Resin, Root Canal Filling |
| Applicant | MDS 55 NORTHERN BLVD., SUITE 200 New York, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MDS 55 NORTHERN BLVD., SUITE 200 New York, NY 11021 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-13 |
| Decision Date | 2000-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766054000150 | K992727 | 000 |
| 00766054000143 | K992727 | 000 |
| 00766054000136 | K992727 | 000 |
| 00766054000129 | K992727 | 000 |