The following data is part of a premarket notification filed by The Hygenic Corp. with the FDA for Solid Core Gutta Percha Carrier.
| Device ID | K905640 |
| 510k Number | K905640 |
| Device Name: | SOLID CORE GUTTA PERCHA CARRIER |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
| Contact | Meyer |
| Correspondent | Meyer THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-17 |
| Decision Date | 1991-03-05 |