The following data is part of a premarket notification filed by The Hygenic Corp. with the FDA for Dental Endodontic Cement (modification).
| Device ID | K894092 |
| 510k Number | K894092 |
| Device Name: | DENTAL ENDODONTIC CEMENT (MODIFICATION) |
| Classification | Resin, Root Canal Filling |
| Applicant | THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
| Contact | T. N Meyer |
| Correspondent | T. N Meyer THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-08 |
| Decision Date | 1990-01-10 |