The following data is part of a premarket notification filed by The Hygenic Corp. with the FDA for Ultrafil-lt (gutta Percha).
| Device ID | K850863 |
| 510k Number | K850863 |
| Device Name: | ULTRAFIL-LT (GUTTA PERCHA) |
| Classification | Gutta-percha |
| 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 | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1985-04-16 |