The following data is part of a premarket notification filed by Endo Twinn B.v. with the FDA for Endo Twinn.
| Device ID | K042870 |
| 510k Number | K042870 |
| Device Name: | ENDO TWINN |
| Classification | Gutta-percha |
| Applicant | ENDO TWINN B.V. DANZIGERKADE 17 Amsterdam, NL 1013 Ap |
| Contact | F.m. Verhoeven |
| Correspondent | J.a. Van Vugt KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-18 |
| Decision Date | 2005-01-11 |
| Summary: | summary |