The following data is part of a premarket notification filed by Endo Twinn B.v. with the FDA for Down Pak.
| Device ID | K070246 |
| 510k Number | K070246 |
| Device Name: | DOWN PAK |
| Classification | Gutta-percha |
| Applicant | ENDO TWINN B.V. DANZIGERKADE 17 Amsterdam, NL 1013 Ap |
| Contact | F.m. Verhoeven |
| Correspondent | F.m. Verhoeven ENDO TWINN B.V. DANZIGERKADE 17 Amsterdam, NL 1013 Ap |
| Product Code | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-25 |
| Decision Date | 2007-02-16 |
| Summary: | summary |