Down Pak
FDA 510(k) K070246 · Endo Twinn B.V.
510(k) numberK070246
Submission
- Device name
- Down Pak
- Applicant
- Endo Twinn B.V.
Amsterdam, NL - Received
- January 25, 2007
- Decision date
- February 16, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EKM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K073369 | Ei Downpak Barrier SleevesEKM · Traditional | Hu-Friedy Mfg. Co., Inc. | 02/27/2008SE |
| K051573 | TGP (Gutta Percha Containing Tetracycline or Doxycycline)EKM · Traditional | Dr. Howard Martin, P.A. | 06/26/2006SE |
| K042870 | Endo TwinnEKM · Traditional | Endo Twinn B.V. | 01/11/2005SE |
| K023819 | Fiberfill SGPEKM · Traditional | Pentron Clinical Technologies | 03/26/2003SE |
| K971641 | Antibacterial Gutta PerchaEKM · Traditional | Dr. Howard Martin, P.A. | 07/21/1997SE |
| K970134 | Thermaprep Plus OvenEKM · Traditional | Tulsa Dental Products, Ltd. | 03/21/1997SE |
| K931742 | Inject-R FillEKM · Traditional | Union Broach, Div. Moyco Industries, Inc. | 05/27/1993SE |
| K924825 | Microdose Rc-EzEKM · Traditional | Unicep | 03/05/1993SE |
| K915243 | Touch 'N Heat Model 5002, ModificationEKM · Traditional | Analytic Technology | 01/21/1992SE |
| K910224 | ThermaprepEKM · Traditional | Tulsa Dental Products, Ltd. | 03/29/1991SE |
More from Tulsa Dental Products, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K042870 | Endo TwinnEKM · Traditional | 01/11/2005SE |
Questions and answers
When was Down Pak cleared by the FDA?
Down Pak (K070246) received a 510(k) decision of Substantially Equivalent on February 16, 2007, 22 days after the submission was received.
What is the product code of K070246?
The FDA product code is EKM – Gutta-Percha, a Class I (low risk) device regulated under 21 CFR 872.3850.