Submission Details
| 510(k) Number | K070246 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 25, 2007 |
| Decision Date | February 16, 2007 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Special
DOWN PAK
Feb 2007
Decision
22d
Days
Class 1
Risk
About This 510(k) Submission
K070246 is an FDA 510(k) clearance for the DOWN PAK, a Gutta-percha (Class I — General Controls, product code EKM), submitted by Endo Twinn B.V. (Amsterdam, NL). The FDA issued a Cleared decision on February 16, 2007, 22 days after receiving the submission on January 25, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3850.
Device Classification
| Product Code | EKM — Gutta-percha |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.3850 |
Manufacturer
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