Submission Details
| 510(k) Number | K042870 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 18, 2004 |
| Decision Date | January 11, 2005 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
ENDO TWINN
Jan 2005
Decision
85d
Days
Class 1
Risk
About This 510(k) Submission
K042870 is an FDA 510(k) clearance for the ENDO TWINN, 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 January 11, 2005, 85 days after receiving the submission on October 18, 2004. 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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