Submission Details
| 510(k) Number | K100606 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 03, 2010 |
| Decision Date | May 28, 2010 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
VATEA ENDONTIC IRRIGATION SYSTEM
May 2010
Decision
86d
Days
Class 1
Risk
About This 510(k) Submission
K100606 is an FDA 510(k) clearance for the VATEA ENDONTIC IRRIGATION SYSTEM, a Handpiece, Air-powered, Root Canal Irrigation (Class I — General Controls, product code NYL), submitted by Redent-Nova , Ltd. (Washington, US). The FDA issued a Cleared decision on May 28, 2010, 86 days after receiving the submission on March 3, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.
Device Classification
| Product Code | NYL — Handpiece, Air-powered, Root Canal Irrigation |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4200 |
| Definition | To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation. |
Manufacturer
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