Air Torx, Model TRA-200, TRA-200-CP3, TRA-200-CP4
FDA 510(k) K091065 · J. Morita USA, Inc.
510(k) numberK091065
Submission
- Device name
- Air Torx, Model TRA-200, TRA-200-CP3, TRA-200-CP4
- Applicant
- J. Morita USA, Inc.
Washington, DC, US - Received
- April 14, 2009
- Decision date
- October 16, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Air Torx, Model TRA-200, TRA-200-CP3, TRA-200-CP4 cleared by the FDA?
Air Torx, Model TRA-200, TRA-200-CP3, TRA-200-CP4 (K091065) received a 510(k) decision of Substantially Equivalent on October 16, 2009, 185 days after the submission was received.
What is the product code of K091065?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.