Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low Speed Straight Handpieces
FDA 510(k) K112305 · Thunder Tiger Corp.
510(k) numberK112305
Submission
- Device name
- Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low Speed Straight Handpieces
- Applicant
- Thunder Tiger Corp.
Taichung, TW - Received
- August 11, 2011
- Decision date
- April 17, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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| K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202EFB · Traditional | 01/20/2006SE |
Questions and answers
When was Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low Speed Straight Handpieces cleared by the FDA?
Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low Speed Straight Handpieces (K112305) received a 510(k) decision of Substantially Equivalent on April 17, 2012, 250 days after the submission was received.
What is the product code of K112305?
The FDA product code is EGS – Handpiece, Contra- And Right-Angle Attachment, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.