CST61 High Speed Turbine Handpiece

FDA 510(k) K063110 · Shanghai Dental Instrument Factory

Substantially Equivalent

510(k) numberK063110

Submission

Device name
CST61 High Speed Turbine Handpiece
Applicant
Shanghai Dental Instrument Factory
Roswell, GA, US
Received
October 11, 2006
Decision date
October 26, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
EFB – Handpiece, Air-Powered, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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More from Ttbio Corp.

510(k)DeviceDecision
K063302Sdif Dental Chair with Operative Unit and AccessoriesEIA · Traditional 11/15/2006SE

Questions and answers

When was CST61 High Speed Turbine Handpiece cleared by the FDA?

CST61 High Speed Turbine Handpiece (K063110) received a 510(k) decision of Substantially Equivalent on October 26, 2006, 15 days after the submission was received.

What is the product code of K063110?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.