Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements
FDA 510(k) K073478 · Sybron Dental Specialties, Inc.
510(k) numberK073478
Submission
- Device name
- Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements
- Applicant
- Sybron Dental Specialties, Inc.
Orange, CA, US - Received
- December 11, 2007
- Decision date
- September 3, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements cleared by the FDA?
Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements (K073478) received a 510(k) decision of Substantially Equivalent on September 3, 2008, 267 days after the submission was received.
What is the product code of K073478?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.