T1 Control High Speed Dental Handpiece
FDA 510(k) K965238 · Siemens AG
510(k) numberK965238
Submission
- Device name
- T1 Control High Speed Dental Handpiece
- Applicant
- Siemens AG
North Attleboro, MA, US - Received
- December 31, 1996
- Decision date
- March 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was T1 Control High Speed Dental Handpiece cleared by the FDA?
T1 Control High Speed Dental Handpiece (K965238) received a 510(k) decision of Substantially Equivalent on March 19, 1997, 78 days after the submission was received.
What is the product code of K965238?
The FDA product code is EFA – Handpiece, Belt And/Or Gear Driven, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.