Century Model 105C
FDA 510(k) K093341 · Sybron Dental Specialties, Inc.
510(k) numberK093341
Submission
- Device name
- Century Model 105C
- Applicant
- Sybron Dental Specialties, Inc.
Orange, CA, US - Received
- October 23, 2009
- Decision date
- April 5, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Century Model 105C cleared by the FDA?
Century Model 105C (K093341) received a 510(k) decision of Substantially Equivalent on April 5, 2010, 164 days after the submission was received.
What is the product code of K093341?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.