Dentsply Cavitron Jet Wave Air Polishing Prophylaxis System, Model G125
FDA 510(k) K041141 · Dentsply Intl.
510(k) numberK041141
Submission
- Device name
- Dentsply Cavitron Jet Wave Air Polishing Prophylaxis System, Model G125
- Applicant
- Dentsply Intl.
York, PA, US - Received
- April 30, 2004
- Decision date
- June 16, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Dentsply Cavitron Jet Wave Air Polishing Prophylaxis System, Model G125 cleared by the FDA?
Dentsply Cavitron Jet Wave Air Polishing Prophylaxis System, Model G125 (K041141) received a 510(k) decision of Substantially Equivalent on June 16, 2004, 47 days after the submission was received.
What is the product code of K041141?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.