Rapidd Highspeed Dental Handpiece
FDA 510(k) K003518 · Dentsply Intl.
510(k) numberK003518
Submission
- Device name
- Rapidd Highspeed Dental Handpiece
- Applicant
- Dentsply Intl.
York, PA, US - Received
- November 15, 2000
- Decision date
- January 9, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Rapidd Highspeed Dental Handpiece cleared by the FDA?
Rapidd Highspeed Dental Handpiece (K003518) received a 510(k) decision of Substantially Equivalent on January 9, 2001, 55 days after the submission was received.
What is the product code of K003518?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.