Rolence Dental High Speed Handpiece, RHP

FDA 510(k) K093084 · Rolence Ent., Inc.

Substantially Equivalent

510(k) numberK093084

Submission

Device name
Rolence Dental High Speed Handpiece, RHP
Applicant
Rolence Ent., Inc.
Hsin Chu City, TW
Received
October 1, 2009
Decision date
December 16, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EFB – Handpiece, Air-Powered, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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Questions and answers

When was Rolence Dental High Speed Handpiece, RHP cleared by the FDA?

Rolence Dental High Speed Handpiece, RHP (K093084) received a 510(k) decision of Substantially Equivalent on December 16, 2009, 76 days after the submission was received.

What is the product code of K093084?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.