Challenger/Classic Push Button Handpiece

Q: What is the product code of K080240?

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

FDA 510(k) K080240 · Promident, LLC

Substantially Equivalent

510(k) numberK080240

Submission

Device name: Challenger/Classic Push Button Handpiece
Applicant: Promident, LLC
New City, NY, US
Received: January 31, 2008
Decision date: February 7, 2008
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA
Third-party review: Yes

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 Challenger/Classic Push Button Handpiece cleared by the FDA?

Challenger/Classic Push Button Handpiece (K080240) received a 510(k) decision of Substantially Equivalent on February 7, 2008, 7 days after the submission was received.

What is the product code of K080240?

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