Star E900 Handpiece Series

FDA 510(k) K240183 · Dentalez, Inc., Stardental Division

Substantially Equivalent

510(k) numberK240183

Submission

Device name
Star E900 Handpiece Series
Applicant
Dentalez, Inc., Stardental Division
Lancaster, PA, US
Received
January 23, 2024
Decision date
September 19, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EGS – Handpiece, Contra- And Right-Angle Attachment, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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Questions and answers

When was Star E900 Handpiece Series cleared by the FDA?

Star E900 Handpiece Series (K240183) received a 510(k) decision of Substantially Equivalent on September 19, 2024, 240 days after the submission was received.

What is the product code of K240183?

The FDA product code is EGS – Handpiece, Contra- And Right-Angle Attachment, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.