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510(k) K221814

OK Handpiece by Jaintek Co.,Ltd — Product Code EFB

K221814 is an FDA 510(k) premarket notification submitted by Jaintek Co.,Ltd for the device "OK Handpiece". The FDA issued a decision of Substantially Equivalent on July 15, 2022. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2022
Date Received
June 22, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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FDA data resources