Hexa-Temp— 510(k) K214071

Substantially Equivalent

Spident Co., Ltd.

FDA 510(k) clearance K214071 for Hexa-Temp, Substantially Equivalent on 2022-03-10. Applicant: Spident Co., Ltd.. Device class: 2.

Clearance details

Applicant: Spident Co., Ltd.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2021-12-27
Decision date: 2022-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gojan-Dong, Namdong-Gu, KR

Download summary PDF View on FDA.gov ↗

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