EVOCLEAN CLEANsert Ultrasonic Insert

Scaler, Ultrasonic

TTBIO CORP.

The following data is part of a premarket notification filed by Ttbio Corp. with the FDA for Evoclean Cleansert Ultrasonic Insert.

Pre-market Notification Details

Device IDK210832
510k NumberK210832
Device Name:EVOCLEAN CLEANsert Ultrasonic Insert
ClassificationScaler, Ultrasonic
Applicant TTBIO CORP. 2F, No.7, 6th Road, Industry Park Taichung,  TW 40755
ContactSheng-chieh Su
CorrespondentShu-hui Lin
TTBIO CORP. 2F, No.7, 6th Road, Industry Park Taichung,  TW 40755
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-19
Decision Date2022-02-02

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