Dental Scaler And Air Polisher

Scaler, Ultrasonic

Guilin Woodpecker Medical Instrument Co., Ltd.

The following data is part of a premarket notification filed by Guilin Woodpecker Medical Instrument Co., Ltd. with the FDA for Dental Scaler And Air Polisher.

Pre-market Notification Details

Device IDK203615
510k NumberK203615
Device Name:Dental Scaler And Air Polisher
ClassificationScaler, Ultrasonic
Applicant Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone Guilin,  CN 541004
ContactYiwei Wang
CorrespondentSonya Lai
Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen,  CN 518000
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-10
Decision Date2021-12-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944843655024 K203615 000
06944843616872 K203615 000
06944843655987 K203615 000
06944843611617 K203615 000
06944843611600 K203615 000
06944843611594 K203615 000
06944843611587 K203615 000

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