Comfort-Sonic

Woodpecker: GK7 , Gentle pocket cleansing during periodontal treatment; effective cleansing in pockets up to 9 mm deep; from second/fourth quadrant to central incisor accessed buccally,…

Registry build 21.09.26

Woodpecker: GK7 , Gentle pocket cleansing during periodontal treatment; effective cleansing in pockets up to 9 mm deep; from second/fourth quadrant to central incisor accessed buccally, then cleansing of front teeth, premolars and molars of the first/third quadrant, accessed palatally/lingually

14manufacturers in China registered for this device type
19catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (4), Guangxi (4), Shandong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ELC
Manufacturer City Province Registered as Device types
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
China Zhong YAN Chang Xing International Co., Ltd. Zibo Shandong Contract manufacturer 5
Lakong Medical Devices Co., Ltd. Dongguan Guangdong Remanufacturer 39
Guilin Woodpecker Medical Instrument Co., Ltd. Guilin Guangxi Manufacturer 25
Foshan Coxo Medical Instrument Co., Ltd. Foshan Guangdong Manufacturer 19
Denjoy Dental Co., Ltd. Changsha Hunan Contract manufacturer 17
Wenzhou Baiyu Glasses Technology Co., Ltd. Wenzhou Zhejiang Contract manufacturer 10
Shenzhen Ainengke Electronics Co., Ltd. Shenzhen Guangdong Manufacturer 9
Guilin Refine Medical Instrument Co., Ltd. Guilin Guangxi Contract manufacturer 7
Shenzhen Micro Electric Intelligence Co., Ltd. Shenzhen Guangdong Manufacturer 7
Changzhou Bomedent Medical Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 6
Nanning Baolai Medical Instrument Co., Ltd. Nanning Guangxi Manufacturer 4

Showing 12 of 14. All 14 manufacturers in China registered for Scaler, Ultrasonic

Record

Regulatory record for Comfort-Sonic
Listed by Beyes Dental Canada, Inc., United States
FDA product code ELC
Device type Scaler, Ultrasonic
Device class Class 2
Regulation 21 CFR 872.4850
510(k) K053555
Record published 2023-05-11

Specifications

Specifications
MRI safety MR Safe
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Comfort-Sonic
Catalogue number Size Status
UL2104 In distribution
UL2211 In distribution
UL2210 In distribution
UL2218 In distribution
UL3300 In distribution
UL2214 In distribution
UL2215 In distribution
UL2216 In distribution
UL2103 In distribution
UL3300 In distribution
UL2220 In distribution
UL2103 In distribution
UL2221 In distribution
UL2104 In distribution
UL2212 In distribution
UL2219 In distribution
UL2213 In distribution
UL2222 In distribution
UL2217 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Woodpecker Guilin Woodpecker Medical Instrument Co., Ltd. 501
Piezon E.M.S. Electro Medical Systems S.A. 245
Acteon Satelec 236
Mectron Mectron SPA 209
Varios Nakanishi Inc. 158
BioSonic Coltene/Whaledent Gmbh & Co. KG 142
Cavitron® Dentsply Professional 137
DTE Guilin Woodpecker Medical Instrument Co., Ltd. 113
Hu-Friedy HU-Friedy MFG Co., LLC 83
Obtura Spartan Obtura Spartan Endodontics 74
Henry Schein Henry Schein, Inc. 48
Baolai Nanning Baolai Medical Instrument Co., Ltd. 46

Showing 12 of 653. All products under Scaler, Ultrasonic

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer