Hu-Friedy

#15/16 Gracey Curette,EE2, Harmony,Orange

Registry build 21.09.26
34manufacturers in China registered for this device type
207catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (15), Shandong (5), Shanghai (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EMN
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
Yangzhou Haiwang Toothbrush Factory Yangzhou Jiangsu Contract manufacturer 12
Coda Resources Ltd., Heze China Heze Shandong Contract manufacturer 9
Perfect Group Corp. Ltd. Yangzhou Jiangsu Contract manufacturer 9
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Lakong Medical Devices Co., Ltd. Dongguan Guangdong Remanufacturer 39
Tangshan Zhengtong Exhibition Co., Ltd. Tangshan Hebei Manufacturer 34
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28
Shenzhen Balinda Technology Co., Ltd. Shenzhen Guangdong Manufacturer 23

Showing 12 of 34. All 34 manufacturers in China registered for Scaler, Periodontic

Record

Regulatory record for Hu-Friedy
Listed by HU-Friedy MFG Co., LLC, United States
FDA product code EMN
Device type Scaler, Periodontic
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2021-03-02
Record revised 2022-01-12 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Over the counter Yes
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Hu-Friedy
Catalogue number Size Status
SAS11/14XE2 In distribution
SG17/18XE2 In distribution
SYG7/8XE2 In distribution
LP00856 In distribution
SAS13/14XCE2 In distribution
SAS5/6XCE2 In distribution
SAS1/2RXE2 In distribution
SC4R/4LC9YE2 In distribution
SBH5/6RXE2 In distribution
DSBH5/6 In distribution
Kit-1A-Comp In distribution
SG5/6RXCE2 In distribution
SRPG12/13XE2 In distribution
SAS11/12XCE2 In distribution
SYG15/ODONT1 In distribution
SAS7/8RXCE2 In distribution
SRP1/2RXCE2 In distribution
SU15/30G9E2 In distribution
SAS12/13XE2 In distribution
DSG15/166 In distribution
SRP5/6RXE2 In distribution
SG5/6XCE2 In distribution
SAS3/4RXE2 In distribution
SH6/7G9E2 In distribution
SRPG5/6XCE2 In distribution
Kit-2A-Perio In distribution
SC4R/4LXE2 In distribution
SRPG1/2XE2 In distribution
SRPG13/14G9E2 In distribution
DSG17/186 In distribution
SBH1/2USCXE2 In distribution
SG9/10XE2 In distribution
SRPG11/12G9E2 In distribution
SRP15/16RXCE2 In distribution
SAS15/16G9E2 In distribution
SH5/S446 In distribution
SG1/2XCE2 In distribution
SU15/30XE2 In distribution
SBH1/2RXE2 In distribution
SG12/13XE2 In distribution
SRPG7/8XCE2 In distribution
SC6688XE2 In distribution
SRP11/12RG9E2 In distribution
SL5/6XE2 In distribution
SG17/18XCE2 In distribution
S204SXE2 In distribution
SG15/16RXCE2 In distribution
S204SDG9E2 In distribution
SG13/14XCE2 In distribution
SN128DEG9E2 In distribution
SAS17/18XCE2 In distribution
SJ34/35XE2 In distribution
SG7/8RXCE2 In distribution
SC13/14XE2 In distribution
SMS7/8XE2 In distribution
SCNEVI4G9E2 In distribution
S204SDXE2 In distribution
SBH5/6XE2 In distribution
SAS11/12G9E2 In distribution
SRP15/16RXE2 In distribution
SH5/33G9E2 In distribution
SAS13/14G9E2 In distribution
SG11/14XE2 In distribution
SN135XE2 In distribution
SG15/16XCE2 In distribution
SN135G9E2 In distribution
SH6/7C9YE2 In distribution
SRPG3/4XE2 In distribution
SN128DEXE2 In distribution
SM13/14XE2 In distribution
SG17/18RXE2 In distribution
SCNEVI1G9E2 In distribution
SRPG11/12XCE2 In distribution
SAS1/2RXCE2 In distribution
SRP7/8RXCE2 In distribution
SM17/18XE2 In distribution
IMPM11/12T In distribution
SG13/14RXCE2 In distribution
SBH1/2RG9E2 In distribution
SAS7/8XCE2 In distribution
IMP204SDT In distribution
SMS1/2XE2 In distribution
SG7/8XCE2 In distribution
SN128/NEV19E2 In distribution
SL1/2XE2 In distribution
SG1/2XE2 In distribution
SG13/14XE2 In distribution
SM0/00G9E2 In distribution
SC6687XE2 In distribution
S204SC9YE2 In distribution
SAS15/16XE2 In distribution
SCNEVI3XE2 In distribution
SAS11/12RXE2 In distribution
SBH5/6USCXE2 In distribution
SRPG15/16XE2 In distribution
SMS13/14XCE2 In distribution
SH5/33XE2 In distribution
SG5/6XE2 In distribution
SG1/2RXE2 In distribution
SM0/00XE2 In distribution
SG11/12C9YE2 In distribution
SRPG13/14XCE2 In distribution
SL3/4XE2 In distribution
SRPG1/2XCE2 In distribution
SAS13/14RXCE2 In distribution
DSCNEVI16 In distribution
SU15/33G9E2 In distribution
SAS3/4XE2 In distribution
SG3/4XE2 In distribution
SC2R/2LXE2 In distribution
SRP3/4RXE2 In distribution
SG13/14RC9YE2 In distribution
SG7/8XE2 In distribution
SCNEVI2XE2 In distribution
SC6690XE2 In distribution
SRPG1/2G9E2 In distribution
SCNEVI4RT9E2 In distribution
SH5/S456 In distribution
SCNEVI2G9E2 In distribution
SAS5/6RXE2 In distribution
SAS15/16RXE2 In distribution
SMS13/14XE2 In distribution
SJ31/32XE2 In distribution
SM23XE2 In distribution
SAS15/16XCE2 In distribution
SG11/12RC9YE2 In distribution
SAS1/2XCE2 In distribution
SRPG15/16XCE2 In distribution
SL17/18XE2 In distribution
DSC13/146 In distribution
SRPG11/14XE2 In distribution
SAS7/8XE2 In distribution
SG17/18RXCE2 In distribution
SAS15/16RXCE2 In distribution
SMS11/12XE2 In distribution
SG15/16RXE2 In distribution
SRP11/12RXCE2 In distribution
SRPG15/16G9E2 In distribution
SM17/18G9E2 In distribution
SG9/10RXCE2 In distribution
SRP5/6RXCE2 In distribution
SRP13/14RXE2 In distribution
SAS13/14XE2 In distribution
SCNEVI4LG9E2 In distribution
SAS5/6XE2 In distribution
SAS11/12RXCE2 In distribution
SCNEVI1XE2 In distribution
SAS1/2XE2 In distribution
SAS11/12XE2 In distribution
SG5/6RXE2 In distribution
SAS13/14RXE2 In distribution
SRP7/8RXE2 In distribution
SRP1/2RG9E2 In distribution
SG11/12XCE2 In distribution
SRPG7/8XE2 In distribution
SCNEVI3G9E2 In distribution
IMPM13/14T In distribution
SRP13/14RG9E2 In distribution
SAS7/8RXE2 In distribution
SMS11/12XCE2 In distribution
IMPM1/2T In distribution
SMS7/8XCE2 In distribution
SM13/14SXE2 In distribution
SAS1/2G9E2 In distribution
SRPG5/6XE2 In distribution
SIUFW204XE2 In distribution
SBH1/2XE2 In distribution
SG11/12RXE2 In distribution
SRP11/12RXE2 In distribution
SC13/14C9YE2 In distribution
SCNEVI4LXE2 In distribution
SG9/10RXE2 In distribution
SAS5/6RXCE2 In distribution
SN137XE2 In distribution
SG11/12XE2 In distribution
SJ30/33XE2 In distribution
SG13/14RXE2 In distribution
DS2046 In distribution
SAS17/18XE2 In distribution
IMPLG1/2T In distribution
SH6/7XE2 In distribution
SM13/14SG9E2 In distribution
SCNEVI4C9YE2 In distribution
SG3/4XCE2 In distribution
SG3/4RXE2 In distribution
SG9/10XCE2 In distribution
SG11/12RXCE2 In distribution
SNEV1/H5XE2 In distribution
SG1/2RC9YE2 In distribution
S204SG9E2 In distribution
SNEV1/H5G9E2 In distribution
DSG11/126 In distribution
DSBH5/66 In distribution
SG7/8RXE2 In distribution
SG3/4RXCE2 In distribution
SUCR3/4XE2 In distribution
SCNEVI4XE2 In distribution
SRPG11/12XE2 In distribution
SC6689XE2 In distribution
SG15/16XE2 In distribution
SMS1/2XCE2 In distribution
SRP1/2RXE2 In distribution
SRPG13/14XE2 In distribution
SRP13/14RXCE2 In distribution
SBH5/6RG9E2 In distribution
SG1/2RXCE2 In distribution
SU15/33XE2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hu-Friedy MFG Co., LLC. HU-Friedy MFG Co., LLC 468
American Eagle Instruments American Eagle Instruments 269
Zoll-Dental Zoll-Dental 255
Power Dental USA Power Dental U.S.A. Inc. 202
Osung MND Osung MND Co., Ltd. 102
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 85
Sklar® Sklar Corporation 81
Henry Schein Henry Schein, Inc. 79
Integra® Miltex® Integra LifeSciences Production Corporation 77
PDT, Inc. PDT, Inc. 67
House Brand Dentistry Frontier Dental Supply Inc 65
J & J Instruments J & J Instruments, LLC 56

Showing 12 of 216. All products under Scaler, Periodontic

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