Devemed

Scaler-File # BL1 Buccal/Lingual; with diamond coating F-LINE | SL | double ended

Registry build 21.09.26
34manufacturers in China registered for this device type
35catalogue 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 devemed
Listed by Devemed Gmbh, Germany
FDA product code EMN
Device type Scaler, Periodontic
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2020-03-30

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for devemed
Catalogue number Size Status
JQM 2-3 F In distribution
ZRM MI1 F In distribution
ZRK RWH F In distribution
CTM 104-105 F In distribution
GFM 1 F In distribution
CKM 6 F In distribution
MFM 2-3 F In distribution
HJM H5-33 F In distribution
ZRM 204SD F In distribution
ZFM MD1 F In distribution
MCM 11A-12A F In distribution
TJM U15-30 F In distribution
GFM 21 F In distribution
ZRM M-23 F In distribution
ZRM 204S F In distribution
MCM 11-12 F In distribution
HYM H6-H7 F In distribution
MCM 13S-14S F In distribution
TAM T2-T3 F In distribution
ZRM 204 F In distribution
JQM 31-32 F In distribution
HTM H5-U15 F In distribution
ZRM N5-48 F In distribution
ZFM BL1 F In distribution
ZRM CI2-3 F In distribution
JQM 30-33 F In distribution
TJM U15-33 F In distribution
MFM 4-5 F In distribution
MCM 13-14 F In distribution
CTM 107-108 F In distribution
HOM 156-577 F In distribution
JQS 34-35 F In distribution
JQM 2S-3S F In distribution
SPM 23 F In distribution
DPM 5K-6K F 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
Hu-Friedy HU-Friedy MFG Co., LLC 207
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

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