Who else makes this device?

Name: Perio File Sugarman 1S/2S D/E HF Handle
Brand: Perio File Sugarman 1S/2S D/E HF Handle

Perio File Sugarman 1S/2S D/E HF Handle

Catalogue number 40-0400HF, listed by W.H. Holden, Inc., under File, Periodontic. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Shanghai (2), Guangdong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EMR
Manufacturer	City	Province	Registered as	Device types
Sino Ortho Limited	Hangzhou	Zhejiang	Contract manufacturer	14
Shanghai Medical Instruments (Group) Ltd. Corp.	Shanghai	Shanghai	Contract manufacturer	235
Shanghai Kangqiao Dental Instruments Factory	Shanghai	Shanghai	Manufacturer	54
Guangzhou OO Medical Scientific Limited	Guangzhou	Guangdong	Manufacturer	17
Funing Meitedental Factory	Yancheng	Jiangsu	Manufacturer	11

Record

Regulatory record for Perio File Sugarman 1S/2S D/E HF Handle
Listed by	W.H. Holden, Inc.
FDA product code	EMR
Device type	File, Periodontic
Device class	Class 1
Regulation	21 CFR 872.4565
Premarket notification	Exempt
Record published	2026-03-18

Specifications

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

Catalogue Numbers

Catalogue numbers for Perio File Sugarman 1S/2S D/E HF Handle
Catalogue number	Size	Status
40-0400HF		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Nordent Manufacturing Inc	Nordent Manufacturing Inc	66
Kohdent	Kohler Medizintechnik GmbH	48
Hu-Friedy MFG Co., LLC.	HU-Friedy MFG Co., LLC	26
Brasseler USA	Peter Brasseler Holdings, LLC	21
Quinelato	Schobell Industrial Ltda	16
Power Dental USA	Power Dental U.S.A. Inc.	10
Zoll-Dental	Zoll-Dental	10
Sterling	Benco Dental Supply Co.	9
Karl Schumacher	Karl Schumacher Dental, LLC	8
Hu-Friedy	HU-Friedy MFG Co., LLC	8
devemed	Devemed Gmbh	6
Reicodent	Devemed Gmbh	6

Showing 12 of 39. All products under File, 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.