Neodent

Sinus Lift Curette N. 1

Registry build 21.09.26
4manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Shandong (1), Guangxi (1).

Chinese manufacturers registered for FDA product code EMK
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28
Hangzhou Haizhu MIM Products Co., Ltd. Hangzhou Zhejiang Exporter 28

Record

Regulatory record for Neodent
Listed by Jjgc Indústria e Comércio de Materiais Dentários S.A., Brazil
FDA product code EMK
Device type Curette, Surgical, Dental
Device class Class 1
Regulation 21 CFR 872.4565
Premarket notification Exempt
Record published 2022-12-13
Record revised 2023-12-21 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature up to 40 °C; Special storage condition: Protect from Sunlight

Catalogue Numbers

Catalogue numbers for Neodent
Catalogue number Size Status
126.008 In distribution
126.012 In distribution
126.009 In distribution
126.011 In distribution
126.010 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surgical Direct Surgical Direct, Inc. 693
A. Titan Instruments A. Titan Instruments, Inc. 170
HU-Friedy HU-Friedy MFG Co., LLC 112
Nordent Manufacturing Inc Nordent Manufacturing Inc 85
Schwert A. Schweickhardt Gmbh & Co. KG 72
Paul Banditt Terlain Enterprises, Inc. 52
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 45
Sklar® Sklar Corporation 40
Anatomic Colours Aesculap AG 39
Zoll-Dental Zoll-Dental 39
Aesculap Aesculap AG 39
devemed Devemed Gmbh 33

Showing 12 of 107. All products under Curette, Surgical, Dental

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