Orthometric Bands

Orthodontic Bands KIT- Upper + Welding Tubes Roth 0,022"

Registry build 21.09.26
16manufacturers in China registered for this device type
62catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (4), Shanghai (3), Guangdong (3). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DYO
Manufacturer City Province Registered as Device types
Sino Ortho Limited Hangzhou Zhejiang Contract manufacturer 14
Shanghai Dochem Industries Co., Ltd. Shanghai Shanghai Manufacturer 45
Zhejiang Yamei Medical Equipment Technology Co., Ltd. Yang Jiao Lang Zin’An Town Zhejiang Manufacturer 39
Changsha Nice Medical Instrument Limited Company Changsha Hunan Manufacturer 17
Guangzhou OO Medical Scientific Limited Guangzhou Guangdong Manufacturer 17
Orthguide Medical Technology (Jiangsu) Co., Ltd. Wuxi Jiangsu Contract manufacturer 17
Zhejiang Protect Medical Equipment Co., Ltd. Anji Zhejiang Manufacturer 16
Changsha Easyinsmile Intelligence Technology Co., Ltd. Changsha Hunan Manufacturer 15
Guangzhou Cheer-U Material Technology Co., Ltd. Guangzhou Guangdong Manufacturer 15
Innovative Material & Devices, Inc. Wuxi Jiangsu Contract manufacturer 13
Astar Orthodontics Inc. Shanghai Shanghai Manufacturer 12
Wuhu Guli Ortho Co., Ltd. Wuhu Anhui Contract manufacturer 12

Showing 12 of 16. All 16 manufacturers in China registered for Band, Material, Orthodontic

Record

Regulatory record for Orthometric Bands
Listed by Orthometric – Industria E Comercio DE Produtos Medicos E Odontologicos Ltda
FDA product code DYO
Device type Band, Material, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Premarket notification Exempt
Record published 2022-09-28

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Orthometric Bands
Catalogue number Size Status
40.02.0410 In distribution
40.02.0300 In distribution
40.02.0315 In distribution
40.02.0285 In distribution
40.01.0325 In distribution
40.01.0365 In distribution
40.01.0350 In distribution
40.01.0295 In distribution
40.01.0385 In distribution
40.01.9100 In distribution
40.02.0365 In distribution
40.02.0385 In distribution
40.01.0400 In distribution
40.01.0420 In distribution
40.02.0420 In distribution
40.01.0330 In distribution
40.02.0395 In distribution
40.01.0375 In distribution
40.01.0370 In distribution
40.02.0290 In distribution
40.02.9100 In distribution
40.01.0405 In distribution
40.01.0290 In distribution
40.01.0335 In distribution
40.02.0340 In distribution
40.01.0360 In distribution
40.02.0400 In distribution
40.01.0315 In distribution
40.02.0415 In distribution
40.02.0310 In distribution
40.01.0305 In distribution
40.01.0320 In distribution
40.01.0410 In distribution
40.01.0390 In distribution
40.02.0370 In distribution
40.01.9000 In distribution
40.02.0305 In distribution
40.02.0405 In distribution
40.01.0310 In distribution
40.02.0360 In distribution
40.02.0330 In distribution
40.01.0395 In distribution
40.02.0295 In distribution
40.01.0340 In distribution
40.02.9000 In distribution
40.02.0350 In distribution
40.01.0300 In distribution
40.01.0285 In distribution
40.02.0335 In distribution
40.02.0320 In distribution
40.01.0280 In distribution
40.01.0345 In distribution
40.02.0280 In distribution
40.01.0355 In distribution
40.02.0380 In distribution
40.02.0355 In distribution
40.02.0345 In distribution
40.02.0325 In distribution
40.02.0390 In distribution
40.01.0380 In distribution
40.02.0375 In distribution
40.01.0415 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sure-Snap GC Orthodontics America Inc. 331
Morelli Dental Morelli Ltda. 291
A-FIT® GC Orthodontics America Inc. 264
Bands & Attachments World Class Technology Corporation 133
Legacy GC Orthodontics America Inc. 128
Dental Sheet Sichuan Yaqi Medical Technology Co., Ltd. 96
Ortho-Tain, Inc Ortho-Tain, Inc. 76
3M™ Unitek™ Lingual Sheaths 3M Unitek 21
KGuard Pro Ortho-Tain, Inc. 10
Band, Material, Orthodontic Dentaurum GmbH & Co. KG 8
3M™ Unitek™ 3M Unitek 3
Tofflemire Matrix Bands Thin N°14 Produits dentaires S.A. 1

Showing 12 of 41. All products under Band, Material, Orthodontic

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