Taglus

Taglus .030 x 125mm Round - 125 sheet pk

Registry build 21.09.26
18manufacturers in China registered for this device type
13catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (5), Guangdong (5), Jiangsu (4). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DYT
Manufacturer City Province Registered as Device types
Ningbo Sezen Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 7
Envista (Suzhou) Medical Device Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Envista (Sichuan) Medical Device Co., Ltd. Ziyang Sichuan Contract manufacturer 4
Dongguan Gooodol Mould & Product Co., Ltd. Dongguan Guangdong Contract manufacturer 1
Huanghua Promisee Dental Co., Ltd. Huanghua Hebei Manufacturer 54
Hangzhou Wise Medical Device Co., Ltd. Hangzhou Zhejiang Contract manufacturer 25
Orthguide Medical Technology (Jiangsu) Co., Ltd. Wuxi Jiangsu Contract manufacturer 17
Shenzhen Sunmc Dental Technology Co., Ltd. Shenzhen Guangdong Manufacturer 17
Zhejiang Longmed Medical Technology Co., Ltd. Huzhou Zhejiang Manufacturer 16
Zhejiang Protect Medical Equipment Co., Ltd. Anji Zhejiang Manufacturer 16
Modern Dental Laboratory (DG) Co., Ltd. Dongguan Guangdong Contract manufacturer 15
Hangzhou Westlake Biomaterial Co., Ltd. Hangzhou Zhejiang Contract manufacturer 13

Showing 12 of 18. All 18 manufacturers in China registered for Maintainer, Space Preformed, Orthodontic

Record

Regulatory record for Taglus
Listed by GC Orthodontics America Inc., United States
FDA product code DYT
Device type Maintainer, Space Preformed, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5525
Establishment Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-04-29

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Taglus
Catalogue number Size Per pack Status
GCOA-VS352 2 In distribution
GCOA-VS019 125 In distribution
GCOA-VS353 2 In distribution
GCOA-VS023 45 In distribution
GCOA-VS022 60 In distribution
GCOA-VS284 100 In distribution
GCOA-VS028 100 In distribution
GCOA-VS362 2 In distribution
GCOA-VS012 125 In distribution
GCOA-VS021 100 In distribution
GCOA-VS098 50 In distribution
GCOA-VS280 125 In distribution
GCOA-VS358 2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Denovo chairside space maintainer band Denovo Dental Inc 78
3D RMO 69
Denovo chairside space maintainer crown Denovo Dental Inc 56
e-Space Maintainer Kids-E-Dental LLP 50
Bondable Retainer American Orthodontics 40
NuSmile Ucsm Replacement Band Nusmile, Ltd 39
Vertex-Dental BV Vertex-Dental B.V. 37
Maintainer, Space Preformed, Orthodontic Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. 9
Denovo Space Maintainer wire loop Denovo Dental Inc 8
Reveal® Ortho Organizers, Inc. 8
dentona vivapink Dentona AG 7
Denovo chairside space maintainer band kit Denovo Dental Inc 6

Showing 12 of 114. All products under Maintainer, Space Preformed, 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