Denovo Chairside Space Maintainer Band

Denovo chairside space maintainer band - Mandibular size L26.5

Registry build 21.09.26
18manufacturers in China registered for this device type
78catalogue 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 Denovo chairside space maintainer band
Listed by Denovo Dental Inc, United States
FDA product code DYT
Device type Maintainer, Space Preformed, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5525
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2023-06-26

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Denovo chairside space maintainer band
Catalogue number Size Status
8385-133 In distribution
8385-139 In distribution
8385-237 In distribution
8385-143 In distribution
8385-281 In distribution
8385-165 In distribution
8385-238 In distribution
8385-191 In distribution
8385-171 In distribution
8385-275 In distribution
8385-233 In distribution
8385-145 In distribution
8385-245 In distribution
8385-240 In distribution
8385-265 In distribution
8385-261 In distribution
8385-138 In distribution
8385-263 In distribution
8385-131 In distribution
8385-293 In distribution
8385-155 In distribution
8385-140 In distribution
8385-232 In distribution
8385-234 In distribution
8385-271 In distribution
8385-189 In distribution
8385-134 In distribution
8385-137 In distribution
8385-173 In distribution
8385-251 In distribution
8385-167 In distribution
8385-151 In distribution
8385-187 In distribution
8385-236 In distribution
8385-277 In distribution
8385-259 In distribution
8385-163 In distribution
8385-159 In distribution
8385-295 In distribution
8385-175 In distribution
8385-197 In distribution
8385-153 In distribution
8385-289 In distribution
8385-169 In distribution
8385-257 In distribution
8385-185 In distribution
8385-273 In distribution
8385-243 In distribution
8385-231 In distribution
8385-179 In distribution
8385-147 In distribution
8385-287 In distribution
8385-283 In distribution
8385-177 In distribution
8385-247 In distribution
8385-141 In distribution
8385-149 In distribution
8385-239 In distribution
8385-132 In distribution
8385-267 In distribution
8385-235 In distribution
8385-279 In distribution
8385-136 In distribution
8385-285 In distribution
8385-193 In distribution
8385-195 In distribution
8385-291 In distribution
8385-269 In distribution
8385-297 In distribution
8385-181 In distribution
8385-135 In distribution
8385-161 In distribution
8385-157 In distribution
8385-241 In distribution
8385-183 In distribution
8385-249 In distribution
8385-253 In distribution
8385-255 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
Taglus GC Orthodontics America Inc. 13
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