Morelli

Anatomic Band L/LR 37,5mm With Tubes 20.10.411 / 412 and 20.61.206

Registry build 21.09.26
16manufacturers in China registered for this device type
291catalogue 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 Morelli
Listed by Dental Morelli Ltda., Brazil
FDA product code DYO
Device type Band, Material, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Manufacturer
Premarket notification Exempt
Record published 2021-04-30
Record revised 2024-05-30 (version 3)

Specifications

Specifications
MRI safety MR Conditional
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Morelli
Catalogue number Size Status
40.02.415 In distribution
47.21.018 In distribution
40.12.375 In distribution
48.31.121 In distribution
40.91.004 In distribution
47.31.013 In distribution
47.21.016 In distribution
47.31.026 In distribution
48.31.123 In distribution
40.22.345 In distribution
47.11.013 In distribution
40.01.405 In distribution
40.02.380 In distribution
47.21.115 In distribution
40.22.410 In distribution
40.91.003 In distribution
40.02.350 In distribution
40.02.405 In distribution
47.31.016 In distribution
40.02.280 In distribution
40.01.901 In distribution
48.20.118 In distribution
40.02.315 In distribution
47.31.010 In distribution
40.12.335 In distribution
40.22.290 In distribution
47.11.019 In distribution
47.20.014 In distribution
40.50.027 In distribution
48.31.111 In distribution
47.20.314 In distribution
40.01.280 In distribution
48.20.117 In distribution
40.01.325 In distribution
40.02.325 In distribution
47.20.015 In distribution
40.22.330 In distribution
47.21.120 In distribution
40.02.335 In distribution
40.50.013 In distribution
40.01.290 In distribution
47.20.315 In distribution
47.10.008 In distribution
47.21.113 In distribution
47.31.014 In distribution
48.31.116 In distribution
40.22.415 In distribution
47.10.015 In distribution
47.21.015 In distribution
47.11.022 In distribution
40.01.420 In distribution
40.22.295 In distribution
40.22.300 In distribution
47.10.016 In distribution
48.20.120 In distribution
47.11.008 In distribution
40.02.901 In distribution
40.01.335 In distribution
47.10.007 In distribution
40.50.030 In distribution
47.20.024 In distribution
40.12.420 In distribution
47.10.023 In distribution
47.21.017 In distribution
40.01.380 In distribution
47.20.023 In distribution
47.11.023 In distribution
47.20.011 In distribution
40.01.900 In distribution
40.22.405 In distribution
47.31.020 In distribution
40.01.390 In distribution
40.22.370 In distribution
48.31.120 In distribution
48.31.124 In distribution
40.12.300 In distribution
47.21.013 In distribution
40.01.320 In distribution
40.50.018 In distribution
47.20.027 In distribution
40.50.026 In distribution
40.12.340 In distribution
47.20.112 In distribution
40.22.305 In distribution
47.31.023 In distribution
40.22.420 In distribution
47.31.022 In distribution
48.31.118 In distribution
47.21.021 In distribution
40.01.360 In distribution
40.22.310 In distribution
40.02.400 In distribution
47.31.019 In distribution
40.12.395 In distribution
47.21.118 In distribution
47.31.011 In distribution
47.20.118 In distribution
40.12.410 In distribution
47.21.116 In distribution
40.02.345 In distribution
47.20.007 In distribution
47.20.120 In distribution
47.20.113 In distribution
47.20.010 In distribution
40.02.395 In distribution
47.31.017 In distribution
48.31.119 In distribution
40.12.365 In distribution
47.10.022 In distribution
47.20.020 In distribution
40.91.002 In distribution
40.22.335 In distribution
47.20.319 In distribution
40.22.340 In distribution
40.50.014 In distribution
40.50.024 In distribution
40.22.355 In distribution
40.22.360 In distribution
40.22.315 In distribution
47.10.010 In distribution
47.11.020 In distribution
40.12.325 In distribution
40.50.016 In distribution
47.20.116 In distribution
47.10.021 In distribution
40.12.370 In distribution
40.12.415 In distribution
48.31.122 In distribution
40.01.295 In distribution
47.31.015 In distribution
40.22.375 In distribution
40.12.360 In distribution
47.11.021 In distribution
47.21.121 In distribution
40.02.300 In distribution
40.01.355 In distribution
47.10.013 In distribution
40.12.345 In distribution
47.20.318 In distribution
47.11.007 In distribution
40.02.340 In distribution
47.20.025 In distribution
40.22.400 In distribution
47.31.027 In distribution
47.21.020 In distribution
40.22.365 In distribution
40.50.021 In distribution
47.10.009 In distribution
47.21.012 In distribution
48.20.119 In distribution
40.01.345 In distribution
40.50.029 In distribution
40.50.019 In distribution
47.21.111 In distribution
40.02.365 In distribution
40.22.395 In distribution
40.22.350 In distribution
48.31.117 In distribution
48.20.112 In distribution
40.01.315 In distribution
40.01.385 In distribution
47.31.018 In distribution
47.20.026 In distribution
40.01.395 In distribution
48.20.114 In distribution
40.01.365 In distribution
48.31.115 In distribution
48.31.126 In distribution
47.10.024 In distribution
47.10.012 In distribution
40.12.380 In distribution
40.12.320 In distribution
47.10.014 In distribution
40.50.022 In distribution
47.10.011 In distribution
40.01.370 In distribution
40.02.375 In distribution
40.50.025 In distribution
48.31.127 In distribution
40.02.355 In distribution
47.20.021 In distribution
40.02.385 In distribution
40.02.390 In distribution
40.22.385 In distribution
47.20.313 In distribution
40.02.330 In distribution
47.31.025 In distribution
47.11.009 In distribution
40.01.375 In distribution
40.12.315 In distribution
47.11.025 In distribution
47.11.016 In distribution
47.20.009 In distribution
47.10.027 In distribution
47.20.115 In distribution
40.12.350 In distribution
47.11.011 In distribution
47.21.114 In distribution
48.31.110 In distribution
47.21.019 In distribution
47.10.025 In distribution
48.31.112 In distribution
48.20.116 In distribution
40.50.032 In distribution
48.31.114 In distribution
40.12.295 In distribution
40.02.320 In distribution
40.50.015 In distribution
40.01.415 In distribution
47.20.013 In distribution
47.11.012 In distribution
47.31.009 In distribution
47.20.022 In distribution
40.12.390 In distribution
47.11.014 In distribution
40.01.410 In distribution
47.20.016 In distribution
47.10.017 In distribution
47.20.018 In distribution
40.02.290 In distribution
47.20.008 In distribution
40.91.001 In distribution
47.20.320 In distribution
47.31.021 In distribution
47.21.117 In distribution
47.11.024 In distribution
47.20.117 In distribution
40.12.290 In distribution
40.12.305 In distribution
47.11.026 In distribution
47.21.119 In distribution
47.20.317 In distribution
40.22.390 In distribution
40.02.310 In distribution
40.12.385 In distribution
47.11.010 In distribution
40.02.900 In distribution
40.01.300 In distribution
40.02.420 In distribution
40.22.325 In distribution
47.10.026 In distribution
40.02.295 In distribution
40.01.350 In distribution
40.50.012 In distribution
40.22.380 In distribution
40.50.017 In distribution
40.12.355 In distribution
40.02.410 In distribution
47.11.018 In distribution
47.20.017 In distribution

Showing 250 of 291 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sure-Snap GC Orthodontics America Inc. 331
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
Orthometric Bands Orthometric – Industria E Comercio DE Produtos Medicos E Odontologicos Ltda 62
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