Rollo Bands

Band Rollo LL 1ST Molar SZ 30 W/16.5MM Cantilever Flat NUT Tube 022

Registry build 21.09.26
27manufacturers in China registered for this device type
660catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (17), Jiangsu (4), Guangdong (4). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ECM
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Hangzhou Westlake Biomaterial Co., Ltd. Hangzhou Zhejiang Contract manufacturer 13
Zhejiang Eksen Medical Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 9
Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7
Yancheng Denrum Medical Apparatus Co., Ltd. Yancheng Jiangsu Contract manufacturer 5
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Zhejiang Yamei Medical Equipment Technology Co., Ltd. Yang Jiao Lang Zin’An Town Zhejiang Manufacturer 39
Hangzhou Wise Medical Device Co., Ltd. Hangzhou Zhejiang Contract manufacturer 25
Guangzhou OO Medical Scientific Limited Guangzhou Guangdong Manufacturer 17
Orthguide Medical Technology (Jiangsu) Co., Ltd. Wuxi Jiangsu Contract manufacturer 17

Showing 12 of 27. All 27 manufacturers in China registered for Band, Preformed, Orthodontic

Record

Regulatory record for Rollo Bands
Listed by American Orthodontics, United States
FDA product code ECM
Device type Band, Preformed, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2020-01-22
Record revised 2025-07-25 (version 5)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Distribution end date 2025-07-24

Catalogue Numbers

Catalogue numbers for Rollo Bands
Catalogue number Size Status
141218T-0R-1500 In distribution
153303N-0R-3000 In distribution
154300N-0L-2400 In distribution
142202H-0L-2400 In distribution
154303NT-0L-0600 In distribution
142222F-0L-3000 In distribution
153299N-0R-2700 In distribution
154299-0L-1500 In distribution
153301-0R-2100 In distribution
153304NT-0R-2100 In distribution
154300NT-0L-3000 In distribution
142202-0L-1800 In distribution
141202-0R-3300 In distribution
153302NT-0R-3000 In distribution
142000-1L-1200 In distribution
142000-1L-1800 In distribution
141222T-0R-1200 In distribution
154301-0L-2400 In distribution
142201AH-0L-1500 In distribution
154301-0L-0600 In distribution
153301-0R-3300 In distribution
154300N-0L-2100 In distribution
153303-0R-0600 In distribution
154303-0L-1500 In distribution
153301NT-0R-3000 In distribution
142202H-0L-2100 In distribution
142201A-0L-0600 In distribution
153302NT-0R-1800 In distribution
141202H-0R-1800 In distribution
154302NT-0L-1800 In distribution
141000-1R-0600 In distribution
153300N-0R-0600 In distribution
154304-0L-3300 In distribution
141201-0R-2100 In distribution
154304-0L-2700 In distribution
153302-0R-0900 In distribution
154304NT-0L-3000 In distribution
153301N-0R-3300 In distribution
154301N-0L-2700 In distribution
142201A-0L-0900 In distribution
154300N-0L-1800 In distribution
141000-1R-2400 In distribution
141218T-0R-1800 In distribution
153000-0R-2400 In distribution
153303-0R-3000 In distribution
141202-0R-2100 In distribution
153303NT-0R-1500 In distribution
142202-0L-0600 In distribution
153300NT-0R-1500 In distribution
154000-0L-2700 In distribution
153303N-0R-1800 In distribution
142222F-0L-1500 In distribution
142222F-0L-1200 In distribution
154299-0L-3300 In distribution
141000-0R-0900 In distribution
154299N-0L-2400 In distribution
142222F-0L-2100 In distribution
141222T-0R-2100 In distribution
153299-0R-3300 In distribution
153301-0R-2400 In distribution
141201A-0R-3300 In distribution
141202H-0R-2100 In distribution
153304N-0R-2700 In distribution
141202-0R-2400 In distribution
141202-0R-3000 In distribution
153301NT-0R-1800 In distribution
154304N-0L-1200 In distribution
154303-0L-0600 In distribution
154299-0L-1200 In distribution
141202H-0R-2400 In distribution
141201AH-0R-1200 In distribution
153304N-0R-2400 In distribution
141200-0R-2700 In distribution
153304-0R-0900 In distribution
154299-0L-2700 In distribution
153299-0R-1500 In distribution
142000-0L-0600 In distribution
154303NT-0L-0900 In distribution
141000-0R-1500 In distribution
154302NT-0L-1200 In distribution
142201AH-0L-3000 In distribution
142202-0L-2100 In distribution
141200-0R-2100 In distribution
154000-0L-3000 In distribution
154299N-0L-0900 In distribution
142201-0L-3300 In distribution
154301-0L-2700 In distribution
141218T-0R-3000 In distribution
154304-0L-2100 In distribution
141201A-0R-0600 In distribution
141000-1R-2100 In distribution
142218T-0L-1800 In distribution
153303NT-0R-0900 In distribution
153000-1R-3300 In distribution
154300NT-0L-2100 In distribution
142201H-0L-2400 In distribution
153302NT-0R-2400 In distribution
153301-0R-1800 In distribution
154300-0L-2400 In distribution
142201-0L-1800 In distribution
142201A-0L-2400 In distribution
154300-0L-2700 In distribution
154299N-0L-3300 In distribution
141201-0R-2700 In distribution
153304N-0R-0900 In distribution
142222T-0L-1200 In distribution
153302-0R-2400 In distribution
141201H-0R-0900 In distribution
154303-0L-3300 In distribution
154301-0L-0900 In distribution
153299N-0R-1500 In distribution
153301N-0R-1800 In distribution
154301N-0L-1200 In distribution
154303-0L-0900 In distribution
141222T-0R-0600 In distribution
141222F-0R-3300 In distribution
154000-1L-3000 In distribution
154303N-0L-3000 In distribution
154000-0L-1500 In distribution
153299-0R-1800 In distribution
154300NT-0L-1200 In distribution
141202H-0R-1500 In distribution
154304N-0L-2700 In distribution
141202H-0R-1200 In distribution
142222F-0L-0600 In distribution
141200-0R-1500 In distribution
141000-1R-1500 In distribution
153300N-0R-2700 In distribution
154303N-0L-1800 In distribution
153303NT-0R-3000 In distribution
154303NT-0L-2400 In distribution
154299-0L-3000 In distribution
142200-0L-3000 In distribution
153301N-0R-2100 In distribution
142000-1L-1500 In distribution
142201AH-0L-0600 In distribution
154303NT-0L-3000 In distribution
153301NT-0R-2400 In distribution
142218T-0L-1500 In distribution
153300NT-0R-2400 In distribution
142201-0L-0600 In distribution
153300N-0R-3300 In distribution
141201A-0R-2700 In distribution
142222T-0L-3300 In distribution
141202H-0R-3300 In distribution
142201H-0L-3000 In distribution
153300NT-0R-0600 In distribution
154300N-0L-3000 In distribution
154301N-0L-2100 In distribution
154302NT-0L-2400 In distribution
154301NT-0L-2400 In distribution
154303-0L-2700 In distribution
141201H-0R-0600 In distribution
153303-0R-2100 In distribution
154300-0L-1800 In distribution
153301N-0R-1200 In distribution
153301-0R-0600 In distribution
154303NT-0L-2700 In distribution
142222T-0L-2700 In distribution
153302NT-0R-2700 In distribution
142201H-0L-3300 In distribution
153299N-0R-0600 In distribution
153302-0R-3300 In distribution
141218T-0R-2100 In distribution
154301N-0L-3000 In distribution
141201AH-0R-2100 In distribution
153300N-0R-2400 In distribution
154303NT-0L-2100 In distribution
153300N-0R-1500 In distribution
153300-0R-3000 In distribution
153303-0R-2400 In distribution
154301NT-0L-3000 In distribution
141201AH-0R-2700 In distribution
142222T-0L-2100 In distribution
141000-0R-3000 In distribution
153301NT-0R-1200 In distribution
154300-0L-3300 In distribution
141222T-0R-2400 In distribution
154304N-0L-3000 In distribution
142000-1L-2700 In distribution
154301-0L-3300 In distribution
154304-0L-3000 In distribution
153300N-0R-1200 In distribution
142222T-0L-0900 In distribution
142222F-0L-2700 In distribution
154303NT-0L-1200 In distribution
153299N-0R-3000 In distribution
153299-0R-2400 In distribution
153302-0R-2100 In distribution
142201AH-0L-0900 In distribution
154000-1L-2400 In distribution
153299-0R-2100 In distribution
153000-1R-2100 In distribution
141218T-0R-3300 In distribution
154304NT-0L-1200 In distribution
141000-0R-0600 In distribution
154300NT-0L-0900 In distribution
141201AH-0R-0600 In distribution
153301-0R-3000 In distribution
154303N-0L-0900 In distribution
153299N-0R-2100 In distribution
153301NT-0R-2100 In distribution
153301-0R-1500 In distribution
153304-0R-1200 In distribution
153303-0R-0900 In distribution
154302NT-0L-3300 In distribution
154303NT-0L-1500 In distribution
154304-0L-0600 In distribution
154304N-0L-1800 In distribution
154303NT-0L-3300 In distribution
141222F-0R-1800 In distribution
154300-0L-0900 In distribution
141218T-0R-0600 In distribution
153304-0R-1500 In distribution
153304NT-0R-2700 In distribution
142202H-0L-2700 In distribution
141201AH-0R-0900 In distribution
142201A-0L-1500 In distribution
154304NT-0L-1800 In distribution
142222F-0L-2400 In distribution
153300-0R-1500 In distribution
153304N-0R-2100 In distribution
154304N-0L-1500 In distribution
141222T-0R-2700 In distribution
154300N-0L-2700 In distribution
154000-1L-1500 In distribution
141201A-0R-2400 In distribution
142222F-0L-1800 In distribution
142000-1L-2400 In distribution
153300N-0R-2100 In distribution
153301NT-0R-3300 In distribution
141201A-0R-1800 In distribution
154304N-0L-2400 In distribution
153299-0R-3000 In distribution
141201H-0R-2400 In distribution
154000-0L-2400 In distribution
154302-0L-2100 In distribution
141202-0R-0600 In distribution
141000-0R-3300 In distribution
142202-0L-3000 In distribution
154302-0L-1800 In distribution
142201A-0L-3000 In distribution
142202H-0L-3000 In distribution
154302NT-0L-1500 In distribution
154300NT-0L-1800 In distribution
141202-0R-0900 In distribution
153299-0R-1200 In distribution
141202H-0R-3000 In distribution
142201H-0L-2700 In distribution
141200-0R-2400 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Band, Preformed, Orthodontic Forestadent Bernhard Förster GmbH 8,646
TruFit 2.0 Ortho Technology, Inc. 4,890
TruFit™ Ortho Organizers, Inc. 3,943
Leone SPA Leone SPA 2,549
dentaform® Dentaurum GmbH & Co. KG 1,763
Band Assemblies Ortho Organizers, Inc. 1,642
3M™ Victory Series™ 3M Unitek 1,388
The Orthodontic Store Young Innovations Inc. 925
Elite® Band Assemblies Ortho Organizers, Inc. 924
TruFit™ 2.0 Ortho Organizers, Inc. 916
3M™ Unitek™ 3M Unitek 771
Elite Ortho Organizers, Inc. 722

Showing 12 of 154. All products under Band, 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