TruFit™
TruFit™ 2.0 ASM .018 ROTH UR6 CONV OCBT -10T 10DOff CLT 35.0 (3PK)
27manufacturers in China registered for this device type
3,943catalogue 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.
| 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
| Listed by | Ortho Organizers, Inc., United States |
|---|---|
| FDA product code | ECM |
| Device type | Band, Preformed, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-10-01 |
| Record revised | 2025-12-30 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 491-12-2620-355-3 | 3 | In distribution | |
| 493-22-2652-350-3 | 3 | In distribution | |
| 493-22-3720-320-3 | 3 | In distribution | |
| 493-21-2671-305-3 | 3 | In distribution | |
| 493-91-3720-415-3 | 3 | In distribution | |
| 493-91-3691-385-3 | 3 | In distribution | |
| 493-11-1672-350-3 | 3 | In distribution | |
| 493-11-2631-350-3 | 3 | In distribution | |
| 493-22-2672-385-3 | 3 | In distribution | |
| 493-22-1682-335-3 | 3 | In distribution | |
| 493-92-4610-405-3 | 3 | In distribution | |
| 493-22-2610-355-3 | 3 | In distribution | |
| 493-92-3610-380-3 | 3 | In distribution | |
| 493-22-1610-340-3 | 3 | In distribution | |
| 493-22-1671-335-3 | 3 | In distribution | |
| 493-12-2652-425-3 | 3 | In distribution | |
| 493-92-3631-300-3 | 3 | In distribution | |
| 495-00-3600-405-3 | 3 | In distribution | |
| 493-12-1652-320-3 | 3 | In distribution | |
| 493-21-2671-435-3 | 3 | In distribution | |
| 493-21-1620-395-3 | 3 | In distribution | |
| 491-22-1620-395-3 | 3 | In distribution | |
| 493-11-1671-395-3 | 3 | In distribution | |
| 491-22-2671-410-3 | 3 | In distribution | |
| 493-11-1672-425-3 | 3 | In distribution | |
| 495-00-4600-435-3 | 3 | In distribution | |
| 493-11-1672-330-3 | 3 | In distribution | |
| 493-22-3620-360-3 | 3 | In distribution | |
| 493-92-4691-415-3 | 3 | In distribution | |
| 491-22-1720-385-3 | 3 | In distribution | |
| 493-11-2610-305-3 | 3 | In distribution | |
| 493-11-2652-300-3 | 3 | In distribution | |
| 493-21-2620-410-3 | 3 | In distribution | |
| 493-12-1610-360-3 | 3 | In distribution | |
| 491-12-2672-410-3 | 3 | In distribution | |
| 491-92-4631-405-3 | 3 | In distribution | |
| 493-91-4691-375-3 | 3 | In distribution | |
| 491-91-4610-380-3 | 3 | In distribution | |
| 493-22-2720-365-3 | 3 | In distribution | |
| 493-22-2671-425-3 | 3 | In distribution | |
| 493-21-4720-385-3 | 3 | In distribution | |
| 493-21-4631-385-3 | 3 | In distribution | |
| 493-92-3691-415-3 | 3 | In distribution | |
| 493-92-4691-340-3 | 3 | In distribution | |
| 491-22-3610-300-3 | 3 | In distribution | |
| 495-00-1600-410-3 | 3 | In distribution | |
| 493-21-1620-335-3 | 3 | In distribution | |
| 491-91-4720-335-3 | 3 | In distribution | |
| 491-91-4620-355-3 | 3 | In distribution | |
| 493-92-4720-420-3 | 3 | In distribution | |
| 493-12-2672-425-3 | 3 | In distribution | |
| 493-22-1652-385-3 | 3 | In distribution | |
| 493-22-3610-350-3 | 3 | In distribution | |
| 491-22-2672-355-3 | 3 | In distribution | |
| 491-22-4610-325-3 | 3 | In distribution | |
| 491-92-4610-375-3 | 3 | In distribution | |
| 493-12-2672-330-3 | 3 | In distribution | |
| 493-21-4610-295-3 | 3 | In distribution | |
| 493-92-3610-435-3 | 3 | In distribution | |
| 493-21-1652-320-3 | 3 | In distribution | |
| 491-22-1720-375-3 | 3 | In distribution | |
| 493-12-1672-410-3 | 3 | In distribution | |
| 491-22-2720-430-3 | 3 | In distribution | |
| 493-11-2652-420-3 | 3 | In distribution | |
| 493-22-4620-375-3 | 3 | In distribution | |
| 493-21-2610-400-3 | 3 | In distribution | |
| 491-11-2620-345-3 | 3 | In distribution | |
| 493-11-1620-360-3 | 3 | In distribution | |
| 493-12-2620-330-3 | 3 | In distribution | |
| 493-21-4620-440-3 | 3 | In distribution | |
| 493-22-4720-405-3 | 3 | In distribution | |
| 493-21-1671-440-3 | 3 | In distribution | |
| 493-22-3610-390-3 | 3 | In distribution | |
| 493-22-1671-405-3 | 3 | In distribution | |
| 495-00-4600-340-3 | 3 | In distribution | |
| 493-12-1672-400-3 | 3 | In distribution | |
| 493-92-4720-320-3 | 3 | In distribution | |
| 491-22-2620-350-3 | 3 | In distribution | |
| 493-11-1610-315-3 | 3 | In distribution | |
| 493-12-1610-330-3 | 3 | In distribution | |
| 493-22-4720-395-3 | 3 | In distribution | |
| 493-11-1682-325-3 | 3 | In distribution | |
| 491-92-4631-375-3 | 3 | In distribution | |
| 493-91-3691-345-3 | 3 | In distribution | |
| 491-22-1620-390-3 | 3 | In distribution | |
| 491-91-3610-325-3 | 3 | In distribution | |
| 493-11-2671-395-3 | 3 | In distribution | |
| 493-22-4610-310-3 | 3 | In distribution | |
| 491-21-2610-365-3 | 3 | In distribution | |
| 493-11-1682-435-3 | 3 | In distribution | |
| 493-22-3620-410-3 | 3 | In distribution | |
| 491-92-4620-335-3 | 3 | In distribution | |
| 493-21-4720-405-3 | 3 | In distribution | |
| 493-22-2652-360-3 | 3 | In distribution | |
| 493-22-4620-380-3 | 3 | In distribution | |
| 493-11-2631-295-3 | 3 | In distribution | |
| 493-12-1631-435-3 | 3 | In distribution | |
| 493-12-2610-425-3 | 3 | In distribution | |
| 493-12-2652-420-3 | 3 | In distribution | |
| 493-22-4610-355-3 | 3 | In distribution | |
| 493-91-3631-395-3 | 3 | In distribution | |
| 493-21-1672-415-3 | 3 | In distribution | |
| 491-12-2671-380-3 | 3 | In distribution | |
| 491-21-4610-370-3 | 3 | In distribution | |
| 493-11-2682-385-3 | 3 | In distribution | |
| 493-21-1720-355-3 | 3 | In distribution | |
| 493-21-1620-435-3 | 3 | In distribution | |
| 493-21-3631-430-3 | 3 | In distribution | |
| 493-11-2672-385-3 | 3 | In distribution | |
| 493-21-1610-440-3 | 3 | In distribution | |
| 493-92-4620-365-3 | 3 | In distribution | |
| 493-22-1652-315-3 | 3 | In distribution | |
| 493-12-2652-305-3 | 3 | In distribution | |
| 491-91-4720-380-3 | 3 | In distribution | |
| 493-21-2672-310-3 | 3 | In distribution | |
| 495-00-4600-295-3 | 3 | In distribution | |
| 493-12-2682-315-3 | 3 | In distribution | |
| 493-22-1652-425-3 | 3 | In distribution | |
| 491-11-1620-380-3 | 3 | In distribution | |
| 493-21-3610-325-3 | 3 | In distribution | |
| 493-91-4720-360-3 | 3 | In distribution | |
| 493-22-2720-360-3 | 3 | In distribution | |
| 493-92-4691-410-3 | 3 | In distribution | |
| 493-21-2672-415-3 | 3 | In distribution | |
| 493-22-2652-365-3 | 3 | In distribution | |
| 491-11-1672-390-3 | 3 | In distribution | |
| 491-22-2620-405-3 | 3 | In distribution | |
| 491-22-4720-390-3 | 3 | In distribution | |
| 493-22-1720-300-3 | 3 | In distribution | |
| 493-22-3610-360-3 | 3 | In distribution | |
| 493-11-1682-440-3 | 3 | In distribution | |
| 491-21-4720-305-3 | 3 | In distribution | |
| 493-21-1720-395-3 | 3 | In distribution | |
| 493-21-2682-385-3 | 3 | In distribution | |
| 493-22-4620-365-3 | 3 | In distribution | |
| 493-11-1610-305-3 | 3 | In distribution | |
| 491-11-2672-365-3 | 3 | In distribution | |
| 493-21-1610-300-3 | 3 | In distribution | |
| 493-92-3610-430-3 | 3 | In distribution | |
| 493-92-3620-305-3 | 3 | In distribution | |
| 491-12-2620-405-3 | 3 | In distribution | |
| 493-91-4631-395-3 | 3 | In distribution | |
| 493-11-1652-320-3 | 3 | In distribution | |
| 493-21-1671-425-3 | 3 | In distribution | |
| 493-11-1610-300-3 | 3 | In distribution | |
| 493-11-2620-315-3 | 3 | In distribution | |
| 491-92-3610-395-3 | 3 | In distribution | |
| 491-12-1610-340-3 | 3 | In distribution | |
| 491-92-4610-395-3 | 3 | In distribution | |
| 493-22-1652-310-3 | 3 | In distribution | |
| 491-92-3610-375-3 | 3 | In distribution | |
| 493-22-4620-345-3 | 3 | In distribution | |
| 493-91-3610-370-3 | 3 | In distribution | |
| 493-12-1610-315-3 | 3 | In distribution | |
| 493-12-1720-405-3 | 3 | In distribution | |
| 493-21-2720-425-3 | 3 | In distribution | |
| 495-00-2600-440-3 | 3 | In distribution | |
| 493-92-4610-335-3 | 3 | In distribution | |
| 491-22-3720-410-3 | 3 | In distribution | |
| 493-12-1620-400-3 | 3 | In distribution | |
| 493-11-2620-330-3 | 3 | In distribution | |
| 493-12-1631-320-3 | 3 | In distribution | |
| 493-91-4610-360-3 | 3 | In distribution | |
| 491-22-2620-410-3 | 3 | In distribution | |
| 493-22-3620-400-3 | 3 | In distribution | |
| 493-11-1682-350-3 | 3 | In distribution | |
| 493-22-3720-405-3 | 3 | In distribution | |
| 493-92-3610-315-3 | 3 | In distribution | |
| 493-12-2671-395-3 | 3 | In distribution | |
| 493-22-2672-365-3 | 3 | In distribution | |
| 493-91-4620-380-3 | 3 | In distribution | |
| 491-22-2620-435-3 | 3 | In distribution | |
| 493-11-2671-385-3 | 3 | In distribution | |
| 493-22-4720-295-3 | 3 | In distribution | |
| 493-22-2682-320-3 | 3 | In distribution | |
| 493-91-3610-340-3 | 3 | In distribution | |
| 491-12-2610-385-3 | 3 | In distribution | |
| 493-11-2631-410-3 | 3 | In distribution | |
| 493-21-2620-370-3 | 3 | In distribution | |
| 493-91-4720-375-3 | 3 | In distribution | |
| 491-92-4620-370-3 | 3 | In distribution | |
| 493-12-2610-335-3 | 3 | In distribution | |
| 493-22-4631-410-3 | 3 | In distribution | |
| 493-91-3631-305-3 | 3 | In distribution | |
| 493-21-2671-360-3 | 3 | In distribution | |
| 493-92-4720-295-3 | 3 | In distribution | |
| 493-22-3720-435-3 | 3 | In distribution | |
| 491-21-4720-400-3 | 3 | In distribution | |
| 493-11-1610-360-3 | 3 | In distribution | |
| 493-12-2682-320-3 | 3 | In distribution | |
| 495-00-2600-315-3 | 3 | In distribution | |
| 493-22-4720-330-3 | 3 | In distribution | |
| 491-22-1620-300-3 | 3 | In distribution | |
| 493-11-2631-365-3 | 3 | In distribution | |
| 493-11-1720-315-3 | 3 | In distribution | |
| 493-12-1610-405-3 | 3 | In distribution | |
| 493-21-1671-415-3 | 3 | In distribution | |
| 493-22-2620-375-3 | 3 | In distribution | |
| 493-22-3610-365-3 | 3 | In distribution | |
| 493-92-3720-425-3 | 3 | In distribution | |
| 493-12-2610-435-3 | 3 | In distribution | |
| 493-11-1720-365-3 | 3 | In distribution | |
| 493-21-2620-320-3 | 3 | In distribution | |
| 493-22-3620-380-3 | 3 | In distribution | |
| 493-11-2671-410-3 | 3 | In distribution | |
| 493-21-2610-375-3 | 3 | In distribution | |
| 491-92-4720-330-3 | 3 | In distribution | |
| 493-22-2682-380-3 | 3 | In distribution | |
| 491-12-1671-430-3 | 3 | In distribution | |
| 493-12-1620-305-3 | 3 | In distribution | |
| 493-21-2671-325-3 | 3 | In distribution | |
| 493-11-1631-410-3 | 3 | In distribution | |
| 493-21-1671-365-3 | 3 | In distribution | |
| 493-91-4720-310-3 | 3 | In distribution | |
| 493-92-4691-325-3 | 3 | In distribution | |
| 493-11-1652-360-3 | 3 | In distribution | |
| 493-92-4610-390-3 | 3 | In distribution | |
| 491-91-3631-440-3 | 3 | In distribution | |
| 493-21-3620-310-3 | 3 | In distribution | |
| 491-21-1672-370-3 | 3 | In distribution | |
| 493-22-4631-425-3 | 3 | In distribution | |
| 491-91-3631-390-3 | 3 | In distribution | |
| 493-22-4631-420-3 | 3 | In distribution | |
| 493-91-3631-315-3 | 3 | In distribution | |
| 491-91-4720-360-3 | 3 | In distribution | |
| 493-21-2671-425-3 | 3 | In distribution | |
| 491-11-2610-355-3 | 3 | In distribution | |
| 493-12-2682-425-3 | 3 | In distribution | |
| 491-92-4620-375-3 | 3 | In distribution | |
| 493-11-1610-370-3 | 3 | In distribution | |
| 493-12-2610-340-3 | 3 | In distribution | |
| 493-21-4610-415-3 | 3 | In distribution | |
| 493-91-3631-360-3 | 3 | In distribution | |
| 493-91-4620-305-3 | 3 | In distribution | |
| 493-22-1652-335-3 | 3 | In distribution | |
| 493-92-4691-395-3 | 3 | In distribution | |
| 491-22-1671-345-3 | 3 | In distribution | |
| 493-11-2652-410-3 | 3 | In distribution | |
| 493-21-1720-375-3 | 3 | In distribution | |
| 493-21-2652-425-3 | 3 | In distribution | |
| 493-21-3620-415-3 | 3 | In distribution | |
| 493-11-2720-370-3 | 3 | In distribution | |
| 493-22-1610-315-3 | 3 | In distribution | |
| 493-22-3720-365-3 | 3 | In distribution | |
| 491-22-2620-440-3 | 3 | In distribution | |
| 491-91-4610-350-3 | 3 | In distribution | |
| 493-11-2671-390-3 | 3 | In distribution | |
| 493-21-1671-380-3 | 3 | In distribution | |
| 493-92-3620-365-3 | 3 | In distribution | |
| 493-11-1720-380-3 | 3 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Band, Preformed, Orthodontic | Forestadent Bernhard Förster GmbH | 8,646 |
| TruFit 2.0 | Ortho Technology, Inc. | 4,890 |
| 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 |
| Rollo Bands | American Orthodontics | 660 |
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.