Dentaform®
Mini-Assortment dentaform® Bands, Tooth 46, unwelded easy adaptation/ For further information please visit our online-shop on our website www.dentaurum.de
27manufacturers in China registered for this device type
1,763catalogue 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 | Dentaurum GmbH & Co. KG, Germany |
|---|---|
| FDA product code | ECM |
| Device type | Band, Preformed, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-15 |
| Record revised | 2019-09-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: No special storage conditions required |
| Distribution end date | 2019-10-22 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 882-028-00 | 10 | In distribution | |
| 880-307-22 | In distribution | ||
| 878-302-22 | In distribution | ||
| 881-327-18 | In distribution | ||
| 878-013-18 | In distribution | ||
| 882-317-18 | In distribution | ||
| 879-033-00 | 10 | In distribution | |
| 882-025-00 | 10 | In distribution | |
| 879-314-18 | In distribution | ||
| 878-028-22 | In distribution | ||
| 880-215-00 | 10 | In distribution | |
| 878-312-22 | In distribution | ||
| 883-319-22 | In distribution | ||
| 878-018-22 | In distribution | ||
| 883-364-22 | In distribution | ||
| 883-020-00 | 10 | In distribution | |
| 882-013-00 | 10 | In distribution | |
| 880-325-22 | In distribution | ||
| 880-205-00 | 10 | In distribution | |
| 883-327-18 | In distribution | ||
| 880-323-18 | In distribution | ||
| 882-301-22 | In distribution | ||
| 878-021-22 | In distribution | ||
| 879-304-22 | In distribution | ||
| 886-024-00 | 10 | In distribution | |
| 878-020-22 | In distribution | ||
| 883-320-18 | In distribution | ||
| 883-305-22 | In distribution | ||
| 881-317-18 | In distribution | ||
| 885-331-18 | In distribution | ||
| 884-300-00 | In distribution | ||
| 880-315-22 | In distribution | ||
| 884-320-18 | In distribution | ||
| 888-008-00 | 10 | In distribution | |
| 885-312-22 | In distribution | ||
| 878-317-18 | In distribution | ||
| 883-310-22 | In distribution | ||
| 885-364-18 | 64 | In distribution | |
| 878-022-22 | In distribution | ||
| 878-315-22 | In distribution | ||
| 885-317-22 | In distribution | ||
| 882-022-00 | 10 | In distribution | |
| 888-001-00 | 10 | In distribution | |
| 884-332-18 | In distribution | ||
| 881-312-22 | In distribution | ||
| 883-301-18 | In distribution | ||
| 882-318-18 | In distribution | ||
| 878-325-18 | In distribution | ||
| 878-010-18 | In distribution | ||
| 878-311-22 | In distribution | ||
| 880-317-22 | In distribution | ||
| 879-008-00 | 10 | In distribution | |
| 879-301-22 | In distribution | ||
| 885-328-18 | In distribution | ||
| 883-310-18 | In distribution | ||
| 880-364-18 | 64 | In distribution | |
| 886-008-00 | 10 | In distribution | |
| 881-335-22 | In distribution | ||
| 887-026-00 | 10 | In distribution | |
| 885-309-18 | In distribution | ||
| 882-336-22 | In distribution | ||
| 883-335-22 | In distribution | ||
| 880-220-00 | 10 | In distribution | |
| 884-026-00 | 10 | In distribution | |
| 879-312-22 | In distribution | ||
| 885-350-18 | 150 | In distribution | |
| 880-301-18 | In distribution | ||
| 885-302-18 | In distribution | ||
| 883-014-00 | 10 | In distribution | |
| 880-225-00 | 10 | In distribution | |
| 885-326-18 | In distribution | ||
| 885-336-22 | In distribution | ||
| 883-300-00 | In distribution | ||
| 883-031-00 | 10 | In distribution | |
| 883-364-18 | 64 | In distribution | |
| 884-336-18 | In distribution | ||
| 889-022-00 | 10 | In distribution | |
| 886-032-00 | 10 | In distribution | |
| 887-004-00 | 10 | In distribution | |
| 885-025-00 | 10 | In distribution | |
| 882-321-18 | In distribution | ||
| 879-009-00 | 10 | In distribution | |
| 879-018-00 | 10 | In distribution | |
| 880-204-00 | 10 | In distribution | |
| 885-305-18 | In distribution | ||
| 880-322-18 | In distribution | ||
| 879-332-22 | In distribution | ||
| 884-305-18 | In distribution | ||
| 878-335-22 | In distribution | ||
| 882-327-18 | In distribution | ||
| 888-015-00 | 10 | In distribution | |
| 878-364-22 | 64 | In distribution | |
| 878-329-22 | In distribution | ||
| 879-331-22 | In distribution | ||
| 879-032-00 | 10 | In distribution | |
| 884-328-22 | In distribution | ||
| 885-324-18 | In distribution | ||
| 880-334-22 | In distribution | ||
| 881-306-22 | In distribution | ||
| 881-325-18 | In distribution | ||
| 880-318-18 | In distribution | ||
| 887-020-00 | 10 | In distribution | |
| 885-015-00 | 10 | In distribution | |
| 879-308-18 | In distribution | ||
| 884-008-00 | 10 | In distribution | |
| 878-004-22 | In distribution | ||
| 884-322-22 | In distribution | ||
| 881-206-00 | 10 | In distribution | |
| 881-315-18 | In distribution | ||
| 880-218-00 | 10 | In distribution | |
| 879-313-22 | In distribution | ||
| 886-031-00 | 10 | In distribution | |
| 878-014-00 | 10 | In distribution | |
| 884-030-00 | 10 | In distribution | |
| 878-323-18 | In distribution | ||
| 887-014-00 | 10 | In distribution | |
| 878-313-22 | In distribution | ||
| 882-328-18 | In distribution | ||
| 880-325-18 | In distribution | ||
| 879-014-00 | 10 | In distribution | |
| 882-350-18 | 150 | In distribution | |
| 889-024-00 | 10 | In distribution | |
| 878-309-18 | In distribution | ||
| 882-330-22 | In distribution | ||
| 883-035-00 | 10 | In distribution | |
| 878-322-22 | In distribution | ||
| 887-029-00 | 10 | In distribution | |
| 882-317-22 | In distribution | ||
| 881-327-22 | In distribution | ||
| 881-324-18 | In distribution | ||
| 880-301-22 | In distribution | ||
| 879-013-00 | 10 | In distribution | |
| 878-015-00 | 10 | In distribution | |
| 886-021-00 | 10 | In distribution | |
| 884-327-22 | In distribution | ||
| 878-019-00 | 10 | In distribution | |
| 883-307-22 | In distribution | ||
| 884-317-22 | In distribution | ||
| 883-331-18 | In distribution | ||
| 883-001-00 | 10 | In distribution | |
| 878-001-00 | 10 | In distribution | |
| 878-334-18 | In distribution | ||
| 879-306-18 | In distribution | ||
| 883-034-00 | 10 | In distribution | |
| 881-329-18 | In distribution | ||
| 882-335-18 | In distribution | ||
| 878-309-22 | In distribution | ||
| 885-036-00 | 10 | In distribution | |
| 879-027-00 | 10 | In distribution | |
| 883-317-18 | In distribution | ||
| 880-350-22 | In distribution | ||
| 881-331-22 | In distribution | ||
| 889-013-00 | 10 | In distribution | |
| 885-313-22 | In distribution | ||
| 888-022-00 | 10 | In distribution | |
| 884-005-00 | 10 | In distribution | |
| 885-306-18 | In distribution | ||
| 881-320-22 | In distribution | ||
| 885-318-18 | In distribution | ||
| 878-315-18 | In distribution | ||
| 883-015-00 | 10 | In distribution | |
| 882-008-00 | 10 | In distribution | |
| 883-332-22 | In distribution | ||
| 884-304-22 | In distribution | ||
| 878-003-00 | 10 | In distribution | |
| 885-024-00 | 10 | In distribution | |
| 878-030-18 | In distribution | ||
| 883-321-18 | In distribution | ||
| 881-210-00 | 10 | In distribution | |
| 881-217-00 | 10 | In distribution | |
| 882-312-18 | In distribution | ||
| 888-020-00 | 10 | In distribution | |
| 880-332-22 | In distribution | ||
| 879-309-18 | In distribution | ||
| 884-009-00 | 10 | In distribution | |
| 884-302-22 | In distribution | ||
| 880-208-00 | 10 | In distribution | |
| 878-035-00 | 10 | In distribution | |
| 880-302-18 | In distribution | ||
| 879-328-18 | In distribution | ||
| 883-314-22 | In distribution | ||
| 881-215-00 | 10 | In distribution | |
| 885-323-22 | In distribution | ||
| 880-323-22 | In distribution | ||
| 884-021-00 | 10 | In distribution | |
| 888-026-00 | 10 | In distribution | |
| 879-302-22 | In distribution | ||
| 885-319-22 | In distribution | ||
| 879-303-18 | In distribution | ||
| 878-321-18 | In distribution | ||
| 882-313-22 | In distribution | ||
| 882-302-18 | In distribution | ||
| 881-315-22 | In distribution | ||
| 880-328-18 | In distribution | ||
| 880-201-00 | 10 | In distribution | |
| 883-018-00 | 10 | In distribution | |
| 881-336-22 | In distribution | ||
| 882-306-18 | In distribution | ||
| 887-016-00 | 10 | In distribution | |
| 881-214-00 | 10 | In distribution | |
| 881-310-22 | In distribution | ||
| 883-329-18 | In distribution | ||
| 885-304-22 | In distribution | ||
| 881-211-00 | 10 | In distribution | |
| 889-017-00 | 10 | In distribution | |
| 885-326-22 | In distribution | ||
| 882-031-00 | 10 | In distribution | |
| 880-321-22 | In distribution | ||
| 878-314-22 | In distribution | ||
| 880-335-22 | In distribution | ||
| 888-025-00 | 10 | In distribution | |
| 883-318-22 | In distribution | ||
| 888-150-00 | In distribution | ||
| 887-027-00 | 10 | In distribution | |
| 885-306-22 | In distribution | ||
| 879-003-00 | 10 | In distribution | |
| 879-336-18 | In distribution | ||
| 884-036-00 | 10 | In distribution | |
| 885-323-18 | In distribution | ||
| 889-001-00 | 10 | In distribution | |
| 878-326-18 | In distribution | ||
| 883-026-00 | 10 | In distribution | |
| 880-309-22 | In distribution | ||
| 878-010-00 | 10 | In distribution | |
| 879-322-18 | In distribution | ||
| 885-027-00 | 10 | In distribution | |
| 880-320-18 | In distribution | ||
| 882-033-00 | 10 | In distribution | |
| 883-002-00 | 10 | In distribution | |
| 879-313-18 | In distribution | ||
| 888-030-00 | 10 | In distribution | |
| 882-304-22 | In distribution | ||
| 885-364-22 | In distribution | ||
| 878-025-18 | In distribution | ||
| 878-028-18 | In distribution | ||
| 882-032-00 | 10 | In distribution | |
| 884-318-18 | In distribution | ||
| 883-308-18 | In distribution | ||
| 881-235-00 | 10 | In distribution | |
| 879-350-18 | 150 | In distribution | |
| 887-015-00 | 10 | In distribution | |
| 884-307-18 | In distribution | ||
| 882-006-00 | 10 | In distribution | |
| 884-312-22 | In distribution | ||
| 885-335-18 | In distribution | ||
| 884-321-22 | In distribution | ||
| 879-309-22 | In distribution | ||
| 878-334-22 | In distribution | ||
| 878-025-22 | In distribution | ||
| 883-322-18 | 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 |
| TruFit™ | Ortho Organizers, Inc. | 3,943 |
| Leone SPA | Leone SPA | 2,549 |
| 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.