Remanium®
remanium® straight wires, rectangular, spring hard plus, 0.55 x 0.70 mm / 21.5 x 28
43manufacturers in China registered for this device type
121catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (15), Guangdong (9), Jiangsu (6). 7 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 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Zhejiang Eksen Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 9 |
| Yancheng Denrum Medical Apparatus Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 5 |
| Heilongjiang Rainbow Technology Co., Ltd. | Jiamusi | Heilongjiang | Contract manufacturer | 2 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| 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 |
Showing 12 of 43. All 43 manufacturers in China registered for Wire, Orthodontic
Record
| Listed by | Dentaurum GmbH & Co. KG, Germany |
|---|---|
| FDA product code | DZC |
| Device type | Wire, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K935140 |
| Record published | 2016-09-15 |
| Record revised | 2024-06-19 (version 4) |
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 | 2024-06-19 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 765-302-00 | 10 | In distribution | |
| 523-080-00 | In distribution | ||
| 751-000-00 | 1,000 | In distribution | |
| 535-009-00 | 25 | In distribution | |
| 767-100-01 | 50 | In distribution | |
| 537-413-00 | 10 | In distribution | |
| 767-201-00 | 10 | In distribution | |
| 535-005-00 | 25 | In distribution | |
| 767-206-00 | 10 | In distribution | |
| 501-025-00 | In distribution | ||
| 751-004-00 | 100 | In distribution | |
| 535-045-00 | 25 | In distribution | |
| 513-100-00 | In distribution | ||
| 308-513-00 | In distribution | ||
| 767-202-00 | 10 | In distribution | |
| 767-104-00 | 10 | In distribution | |
| 767-105-01 | 50 | In distribution | |
| 767-203-01 | 50 | In distribution | |
| 523-150-00 | In distribution | ||
| 767-107-00 | 10 | In distribution | |
| 530-045-00 | In distribution | ||
| 530-035-00 | In distribution | ||
| 523-110-00 | In distribution | ||
| 767-200-01 | 50 | In distribution | |
| 523-050-00 | In distribution | ||
| 765-301-00 | 10 | In distribution | |
| 537-424-00 | 10 | In distribution | |
| 514-090-00 | In distribution | ||
| 537-340-00 | 10 | In distribution | |
| 527-070-00 | 25 | In distribution | |
| 524-090-00 | In distribution | ||
| 527-006-00 | 500 | In distribution | |
| 765-303-00 | 10 | In distribution | |
| 765-201-01 | 50 | In distribution | |
| 766-768-00 | 10 | In distribution | |
| 767-205-01 | 50 | In distribution | |
| 523-060-00 | In distribution | ||
| 308-518-00 | In distribution | ||
| 766-769-00 | 10 | In distribution | |
| 524-060-00 | In distribution | ||
| 537-310-00 | 10 | In distribution | |
| 527-005-00 | 500 | In distribution | |
| 308-515-00 | In distribution | ||
| 535-040-00 | 25 | In distribution | |
| 767-201-01 | 50 | In distribution | |
| 524-080-00 | In distribution | ||
| 515-020-00 | In distribution | ||
| 503-050-00 | In distribution | ||
| 537-440-00 | 10 | In distribution | |
| 765-202-01 | 50 | In distribution | |
| 513-150-00 | In distribution | ||
| 308-520-00 | In distribution | ||
| 767-106-00 | 10 | In distribution | |
| 523-100-00 | In distribution | ||
| 500-025-00 | In distribution | ||
| 385-630-00 | In distribution | ||
| 385-624-00 | In distribution | ||
| 537-410-00 | 10 | In distribution | |
| 527-080-00 | 25 | In distribution | |
| 514-100-00 | In distribution | ||
| 527-004-00 | 500 | In distribution | |
| 535-003-00 | 25 | In distribution | |
| 535-002-00 | 25 | In distribution | |
| 765-201-00 | 10 | In distribution | |
| 766-767-00 | 10 | In distribution | |
| 308-715-00 | In distribution | ||
| 537-311-00 | 10 | In distribution | |
| 767-207-00 | 10 | In distribution | |
| 767-200-00 | 10 | In distribution | |
| 535-035-00 | 25 | In distribution | |
| 767-203-00 | 10 | In distribution | |
| 523-070-00 | In distribution | ||
| 767-204-00 | 10 | In distribution | |
| 751-001-00 | 1,000 | In distribution | |
| 535-048-00 | 25 | In distribution | |
| 513-090-00 | In distribution | ||
| 765-200-00 | 10 | In distribution | |
| 501-050-00 | In distribution | ||
| 521-040-00 | In distribution | ||
| 527-090-00 | 25 | In distribution | |
| 765-202-00 | 10 | In distribution | |
| 537-411-00 | 10 | In distribution | |
| 523-090-00 | In distribution | ||
| 524-070-00 | In distribution | ||
| 513-070-00 | In distribution | ||
| 766-770-00 | 10 | In distribution | |
| 524-110-00 | In distribution | ||
| 524-100-00 | In distribution | ||
| 514-080-00 | In distribution | ||
| 537-324-00 | 10 | In distribution | |
| 525-040-00 | 25 | In distribution | |
| 514-070-00 | In distribution | ||
| 767-103-01 | 50 | In distribution | |
| 527-100-00 | 25 | In distribution | |
| 500-030-00 | In distribution | ||
| 767-100-00 | 10 | In distribution | |
| 767-101-00 | 10 | In distribution | |
| 513-080-00 | In distribution | ||
| 767-102-00 | 10 | In distribution | |
| 513-120-00 | In distribution | ||
| 751-005-00 | 100 | In distribution | |
| 751-003-00 | 100 | In distribution | |
| 767-205-00 | 10 | In distribution | |
| 537-314-00 | 10 | In distribution | |
| 537-414-00 | 10 | In distribution | |
| 765-203-00 | 10 | In distribution | |
| 765-301-01 | 50 | In distribution | |
| 308-718-00 | In distribution | ||
| 500-040-00 | In distribution | ||
| 765-302-01 | 50 | In distribution | |
| 530-040-00 | In distribution | ||
| 535-051-00 | 25 | In distribution | |
| 767-101-01 | 50 | In distribution | |
| 308-713-00 | In distribution | ||
| 767-103-00 | 10 | In distribution | |
| 765-300-00 | 10 | In distribution | |
| 537-423-00 | 10 | In distribution | |
| 523-120-00 | In distribution | ||
| 767-105-00 | 10 | In distribution | |
| 537-313-00 | 10 | In distribution | |
| 765-113-00 | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wire, Orthodontic | G & H Wire Company | 2,746 |
| Europa | G & H Wire Company | 2,409 |
| Pg Supply | PG Supply, Inc. | 1,990 |
| Trueform | G & H Wire Company | 1,984 |
| G4 Nickel Titanium | G & H Wire Company | 957 |
| Tanzo | American Orthodontics | 906 |
| Aditek | Aditek DO Brasil S/A | 879 |
| G4 Europa Nickel Titanium | G & H Wire Company | 819 |
| 3M™ Unitek™ | 3M Unitek | 729 |
| Orthodontic wire | Dentos, Incorporated | 711 |
| Orthoquest | Young Innovations Inc. | 698 |
| NT3 | American Orthodontics | 694 |
Showing 12 of 679. All products under Wire, 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.