Retainer, Screw Expansion, Orthodontic
Variety click Mini - 8, straight / Monoguided special expansion screw with click feature to prevent unwanted reversing / For further information please visit our online-sho
30manufacturers in China registered for this device type
243catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (13), Guangdong (9), Jiangsu (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Veden Dental Labs Inc | Zhuhai | Guangdong | Contract manufacturer | 9 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| 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 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Guangzhou Cheer-U Material Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 15 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| United Dental Changzhou | Changzhou | Jiangsu | Manufacturer | 12 |
Showing 12 of 30. All 30 manufacturers in China registered for Retainer, Screw Expansion, Orthodontic
Record
| Listed by | Dentaurum GmbH & Co. KG, Germany |
|---|---|
| FDA product code | DYJ |
| Device type | Retainer, Screw Expansion, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-15 |
| Record revised | 2023-11-17 (version 7) |
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 | 2024-09-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 607-126-22 | In distribution | ||
| 602-837-50 | 50 | In distribution | |
| 602-806-13 | In distribution | ||
| 602-836-55 | 50 | In distribution | |
| 607-104-11 | 10 | In distribution | |
| 602-846-11 | In distribution | ||
| 603-000-00 | In distribution | ||
| 609-008-00 | 10 | In distribution | |
| 607-154-00 | 10 | In distribution | |
| 607-107-11 | 10 | In distribution | |
| 607-126-34 | 10 | In distribution | |
| 607-112-00 | 10 | In distribution | |
| 602-809-31 | 10 | In distribution | |
| 602-837-11 | In distribution | ||
| 600-322-60 | 100 | In distribution | |
| 602-847-11 | In distribution | ||
| 602-846-55 | 50 | In distribution | |
| 607-115-00 | 2 | In distribution | |
| 607-108-10 | 10 | In distribution | |
| 611-115-60 | 100 | In distribution | |
| 602-806-33 | 10 | In distribution | |
| 600-322-10 | In distribution | ||
| 602-837-55 | 50 | In distribution | |
| 602-809-33 | 10 | In distribution | |
| 602-838-11 | In distribution | ||
| 602-819-11 | In distribution | ||
| 602-837-10 | In distribution | ||
| 602-815-12 | In distribution | ||
| 607-108-20 | 10 | In distribution | |
| 602-806-32 | 10 | In distribution | |
| 600-503-60 | 100 | In distribution | |
| 600-303-60 | 100 | In distribution | |
| 602-838-50 | 50 | In distribution | |
| 602-838-55 | 50 | In distribution | |
| 602-839-30 | 10 | In distribution | |
| 607-126-44 | 10 | In distribution | |
| 607-127-30 | 10 | In distribution | |
| 602-806-10 | In distribution | ||
| 606-600-30 | 10 | In distribution | |
| 607-102-00 | 10 | In distribution | |
| 607-124-00 | In distribution | ||
| 600-000-00 | In distribution | ||
| 607-122-30 | 10 | In distribution | |
| 606-701-30 | 10 | In distribution | |
| 602-839-11 | In distribution | ||
| 600-610-30 | 10 | In distribution | |
| 602-819-31 | 10 | In distribution | |
| 611-131-00 | 50 | In distribution | |
| 609-004-00 | 10 | In distribution | |
| 600-301-60 | 100 | In distribution | |
| 602-839-13 | In distribution | ||
| 607-108-00 | In distribution | ||
| 600-310-30 | 10 | In distribution | |
| 602-838-33 | 10 | In distribution | |
| 600-321-30 | 10 | In distribution | |
| 602-836-33 | 10 | In distribution | |
| 602-847-33 | 10 | In distribution | |
| 602-809-30 | 10 | In distribution | |
| 600-320-30 | 10 | In distribution | |
| 602-806-11 | In distribution | ||
| 607-116-00 | 10 | In distribution | |
| 607-158-00 | 2 | In distribution | |
| 611-132-00 | 50 | In distribution | |
| 611-116-00 | In distribution | ||
| 609-500-00 | In distribution | ||
| 602-840-31 | 10 | In distribution | |
| 602-806-12 | In distribution | ||
| 602-847-13 | In distribution | ||
| 602-806-31 | 10 | In distribution | |
| 602-838-31 | 10 | In distribution | |
| 602-839-10 | In distribution | ||
| 602-845-33 | 10 | In distribution | |
| 600-500-60 | 100 | In distribution | |
| 611-115-00 | In distribution | ||
| 602-809-32 | 10 | In distribution | |
| 600-300-60 | 100 | In distribution | |
| 607-126-40 | 10 | In distribution | |
| 602-806-50 | 50 | In distribution | |
| 607-156-00 | 6 | In distribution | |
| 600-300-30 | 10 | In distribution | |
| 600-501-10 | In distribution | ||
| 602-845-55 | 50 | In distribution | |
| 607-126-24 | In distribution | ||
| 600-501-30 | 10 | In distribution | |
| 600-322-30 | 10 | In distribution | |
| 602-837-30 | 10 | In distribution | |
| 611-115-30 | 10 | In distribution | |
| 602-846-31 | 10 | In distribution | |
| 607-153-00 | 2 | In distribution | |
| 600-320-60 | 100 | In distribution | |
| 602-846-13 | In distribution | ||
| 607-121-00 | In distribution | ||
| 607-157-00 | In distribution | ||
| 602-806-55 | 50 | In distribution | |
| 606-701-00 | In distribution | ||
| 600-303-10 | In distribution | ||
| 602-606-10 | In distribution | ||
| 602-845-11 | In distribution | ||
| 607-105-00 | 10 | In distribution | |
| 609-200-30 | 10 | In distribution | |
| 602-838-13 | In distribution | ||
| 602-819-33 | 10 | In distribution | |
| 606-600-00 | In distribution | ||
| 607-121-30 | 10 | In distribution | |
| 602-819-30 | 10 | In distribution | |
| 602-837-12 | In distribution | ||
| 600-301-30 | 10 | In distribution | |
| 602-815-33 | 10 | In distribution | |
| 607-105-11 | 10 | In distribution | |
| 602-836-11 | In distribution | ||
| 602-809-13 | In distribution | ||
| 602-819-55 | 50 | In distribution | |
| 602-836-10 | In distribution | ||
| 602-839-33 | 10 | In distribution | |
| 607-147-00 | In distribution | ||
| 602-819-13 | In distribution | ||
| 600-001-30 | 10 | In distribution | |
| 607-159-00 | 2 | In distribution | |
| 602-837-31 | 10 | In distribution | |
| 607-120-00 | In distribution | ||
| 600-610-00 | In distribution | ||
| 600-502-10 | In distribution | ||
| 607-126-42 | 10 | In distribution | |
| 600-502-60 | 100 | In distribution | |
| 602-836-32 | 10 | In distribution | |
| 600-321-10 | In distribution | ||
| 602-815-13 | In distribution | ||
| 602-839-50 | 50 | In distribution | |
| 602-836-50 | 50 | In distribution | |
| 602-819-32 | 10 | In distribution | |
| 602-847-31 | 10 | In distribution | |
| 600-500-10 | In distribution | ||
| 607-103-11 | 10 | In distribution | |
| 602-806-01 | In distribution | ||
| 602-809-12 | In distribution | ||
| 607-103-00 | 10 | In distribution | |
| 602-815-50 | 50 | In distribution | |
| 600-500-30 | 10 | In distribution | |
| 607-160-00 | In distribution | ||
| 602-815-10 | In distribution | ||
| 600-600-30 | 10 | In distribution | |
| 607-101-00 | 10 | In distribution | |
| 600-503-30 | 10 | In distribution | |
| 607-118-00 | 10 | In distribution | |
| 602-845-13 | In distribution | ||
| 602-838-12 | In distribution | ||
| 602-604-10 | In distribution | ||
| 602-839-12 | In distribution | ||
| 602-836-30 | 10 | In distribution | |
| 600-301-10 | In distribution | ||
| 602-839-32 | 10 | In distribution | |
| 611-130-00 | 50 | In distribution | |
| 600-002-00 | In distribution | ||
| 607-125-00 | In distribution | ||
| 612-000-00 | In distribution | ||
| 602-815-31 | 10 | In distribution | |
| 602-819-10 | In distribution | ||
| 602-815-32 | 10 | In distribution | |
| 607-109-00 | 10 | In distribution | |
| 602-847-55 | 50 | In distribution | |
| 602-815-30 | 10 | In distribution | |
| 607-151-00 | 6 | In distribution | |
| 607-122-00 | In distribution | ||
| 602-809-50 | 50 | In distribution | |
| 602-845-31 | 10 | In distribution | |
| 602-605-10 | In distribution | ||
| 602-837-13 | In distribution | ||
| 607-107-00 | 10 | In distribution | |
| 600-001-00 | In distribution | ||
| 600-320-10 | In distribution | ||
| 602-815-11 | In distribution | ||
| 600-302-10 | In distribution | ||
| 602-815-55 | 50 | In distribution | |
| 602-846-33 | 10 | In distribution | |
| 607-165-00 | In distribution | ||
| 607-152-00 | 6 | In distribution | |
| 600-501-60 | 100 | In distribution | |
| 607-117-00 | 10 | In distribution | |
| 602-840-11 | In distribution | ||
| 607-126-32 | 10 | In distribution | |
| 602-819-12 | In distribution | ||
| 600-303-30 | 10 | In distribution | |
| 602-809-55 | 50 | In distribution | |
| 602-836-12 | In distribution | ||
| 600-302-60 | 100 | In distribution | |
| 607-145-01 | In distribution | ||
| 602-838-10 | In distribution | ||
| 602-836-31 | 10 | In distribution | |
| 607-104-00 | 10 | In distribution | |
| 600-601-30 | 10 | In distribution | |
| 602-839-55 | 50 | In distribution | |
| 600-300-10 | In distribution | ||
| 600-302-30 | 10 | In distribution | |
| 602-809-10 | In distribution | ||
| 607-111-00 | 10 | In distribution | |
| 600-602-30 | 10 | In distribution | |
| 607-126-20 | In distribution | ||
| 602-837-33 | 10 | In distribution | |
| 602-839-31 | 10 | In distribution | |
| 609-006-00 | 10 | In distribution | |
| 602-806-30 | 10 | In distribution | |
| 602-838-32 | 10 | In distribution | |
| 607-110-00 | 10 | In distribution | |
| 600-502-30 | 10 | In distribution | |
| 602-836-13 | In distribution | ||
| 602-809-11 | In distribution | ||
| 600-002-30 | 10 | In distribution | |
| 600-321-60 | 100 | In distribution | |
| 600-503-10 | In distribution | ||
| 602-840-55 | 50 | In distribution | |
| 607-128-00 | In distribution | ||
| 607-126-30 | 10 | In distribution | |
| 602-838-30 | 10 | In distribution | |
| 602-819-50 | 50 | In distribution | |
| 602-837-32 | 10 | In distribution | |
| 607-126-38 | 10 | Withdrawn | |
| 607-150-00 | 6 | Withdrawn | |
| 607-141-00 | 6 | Withdrawn | |
| 602-836-01 | Withdrawn | ||
| 607-126-18 | Withdrawn | ||
| 602-806-00 | Withdrawn | ||
| 602-819-00 | Withdrawn | ||
| 602-839-01 | Withdrawn | ||
| 602-838-00 | Withdrawn | ||
| 602-837-01 | Withdrawn | ||
| 602-809-01 | Withdrawn | ||
| 602-838-01 | Withdrawn | ||
| 602-815-00 | Withdrawn | ||
| 602-836-00 | Withdrawn | ||
| 602-839-00 | Withdrawn | ||
| 607-148-00 | Withdrawn | ||
| 602-819-01 | Withdrawn | ||
| 607-140-01 | Withdrawn | ||
| 607-142-00 | 6 | Withdrawn | |
| 607-143-00 | 2 | Withdrawn | |
| 602-837-00 | Withdrawn | ||
| 602-815-01 | Withdrawn | ||
| 602-809-00 | Withdrawn | ||
| 607-136-00 | 10 | Withdrawn | |
| 607-146-00 | 6 | Withdrawn | |
| 607-149-00 | 2 | Withdrawn | |
| 607-126-28 | 10 | Withdrawn | |
| 611-120-00 | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Leone SPA | Leone SPA | 441 |
| Retainer, Screw Expansion, Orthodontic | Forestadent Bernhard Förster GmbH | 203 |
| Orthosource | Orthosource, Inc. | 110 |
| Hanks Telescoping Herbst | American Orthodontics | 95 |
| palex® | Dentaurum GmbH & Co. KG | 60 |
| Bondable Lingual Retainer | TP Orthodontics, Inc. | 60 |
| Distal Jet | American Orthodontics | 42 |
| Cantilever Bar Offset | American Orthodontics | 38 |
| Miniscope Telescoping Herbst | American Orthodontics | 37 |
| RMO | RMO | 33 |
| Palatal Arches | American Orthodontics | 28 |
| Morelli | Dental Morelli Ltda. | 28 |
Showing 12 of 295. All products under Retainer, Screw Expansion, 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.