Miniscope Telescoping Herbst
Miniscope Telescoping Mechanism 27MM Right W/ROD CUP 10/PK
30manufacturers in China registered for this device type
37catalogue numbers in this listing
1510(k) clearance
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 | American Orthodontics, United States |
|---|---|
| FDA product code | DYJ |
| Device type | Retainer, Screw Expansion, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-05-12 |
| Record revised | 2025-01-03 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2021-04-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 855-924RRC | In distribution | |
| 855-921L | In distribution | |
| 855-918LRCPK | In distribution | |
| 855-927LPK | In distribution | |
| 855-927RRCPK | In distribution | |
| 855-931R | In distribution | |
| 855-918RRCPK | In distribution | |
| 855-924L | In distribution | |
| 855-927RRC | In distribution | |
| 855-924LRCPK | In distribution | |
| 855-927RPK | In distribution | |
| 855-918RPK | In distribution | |
| 855-918R | In distribution | |
| 855-921RRC | In distribution | |
| 855-924RPK | In distribution | |
| 855-918LRC | In distribution | |
| 855-927LRC | In distribution | |
| 855-918RRC | In distribution | |
| 855-921RPK | In distribution | |
| 855-931RPK | In distribution | |
| 855-921LRCPK | In distribution | |
| 855-921RRCPK | In distribution | |
| 855-921LRC | In distribution | |
| 855-924R | In distribution | |
| 855-918LPK | In distribution | |
| 855-927R | In distribution | |
| 855-931LPK | In distribution | |
| 855-921LPK | In distribution | |
| 855-927L | In distribution | |
| 855-927LRCPK | In distribution | |
| 855-921R | In distribution | |
| 855-931L | In distribution | |
| 855-924LPK | In distribution | |
| 855-918L | In distribution | |
| 855-924RRCPK | In distribution | |
| 855-924LRC | In distribution | |
| 855-920 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Leone SPA | Leone SPA | 441 |
| Retainer, Screw Expansion, Orthodontic | Dentaurum GmbH & Co. KG | 243 |
| 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 |
| RMO | RMO | 33 |
| Palatal Arches | American Orthodontics | 28 |
| Morelli | Dental Morelli Ltda. | 28 |
Showing 12 of 295. All products under Retainer, Screw Expansion, Orthodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K912417 | 1991-12-20 |
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.