PrimeLoc
Abutment Retention Sleeve, 20 Pack, Packaged, Primeloc Attachment System
37manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (9), Guangdong (5), Zhejiang (5). 8 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 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Fomed Industries Inc | Qian Jiang | Hubei | Contract manufacturer | 19 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Forefront (Xiamen) Medical Devices Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
Showing 12 of 37. All 37 manufacturers in China registered for Accessories, Retractor, Dental
Record
| Listed by | IPB Inc, United States |
|---|---|
| FDA product code | EIF |
| Device type | Accessories, Retractor, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-17 |
| Record revised | 2021-09-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LOC50070 | In distribution | |
| LOC50047-20 | In distribution | |
| LOC50065-4 | In distribution | |
| LOC50060-20 | In distribution | |
| LOC50042 | In distribution | |
| LOC50064-20 | In distribution | |
| LOC50045 | In distribution | |
| LOC50060-4 | In distribution | |
| LOC50065-20 | In distribution | |
| LOC50075 | In distribution | |
| LOC50047-4 | In distribution | |
| LOC50064-20 | In distribution | |
| LOC50040 | In distribution | |
| LOC50071 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Perfit OneML | Vatech mcis Co., Ltd. | 121 |
| Perfit ZR | Vatech mcis Co., Ltd. | 108 |
| OSE | Orthodontic Supply & Equipment Co., Inc. | 36 |
| Sure-endo | Sure Dent Corporation | 24 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 23 |
| Kohdent | Kohler Medizintechnik GmbH | 19 |
| Henry Schein | Henry Schein, Inc. | 19 |
| House Brand Dentistry | Frontier Dental Supply Inc | 16 |
| Dentech | Dentech Corp. | 12 |
| Ceka & Preci-Line Attachments | Alphadent Co., Ltd. | 10 |
| Intraoral Cheek Retractors | Ortho Technology, Inc. | 9 |
| DCI | DCI International, LLC | 7 |
Showing 12 of 152. All products under Accessories, Retractor, Dental
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.