Glidewell IH™
Glidewell IH™ Multi-Unit Impression Coping, Open-Tray, with Guide Pin .050" Hex
70manufacturers in China registered for this device type
73catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (28), Jiangsu (9), Zhejiang (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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Xiamen Yizhou IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 10 |
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
Showing 12 of 70. All 70 manufacturers in China registered for Accessories, Implant, Dental, Endosseous
Record
| Listed by | Prismatik Dentalcraft, Inc., United States |
|---|---|
| FDA product code | NDP |
| Device type | Accessories, Implant, Dental, Endosseous |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-06-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 70-1071-SRG0442 | In distribution | ||
| 70-1071-SRG0441 | In distribution | ||
| 70-1071-SRG0444 | In distribution | ||
| 70-1072-PRC0084 | In distribution | ||
| 70-1071-SRG0447 | In distribution | ||
| 70-1073-PRA0134 | In distribution | ||
| 70-1072-PRC0085 | In distribution | ||
| 70-1195-PRC0002 | In distribution | ||
| 70-1072-PRC0069 | In distribution | ||
| 70-1073-PRA0135 | In distribution | ||
| 70-1074-PRS0101 | In distribution | ||
| 70-1072-PRC0091 | In distribution | ||
| 70-1071-SRG0438 | In distribution | ||
| 70-1072-PRC0068 | In distribution | ||
| 70-1072-PRC0070 | In distribution | ||
| 70-1072-PRC0073 | In distribution | ||
| 70-1072-PRC0076 | In distribution | ||
| 70-1071-SRG0445 | In distribution | ||
| 70-1071-SRG0429 | In distribution | ||
| 70-1071-SRG0433 | In distribution | ||
| 70-1071-SRG0436 | In distribution | ||
| 70-1073-PRA0130 | In distribution | ||
| 70-1074-PRS0099 | In distribution | ||
| 70-1072-PRC0072 | In distribution | ||
| 70-1072-PRC0075 | In distribution | ||
| 70-1074-PRS0098 | In distribution | ||
| 70-1072-PRC0089 | 5 | In distribution | |
| 70-1195-PRC0003 | In distribution | ||
| 70-1071-SRG0422 | In distribution | ||
| 70-1073-PRA0132 | In distribution | ||
| 70-1074-PRS0096 | In distribution | ||
| 70-1074-PRS0104 | In distribution | ||
| 70-1071-SRG0443 | In distribution | ||
| 70-1071-SRG0425 | In distribution | ||
| 70-1071-SRG0423 | In distribution | ||
| 70-1071-SRG0434 | In distribution | ||
| 70-1071-SRG0421 | In distribution | ||
| 70-1071-SRG0432 | In distribution | ||
| 70-1072-PRC0092 | In distribution | ||
| 70-1071-SRG0427 | In distribution | ||
| 70-1072-PRC0074 | In distribution | ||
| 70-1071-SRG0431 | In distribution | ||
| 70-1074-PRS0100 | In distribution | ||
| 70-1072-PRC0082 | In distribution | ||
| 70-1073-PRA0136 | In distribution | ||
| 70-1073-PRA0131 | In distribution | ||
| 70-1071-SRG0435 | In distribution | ||
| 70-1071-SRG0426 | In distribution | ||
| 70-1074-PRS0095 | In distribution | ||
| 70-1072-PRC0088 | 5 | In distribution | |
| 70-1072-PRC0083 | In distribution | ||
| 70-1072-PRC0078 | In distribution | ||
| 70-1074-PRS0102 | In distribution | ||
| 70-1072-PRC0080 | In distribution | ||
| 70-1071-SRG0428 | In distribution | ||
| 70-1071-SRG0424 | In distribution | ||
| 70-1072-PRC0071 | In distribution | ||
| 70-1195-PRC0001 | In distribution | ||
| 70-1072-PRC0077 | In distribution | ||
| 70-1074-PRS0103 | In distribution | ||
| 70-1073-PRA0129 | In distribution | ||
| 70-1072-PRC0081 | In distribution | ||
| 70-1071-SRG0440 | In distribution | ||
| 70-1073-PRA0133 | In distribution | ||
| 70-1071-SRG0437 | In distribution | ||
| 70-1073-PRA0137 | In distribution | ||
| 70-1074-PRS0097 | In distribution | ||
| 70-1071-SRG0439 | In distribution | ||
| 70-1071-SRG0430 | In distribution | ||
| 70-1072-PRC0079 | In distribution | ||
| 70-1195-PRC0004 | In distribution | ||
| 70-1072-PRC0090 | In distribution | ||
| 70-1071-SRG0446 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Accessories, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,379 |
| Accessories, Implant, Dental, Endosseous | Institut Straumann AG | 1,320 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 1,112 |
| Inclusive | Prismatik Dentalcraft, Inc. | 1,045 |
| Medentika | Medentika GmbH | 1,042 |
| BioHorizons | Biohorizons Implant Systems Inc. | 1,008 |
| IPD | Implant Protesis Dental 2004 SL | 998 |
| Klockner | Soadco, S.L. | 995 |
| Dynamic Abutment Solutions | Talladium España, SL | 877 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 738 |
| Nobel Biocare® | Nobel Biocare AB | 703 |
| MIS | MIS Implants Technologies Ltd. | 615 |
Showing 12 of 7,548. All products under Accessories, Implant, Dental, Endosseous
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-04-14 | Class II | Process control | Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside. | 15 units |
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.