Prima
42 catalogue numbers from 45294K, listed by Keystone Dental Inc., United States, under Accessories, Implant, Dental, Endosseous. 70 manufacturers in China are registered for this product code.
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 | Keystone Dental Inc., United States |
|---|---|
| FDA product code | NDP |
| Device type | Accessories, Implant, Dental, Endosseous |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K051614 |
| Record published | 2019-05-08 |
| Record revised | 2025-12-01 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45294K | In distribution | |
| 15273K | In distribution | |
| 45293K | In distribution | |
| 15266K | In distribution | |
| 15287K | In distribution | |
| 15224K | In distribution | |
| 15686K | In distribution | |
| 15290K | In distribution | |
| 15284K | In distribution | |
| 15277K | In distribution | |
| 15288K | In distribution | |
| 15684K | In distribution | |
| 15283K | In distribution | |
| 15274K | In distribution | |
| 15289K | In distribution | |
| 45041K | In distribution | |
| 15286K | In distribution | |
| 15685K | In distribution | |
| 15271K | In distribution | |
| 15270K | In distribution | |
| ISS1111K | In distribution | |
| 15272K | In distribution | |
| 15720K | In distribution | |
| 15226K | In distribution | |
| 15268K | In distribution | |
| ISS1100K | In distribution | |
| 45311K | In distribution | |
| 15276K | In distribution | |
| 15267K | In distribution | |
| E40100 | In distribution | |
| 45045K | In distribution | |
| ISS1112K | In distribution | |
| L1702-01K | In distribution | |
| 15282K | In distribution | |
| 15721K | In distribution | |
| 15275K | In distribution | |
| ISS1102K | In distribution | |
| ISS1101K | In distribution | |
| L1407K | In distribution | |
| 15683K | In distribution | |
| 15269K | In distribution | |
| 40007K | 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Keystone Dental Inc. | 510(k) number | 2013-03-11 | Class II | Packaging process control | Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled | 120 units | 2013-09-26 |
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 | Closed |
|---|---|---|---|---|---|
| 2018-01-24 | Class II | Under Investigation by firm | The cutting edge of tissue punches may be potentially damaged with small dents and nicks. | 101 | 2018-07-30 |
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.