BioHorizons
Tapered Pro Conical/Tapered Short Conical Radiographic Implant Template
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 | Biohorizons Implant Systems Inc., United States |
|---|---|
| FDA product code | NDP |
| Device type | Accessories, Implant, Dental, Endosseous |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | BK120048 |
| Record published | 2016-07-25 |
| Record revised | 2022-09-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-02-24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TSD202510HD | In distribution | |
| 122-125105 | In distribution | |
| PBAH | In distribution | |
| TRYTIM8010 | In distribution | |
| MSTG4 | In distribution | |
| CNIDRL | In distribution | |
| PBRSC | In distribution | |
| PXDCSL | In distribution | |
| SBRP40 | In distribution | |
| MSTG5 | In distribution | |
| CNIDR11 | In distribution | |
| PGRISC | In distribution | |
| ATKG4 | In distribution | |
| ODSRC-P | In distribution | |
| BC2258.43TRY | In distribution | |
| CGS-2828SU | In distribution | |
| CNBP | In distribution | |
| CGS-FP | In distribution | |
| MSTG2 | In distribution | |
| TRYTP3MU | In distribution | |
| CGS-DGB47 | In distribution | |
| TSD2025HD | In distribution | |
| CRICO | In distribution | |
| CLS | In distribution | |
| TSD2037HD | In distribution | |
| CNIC | In distribution | |
| CBDRS | In distribution | |
| IC-SL | In distribution | |
| CGS-3224 | In distribution | |
| TSD202515HD | In distribution | |
| CRTRY17 | In distribution | |
| SBPIC55 | In distribution | |
| TSD2047HD | In distribution | |
| MU-GC | In distribution | |
| ODSICS | In distribution | |
| TDG2058HD | In distribution | |
| TDS42SB | In distribution | |
| DG-GN-25 | In distribution | |
| BDBPZ | In distribution | |
| IL-PT | In distribution | |
| TSD2047SB | In distribution | |
| PBSSB8 | In distribution | |
| MU-PA | In distribution | |
| CGS-5424SU | In distribution | |
| CNCSP | In distribution | |
| TSD4020HD | In distribution | |
| PBSSB11 | In distribution | |
| 122-230 | In distribution | |
| DG-GN-32 | In distribution | |
| D2015Z | In distribution | |
| CRIDH18 | In distribution | |
| 122-12515 | In distribution | |
| TST2038 | In distribution | |
| OD-A | In distribution | |
| TST2034HDSU | In distribution | |
| PYDBP | In distribution | |
| PROID38 | In distribution | |
| TP3IA25 | In distribution | |
| PROIDGY | In distribution | |
| CRIDH | In distribution | |
| CGS-BMC-10 | In distribution | |
| TSKHDUS | In distribution | |
| 5605 | In distribution | |
| TOD2032 | In distribution | |
| TIMD7010XT | In distribution | |
| SYRP40 | In distribution | |
| PROLD5410 | In distribution | |
| TDS32HDSU | In distribution | |
| SYRP55 | In distribution | |
| GD-2024 | In distribution | |
| OD-RC-C | In distribution | |
| CGS-2521 | In distribution | |
| PROPRE47 | In distribution | |
| PGMUBP | In distribution | |
| TSD2047HDSU | In distribution | |
| 2605 | In distribution | |
| TST2058 | In distribution | |
| GD-3224 | In distribution | |
| CNILA25 | In distribution | |
| CRBPP | In distribution | |
| CGS-PBIDR | In distribution | |
| CGS-3728SU | In distribution | |
| TSC2058HD | In distribution | |
| PHYBWSS | In distribution | |
| PADM14 | In distribution | |
| CGS-4124 | In distribution | |
| 144-300 | In distribution | |
| GD-3717 | In distribution | |
| CBDHL | In distribution | |
| CGS-4717SU | In distribution | |
| TSK3500 | In distribution | |
| TSD2028SB | In distribution | |
| TIMD7009XT | In distribution | |
| TRYTIM8007 | In distribution | |
| PSDSR | In distribution | |
| 135-251 | In distribution | |
| PBBAA | In distribution | |
| TSC2034HD | In distribution | |
| ATKG1 | In distribution | |
| CGS-2528SU | In distribution | |
| PROTPPR | In distribution | |
| MDL-SK | In distribution | |
| TIMD8007 | In distribution | |
| TDS42DB | In distribution | |
| 122-100 | In distribution | |
| TSD2025DB | In distribution | |
| TDS54HD | In distribution | |
| CNICO | In distribution | |
| PROLD2510 | In distribution | |
| 134-450 | In distribution | |
| 134-350 | In distribution | |
| 260-220 | In distribution | |
| PXABPC | In distribution | |
| PROLD5412 | In distribution | |
| TSK4000 | In distribution | |
| CGS-DGG20 | In distribution | |
| 244-321 | In distribution | |
| 400-001 | In distribution | |
| DG-GN-41 | In distribution | |
| TSD2032DB | In distribution | |
| TSD2041SB | In distribution | |
| PGIA25 | In distribution | |
| BDTRKZ | In distribution | |
| TIMD8009XT | In distribution | |
| PGTP | In distribution | |
| SYR55 | In distribution | |
| PROLD5409 | In distribution | |
| PROLD4107 | In distribution | |
| GD-2828 | In distribution | |
| TRE46 | In distribution | |
| TD-37 | In distribution | |
| GS-GC-GN | In distribution | |
| 300-350 | In distribution | |
| TD-32 | In distribution | |
| CGS-DGB41 | In distribution | |
| 400-248 | In distribution | |
| GD-2517 | In distribution | |
| HD-MAN | In distribution | |
| PROLD4115 | In distribution | |
| CGS-DGB37 | In distribution | |
| PGTBWSI | In distribution | |
| 260-100 | In distribution | |
| PGNISC | In distribution | |
| CGS-PS6-10 | In distribution | |
| IC-S | In distribution | |
| OD-PI-B | In distribution | |
| 400-050 | In distribution | |
| 243-331 | In distribution | |
| TP3IDRL | In distribution | |
| PBTSB | In distribution | |
| 243-321 | In distribution | |
| CGS-DGB25 | In distribution | |
| TST2046HDSU | In distribution | |
| TDG2034HD | In distribution | |
| CGS3500 | In distribution | |
| TSD2020PD | In distribution | |
| PROLD3712 | In distribution | |
| TSD2037SB | In distribution | |
| TDS32HD | In distribution | |
| TDS41HD | In distribution | |
| CRIDR | In distribution | |
| TSD4047SB | In distribution | |
| TIMD7007 | In distribution | |
| MDLMWZ | In distribution | |
| 135-351 | In distribution | |
| ODSCM | In distribution | |
| PROPRE32 | In distribution | |
| RE-4MM | In distribution | |
| CGS-BTP | In distribution | |
| CRBP | In distribution | |
| PXMUPA | In distribution | |
| MDLRDLZ | In distribution | |
| PROLD2810 | In distribution | |
| CNIDH18 | In distribution | |
| 2620N | In distribution | |
| PD-15 | In distribution | |
| TRYTP3MU17 | In distribution | |
| TP3BPGP | In distribution | |
| PROCDPR | In distribution | |
| GD-2824 | In distribution | |
| PXMUDPC | In distribution | |
| BC2255.33TRY | In distribution | |
| TDS42CB | In distribution | |
| ODS-XH | In distribution | |
| 1430/2021 | In distribution | |
| SBPWSC | In distribution | |
| TSGG3 | In distribution | |
| PBTBWSI | In distribution | |
| SBDCN | In distribution | |
| MDLMMHZ | In distribution | |
| TSD4041HD | In distribution | |
| CGS-3217SU | In distribution | |
| CGS-5417 | In distribution | |
| 144-200 | In distribution | |
| GD-4124 | In distribution | |
| CGS-DH | In distribution | |
| PYWDC | In distribution | |
| CBDRL | In distribution | |
| CGS-4724 | In distribution | |
| BSMTDRT | In distribution | |
| L01033 | In distribution | |
| CBD-33 | In distribution | |
| TSC2046HD | In distribution | |
| TB-BS | In distribution | |
| TST2038HD | In distribution | |
| GD-3221 | In distribution | |
| PROLD5415 | In distribution | |
| PYTSB | In distribution | |
| TIMD7007SU | In distribution | |
| TSD2032HD | In distribution | |
| HW-4MM | In distribution | |
| TYGIDH | In distribution | |
| ODS-HCPM | In distribution | |
| DG-YW-25 | In distribution | |
| CIDSRL | In distribution | |
| 245-321 | In distribution | |
| TST2030HD | In distribution | |
| TSD2047DB | In distribution | |
| TSD4028HD | In distribution | |
| PROGAPR | In distribution | |
| TSGBMC-10 | In distribution | |
| CGS-2524 | In distribution | |
| PHRSR | In distribution | |
| PROLD3215 | In distribution | |
| TOD2047 | In distribution | |
| CGS-3221SU | In distribution | |
| D25Z | In distribution | |
| TSD4032SB | In distribution | |
| 122-12509 | In distribution | |
| PROLD2815 | In distribution | |
| CGS-4728SU | In distribution | |
| TSD2028HD | In distribution | |
| CNBRC | In distribution | |
| TIMD8010XT | In distribution | |
| CNIDH11 | In distribution | |
| 300-354 | In distribution | |
| PBSSB | In distribution | |
| PGWDC | In distribution | |
| CGS-3724SU | In distribution | |
| CRTRYS | In distribution | |
| BSMTDR | In distribution | |
| 300-351 | In distribution | |
| GD-4528 | In distribution | |
| MDLSPDLZ | In distribution | |
| PROLD3709 | In distribution | |
| TST2058HD | In distribution | |
| TSGB1 | In distribution | |
| CGS-3721SU | In distribution | |
| TSD2041DB | In distribution | |
| PXMUTCS | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Astra Tech Implant System® | Dentsply Implants Manufacturing GmbH | 596 |
Showing 12 of 7,548. All products under Accessories, Implant, Dental, Endosseous
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-06-03 | Not classified | Other | The product labeled as a profile abutment for Cement contained a Straight Permucosal Ext, 5mm x 3mm. | 23 units | 2005-08-11 |
| 2005-06-03 | Not classified | Other | The product labeled as a Straight Permucosal Ext, 5mm x 3mm contained a profile abutment for Cement. | 5 units | 2005-08-11 |
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.