BioHorizons

Tapered Pro Conical/Tapered Short Conical Radiographic Implant Template

Registry build 21.09.26
70manufacturers in China registered for this device type
1,008catalogue numbers in this listing
2recalls on this 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.

Chinese manufacturers registered for FDA product code NDP
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

Regulatory record for BioHorizons
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

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 numbers for BioHorizons
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

Other products under the same FDA 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.

Recalls referencing this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer