BioHorizons
Tapered Internal Plus Implant, 4.6mm x 10.5mm, 3.5 Platform, Laser-Lok
7manufacturers in China registered for this device type
350catalogue numbers in this listing
26510(k) clearances naming this product code
12recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Basic (Chengdu) Medical Device Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Dongguan Xinlonghong Hardware Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| BIO Concept Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Biohorizons Implant Systems Inc., United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K172576 |
| Record published | 2017-12-07 |
| Record revised | 2023-12-20 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2024-08-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TSL4607 | In distribution | |
| MLW3011Z | In distribution | |
| CTR3818R | In distribution | |
| CTA4618 | In distribution | |
| TLX3815 | In distribution | |
| TRX5810 | In distribution | |
| TRX4610 | In distribution | |
| TTLG4612 | In distribution | |
| 3DS4215 | In distribution | |
| TRXP4609 | In distribution | |
| CTA5215 | In distribution | |
| TSL4606 | In distribution | |
| BTR4218 | In distribution | |
| IL-3810 | In distribution | |
| CTR3809 | In distribution | |
| TLXP4610 | In distribution | |
| TTLG4607 | In distribution | |
| 3DS4209 | In distribution | |
| IL-3815 | In distribution | |
| TP3CC | In distribution | |
| TLX3810 | In distribution | |
| TRX3815 | In distribution | |
| TTLB5812 | In distribution | |
| TLX4618 | In distribution | |
| TLX3809 | In distribution | |
| IL-3310 | In distribution | |
| MDL2013SZ | In distribution | |
| TRXP4607 | In distribution | |
| TLX4612 | In distribution | |
| PTG4218 | In distribution | |
| CTR3309 | In distribution | |
| CS-YW | In distribution | |
| TLXP5807 | In distribution | |
| TIM8010 | In distribution | |
| CTA3810R | In distribution | |
| TLX3012 | In distribution | |
| TLR5809 | In distribution | |
| TLXP5812 | In distribution | |
| CTA3810 | In distribution | |
| CTR4607 | In distribution | |
| CTA3809 | In distribution | |
| CTA4210 | In distribution | |
| MDL2015Z | In distribution | |
| TLR5810 | In distribution | |
| TRX4612 | In distribution | |
| BTR4610 | In distribution | |
| TRX5807 | In distribution | |
| TLX4610 | In distribution | |
| BTA4618 | In distribution | |
| TLX4607 | In distribution | |
| MLW3015Z | In distribution | |
| TRXP3809 | In distribution | |
| BTR4212 | In distribution | |
| IL-4212 | In distribution | |
| TRX4607 | In distribution | |
| BTR3815 | In distribution | |
| TLX5812 | In distribution | |
| CTR3809R | In distribution | |
| CTA4209 | In distribution | |
| TRX4615 | In distribution | |
| 3DS4210 | In distribution | |
| CTR5209 | In distribution | |
| BTR4609 | In distribution | |
| MDL2515SZ | In distribution | |
| TRX3412 | In distribution | |
| BTR4209 | In distribution | |
| CTA3309 | In distribution | |
| CTA5212 | In distribution | |
| CTA5207 | In distribution | |
| CTA4609 | In distribution | |
| IL-5009 | In distribution | |
| TRX3810 | In distribution | |
| BTR4615 | In distribution | |
| CTA4610 | In distribution | |
| CTR4618 | In distribution | |
| TMR5809 | In distribution | |
| CTR3810R | In distribution | |
| TRXP5812 | In distribution | |
| BTA3809 | In distribution | |
| TLX3010 | In distribution | |
| MDL2018Z | In distribution | |
| BTR5212 | In distribution | |
| TLR3812 | In distribution | |
| TRX4609 | In distribution | |
| TMR5807 | In distribution | |
| BTA3810 | In distribution | |
| TTLY3809 | In distribution | |
| CTR3815R | In distribution | |
| CTA3312 | In distribution | |
| TTLB5809 | In distribution | |
| CTR3315 | In distribution | |
| BTA3818 | In distribution | |
| TLR4612 | In distribution | |
| TMR3810 | In distribution | |
| TRXP4615 | In distribution | |
| MDL2011SZ | In distribution | |
| TMR4607 | In distribution | |
| BTA4615 | In distribution | |
| BTR3810 | In distribution | |
| TRX3410 | In distribution | |
| TRXP3812 | In distribution | |
| IL-3809 | In distribution | |
| BTR5209 | In distribution | |
| PBCC | In distribution | |
| BTA3815 | In distribution | |
| CTR4215 | In distribution | |
| BTA4609 | In distribution | |
| MDL2511Z | In distribution | |
| BTA4212 | In distribution | |
| CTR4212 | In distribution | |
| MDL2011Z | In distribution | |
| TLXP3815 | In distribution | |
| MDL2513Z | In distribution | |
| CTA4607 | In distribution | |
| TLX5810 | In distribution | |
| TMR4610 | In distribution | |
| BTR4612 | In distribution | |
| TIM7010 | In distribution | |
| CTR3818 | In distribution | |
| TSL5806 | In distribution | |
| BTA5215 | In distribution | |
| CTA3318 | In distribution | |
| MDL2510SZ | In distribution | |
| CTA5209 | In distribution | |
| TMR4609 | In distribution | |
| MDL2010Z | In distribution | |
| IL-5007 | In distribution | |
| BTR4210 | In distribution | |
| TLXP5810 | In distribution | |
| BTA5210 | In distribution | |
| PYCC | In distribution | |
| TLXP3812 | In distribution | |
| TLX3418 | In distribution | |
| TLX3410 | In distribution | |
| CTR5210 | In distribution | |
| CTA5210 | In distribution | |
| TLX3409 | In distribution | |
| TIM8007 | In distribution | |
| MDL2510Z | In distribution | |
| TLXP3810 | In distribution | |
| MLW3013Z | In distribution | |
| TLR3815 | In distribution | |
| CTA4218 | In distribution | |
| MDL2013Z | In distribution | |
| BTA5212 | In distribution | |
| TIM7009 | In distribution | |
| IL-4209 | In distribution | |
| TLR4609 | In distribution | |
| TRX5812 | In distribution | |
| IL-5012 | In distribution | |
| 104-900 | In distribution | |
| TLXP3809 | In distribution | |
| MDL2513SZ | In distribution | |
| BTA4210 | In distribution | |
| 3DS4212 | In distribution | |
| BTR4618 | In distribution | |
| CTA4615 | In distribution | |
| IL-3315 | In distribution | |
| MDL2010SZ | In distribution | |
| TTLB5807 | In distribution | |
| 106-900 | In distribution | |
| CTA3315 | In distribution | |
| CTR4610 | In distribution | |
| BTR5215 | In distribution | |
| CTA3809R | In distribution | |
| 105-900 | In distribution | |
| PXMUCC | In distribution | |
| CTR3310 | In distribution | |
| MLW3010Z | In distribution | |
| TLX5815 | In distribution | |
| TLXP5809 | In distribution | |
| TLX5807 | In distribution | |
| MDL2518Z | In distribution | |
| IL-5015 | In distribution | |
| CTA3818 | In distribution | |
| BTA5209 | In distribution | |
| CTR3812 | In distribution | |
| TTLG4609 | In distribution | |
| BTA4610 | In distribution | |
| TLXP4615 | In distribution | |
| TRX3409 | In distribution | |
| TRXP3815 | In distribution | |
| MDL2015SZ | In distribution | |
| TRX3809 | In distribution | |
| BTR5210 | In distribution | |
| TMR4615 | In distribution | |
| TLX4615 | In distribution | |
| TMR4612 | In distribution | |
| TLR3809 | In distribution | |
| TIM8009 | In distribution | |
| TLX3818 | In distribution | |
| 103-900 | In distribution | |
| TTLY3010 | In distribution | |
| TMR3815 | In distribution | |
| TMR5810 | In distribution | |
| CTR4210 | In distribution | |
| TLR5812 | In distribution | |
| TRXP4612 | In distribution | |
| TMR5815 | In distribution | |
| TLXP4609 | In distribution | |
| BTA4218 | In distribution | |
| TRX5815 | In distribution | |
| TLR5807 | In distribution | |
| BTA4209 | In distribution | |
| TLXP5815 | In distribution | |
| TTLG4610 | In distribution | |
| CTA3818R | In distribution | |
| CTA4612 | In distribution | |
| TRX3812 | In distribution | |
| MDL2515Z | In distribution | |
| PTG4215 | In distribution | |
| CTR4209 | In distribution | |
| IL-4210 | In distribution | |
| CTA4215 | In distribution | |
| CTR3812R | In distribution | |
| CTR5207 | In distribution | |
| CTR4615 | In distribution | |
| TIM7007 | In distribution | |
| CS-GY | In distribution | |
| TLR4607 | In distribution | |
| TLX4609 | In distribution | |
| BTA3812 | In distribution | |
| CTA3815R | In distribution | |
| TRX3415 | In distribution | |
| CTR4207 | In distribution | |
| TRXP4610 | In distribution | |
| CTA4207 | In distribution | |
| TRXP5807 | In distribution | |
| BTR3812 | In distribution | |
| BTA4215 | In distribution | |
| CTA4212 | In distribution | |
| TLXP4612 | In distribution | |
| CTA3812 | In distribution | |
| TLXP4607 | In distribution | |
| TRXP3810 | In distribution | |
| CTA3310 | In distribution | |
| TSL5807 | In distribution | |
| IL-5010 | In distribution | |
| MDL2511SZ | In distribution | |
| TLR4615 | In distribution | |
| TMR3809 | In distribution | |
| CTA3812R | In distribution | |
| BTR4215 | In distribution | |
| TLX3812 | In distribution | |
| TRX5809 | In distribution | |
| TRXP5809 | In distribution | |
| TRXP5815 | In distribution | |
| CTR4609 | In distribution | |
| TLX3015 | In distribution | |
| TLX3412 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 920 |
| Osstem Implant System | Osstem Implant Co., Ltd. | 788 |
| Magicore | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 744 |
| Implant, Endosseous, Root-Form | Southern Implants (PTY) Ltd | 608 |
| ITL Dental | Emery Enterprises Inc. | 603 |
| Magicore S | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 560 |
| Friadent® | Dentsply Implants Manufacturing GmbH | 525 |
| Sphero Block Normo | Rhein 83 SRL | 489 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 483 |
| KJ Mini Implant System | Kjmeditech.co., Ltd. | 448 |
| Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 418 |
| Leone SPA | Leone SPA | 404 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240187 | 2024-06-05 |
| K223697 | 2023-10-13 |
| K182070 | 2018-10-10 |
| K172576 | 2017-11-22 |
| K143022 | 2015-01-08 |
| K121787 | 2012-09-05 |
| K093321 | 2010-04-02 |
| K081818 | 2008-11-13 |
| K073282 | 2008-02-15 |
| K073268 | 2008-02-08 |
| K071638 | 2007-10-10 |
| K053152 | 2005-12-02 |
| K052419 | 2005-09-20 |
| K042429 | 2004-09-16 |
| K041938 | 2004-07-22 |
| K032351 | 2003-10-21 |
| K030463 | 2003-02-26 |
| K020645 | 2002-03-15 |
| K020133 | 2002-01-25 |
| K010458 | 2001-05-10 |
| K990277 | 1999-04-09 |
| K980374 | 1998-03-04 |
| K972313 | 1997-09-16 |
| K964330 | 1997-01-17 |
| K963951 | 1996-12-31 |
| K960026 | 1996-03-28 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biohorizons Implant Systems Inc. | 510(k) number | 2015-10-30 | Class II | Employee error | An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging. | 32 units | 2016-02-04 |
| Biohorizons Implant Systems Inc. | 510(k) number | 2015-04-16 | Class II | Process control | BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium. | 48 units | 2015-08-07 |
| Biohorizons Implant Systems Inc. | 510(k) number | 2013-12-10 | Class II | Mixed-up of materials/components | The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length. | 119 units | 2014-03-28 |
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2012-11-19 | Class II | Component design/selection | The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. | 174 units | 2013-09-24 |
| 2012-11-19 | Class II | Component design/selection | The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. | 1246 units | 2013-09-24 |
| 2010-09-07 | Not classified | Other | Healing abutment may not fully seat on the implant. | 396 | 2010-12-13 |
| 2007-04-18 | Not classified | Other | Dental implant system is missing ball attachment system. | 34 units | 2007-08-11 |
| 2007-03-12 | Not classified | Other | Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear. | 495 units | 2007-09-04 |
| 2007-03-12 | Not classified | Other | Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear. | 436 units | 2007-09-04 |
| 2007-03-12 | Not classified | Other | Premature wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear. | 363 units | 2007-09-04 |
| 2007-03-12 | Not classified | Other | Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear. | 72 units | 2007-09-04 |
| 2005-12-28 | Not classified | Other | Dental implants were distributed which lacked the proper instruments for implantation. | 470 units | 2007-08-11 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P800035 | 2001-10-04 | PERI-OSS | Curasan AG |
| P860012 | 1988-10-28 | ALVEOFORM TM BIOGRAFT | Collagen Corp. |
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.