BioHorizons
BioHorizons Multi-unit 30° Angled Abutment for CONELOG, Ø3.8/4.3 x 4mm (GH), Type B
15manufacturers in China registered for this device type
833catalogue numbers in this listing
12510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 12 |
| DTS Digital Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 11 |
| KTJ Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shimmer Computerized Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 10 |
| Zhuhai Crystal Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 9 |
| NEW Perfect Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| CBD Dental LAB, Inc | Shenzhen | Guangdong | Manufacturer | 11 |
Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous
Record
| Listed by | Biohorizons Implant Systems Inc., United States |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K960026 |
| Record published | 2015-09-18 |
| Record revised | 2023-12-20 (version 8) |
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 | 2025-06-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 234-210 | In distribution | |
| PXAS25 | In distribution | |
| MLHCZ | In distribution | |
| C2273.3310 | In distribution | |
| TP3MU303 | In distribution | |
| TP3ODS1 | In distribution | |
| PBODS2 | In distribution | |
| PGCMAW | In distribution | |
| CN30MU2 | In distribution | |
| PGCMAX | In distribution | |
| TP3TB | In distribution | |
| PBSSEA3 | In distribution | |
| TP3CMA | In distribution | |
| PBSAEA | In distribution | |
| CR17MU3 | In distribution | |
| PGODS1 | In distribution | |
| TP3EWHA3 | In distribution | |
| TP3SAEA | In distribution | |
| C2273.4330 | In distribution | |
| PBODSK2 | In distribution | |
| CM-YW | In distribution | |
| TP3ODSK1 | In distribution | |
| PYHA18L | In distribution | |
| PB5518L | In distribution | |
| PYNHA2 | In distribution | |
| TP3ETNL | In distribution | |
| PYTBL | In distribution | |
| SBAA | In distribution | |
| PGDPCA | In distribution | |
| C2273.5050 | In distribution | |
| CR15A1W | In distribution | |
| PYETHL | In distribution | |
| TP3MU172 | In distribution | |
| CA-GY-A | In distribution | |
| 212-404 | In distribution | |
| C2273.4310 | In distribution | |
| PGHYB | In distribution | |
| PYCMA | In distribution | |
| SYHA20 | In distribution | |
| MLTICOZ | In distribution | |
| PBCMA | In distribution | |
| CRHA6EW | In distribution | |
| PGETHL | In distribution | |
| TP3MU2 | In distribution | |
| CRTNA3 | In distribution | |
| PY5528L | In distribution | |
| SYAA | In distribution | |
| PXMUPSR | In distribution | |
| CRCC | In distribution | |
| PBSSHP1 | In distribution | |
| PGBA5 | In distribution | |
| TP3RATA | In distribution | |
| CRSA1 | In distribution | |
| PGSSHP1T | In distribution | |
| PYCAN | In distribution | |
| PXAS | In distribution | |
| TP3ODS2 | In distribution | |
| PYODS3 | In distribution | |
| C2273.4340 | In distribution | |
| PBCMAW | In distribution | |
| PGODS6 | In distribution | |
| PGSSHM2 | In distribution | |
| PBSREA | In distribution | |
| CRTE0T | In distribution | |
| PXMUPSR25 | In distribution | |
| PYMU174 | In distribution | |
| TP3PTC | In distribution | |
| PGAFS25 | In distribution | |
| PGMU4L | In distribution | |
| PGNHA5L | In distribution | |
| PGMU172 | In distribution | |
| PXMUPSR1 | In distribution | |
| CRTE2T | In distribution | |
| TP3SSHA1 | In distribution | |
| SBHA40 | In distribution | |
| PYODS2 | In distribution | |
| TP3TTN | In distribution | |
| PYSEAL | In distribution | |
| TP3MU1 | In distribution | |
| 236-227 | In distribution | |
| MDLTICOZ | In distribution | |
| CRTBI | In distribution | |
| CR15A3 | In distribution | |
| PBAFS15 | In distribution | |
| PXABSL | In distribution | |
| C2273.5010 | In distribution | |
| SYHYB | In distribution | |
| CNODS4 | In distribution | |
| PXMUPSD5 | In distribution | |
| PGMU303 | In distribution | |
| TP3MU2L | In distribution | |
| CRSSHP1T | In distribution | |
| PGODSK6 | In distribution | |
| MU-YW-S4 | In distribution | |
| CRSA3 | In distribution | |
| PGODSK1 | In distribution | |
| PGAFS5 | In distribution | |
| CRSSHA1 | In distribution | |
| PYSEA | In distribution | |
| 50054 | In distribution | |
| PBSEA3L | In distribution | |
| MU-YW-S3 | In distribution | |
| BC2259.4340 | In distribution | |
| HA-YW-R5 | In distribution | |
| TP3NHA2 | In distribution | |
| MU-CCC | In distribution | |
| PYODS1 | In distribution | |
| PYACA | In distribution | |
| SYHA40 | In distribution | |
| PGSSHP1 | In distribution | |
| PBMU1 | In distribution | |
| PB4008L | In distribution | |
| PGMU305 | In distribution | |
| OD-YW-5 | In distribution | |
| PBWHA3 | In distribution | |
| HA-GY-R5 | In distribution | |
| CNTEA | In distribution | |
| TP3PTCN | In distribution | |
| 2905 | In distribution | |
| PGODS4 | In distribution | |
| PBMU3 | In distribution | |
| BC2258.4340 | In distribution | |
| PXMUPSS | In distribution | |
| PYMU2 | In distribution | |
| TP3SCA3 | In distribution | |
| CRHA6W | In distribution | |
| PGODSK2 | In distribution | |
| PBNEA | In distribution | |
| PXPAS | In distribution | |
| PYMU172 | In distribution | |
| MU-PSL | In distribution | |
| PYSSHA2 | In distribution | |
| PBRHA5 | In distribution | |
| CNODS2 | In distribution | |
| CN17MU2 | In distribution | |
| PGHA28L | In distribution | |
| CR20A3 | In distribution | |
| PGHA08L | In distribution | |
| TP3ACA | In distribution | |
| BC2258.3330 | In distribution | |
| C2273.3340 | In distribution | |
| 212-503 | In distribution | |
| PYTTH | In distribution | |
| PGBPA | In distribution | |
| TP3SEAL | In distribution | |
| CNTNA4 | In distribution | |
| 1031/2907 | In distribution | |
| PYMU3 | In distribution | |
| TP3ODS3 | In distribution | |
| MU-YW-S2 | In distribution | |
| CNTN2 | In distribution | |
| CRODS3 | In distribution | |
| CRTEA | In distribution | |
| CRTNA4 | In distribution | |
| OD-YW-2 | In distribution | |
| CRSSHA1T | In distribution | |
| PB5508L | In distribution | |
| C2273.4350 | In distribution | |
| PYSSEA3 | In distribution | |
| TP3ODS0 | In distribution | |
| TP3HYB | In distribution | |
| PY4008L | In distribution | |
| PGRAA | In distribution | |
| CC-GY-H | In distribution | |
| TB-GY-N | In distribution | |
| CNSSHM2T | In distribution | |
| PBSSHP2T | In distribution | |
| MU-YW-174 | In distribution | |
| PBSEA | In distribution | |
| PXABCC | In distribution | |
| BC2256.3320 | In distribution | |
| PYMU3L | In distribution | |
| CNTEA4 | In distribution | |
| PBCMAWX | In distribution | |
| PGBPAL | In distribution | |
| TP3CMAWX | In distribution | |
| PBNHA3L | In distribution | |
| PGSSHP2T | In distribution | |
| 234-214 | In distribution | |
| TP3CMAW | In distribution | |
| PBNHA3 | In distribution | |
| PG4008L | In distribution | |
| PGODSK0 | In distribution | |
| 203-311 | In distribution | |
| 212-504 | In distribution | |
| PYWHA5 | In distribution | |
| CA-YW-S | In distribution | |
| CRSSHP1 | In distribution | |
| PBPTCN | In distribution | |
| CA-YW-A20 | In distribution | |
| PGODS2 | In distribution | |
| MDLSAPZ | In distribution | |
| CA-GY-S3 | In distribution | |
| 50052 | In distribution | |
| 2031/2907 | In distribution | |
| TP3ETHL | In distribution | |
| C2273.3850 | In distribution | |
| PGMU174 | In distribution | |
| OD-GY-5 | In distribution | |
| PXMUAS25 | In distribution | |
| TP3CAH | In distribution | |
| PGCMA | In distribution | |
| PBNHA1 | In distribution | |
| CRODS2 | In distribution | |
| PGMU5 | In distribution | |
| PBSEA3 | In distribution | |
| PXABS | In distribution | |
| BC2257.3320 | In distribution | |
| MU-GY-304 | In distribution | |
| PYMU173 | In distribution | |
| PGSEAL | In distribution | |
| SBCAN | In distribution | |
| MU-PSR | In distribution | |
| CNSA2 | In distribution | |
| PYAEAL | In distribution | |
| 204-411 | In distribution | |
| BC2259.3320 | In distribution | |
| SBHA20 | In distribution | |
| CRSSHA2 | In distribution | |
| PGSEA | In distribution | |
| PBODS6 | In distribution | |
| CR30MU2 | In distribution | |
| PYRHA3L | In distribution | |
| SBHYB | In distribution | |
| C2273.3330 | In distribution | |
| CAS25 | In distribution | |
| SYAP55 | In distribution | |
| TP3SCA | In distribution | |
| PG5528L | In distribution | |
| CR20A1 | In distribution | |
| PYMU304 | In distribution | |
| CA-YW-A | In distribution | |
| PYODSK5 | In distribution | |
| PGTTH | In distribution | |
| CRTBIV | In distribution | |
| PBMU173 | In distribution | |
| CR20A1W | In distribution | |
| PYMU2L | In distribution | |
| C2273.5040 | In distribution | |
| TP3SSHA1T | In distribution | |
| CRSSHM1 | In distribution | |
| PYSEA3 | In distribution | |
| TP3BPA | In distribution | |
| PXMUPSA25 | In distribution | |
| PGMU2L | In distribution | |
| TB-YW-N | In distribution | |
| PBBA3 | In distribution | |
| BC2255.4340 | In distribution | |
| CNHA6 | In distribution | |
| BC2255.3320 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MEDENTiKA | Medentika GmbH | 2,553 |
| LW Vis Abutment | Ossvis Co., Ltd. | 2,520 |
| Dess dental smart solutions | Terrats Medical SL | 1,715 |
| Locator | Zest Anchors, LLC | 1,643 |
| NobelProcera® | Nobel Biocare AB | 1,526 |
| Azure | Terrats Medical SL | 1,360 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 1,308 |
| LW Vis Abutment SET | Ossvis Co., Ltd. | 1,260 |
| Abutment, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,240 |
| Healing Abutment | Megagen Implant Co., Ltd. | 1,218 |
| Chaorum Implant System | Medimecca Co Ltd | 1,084 |
| OT Equator | Rhein 83 SRL | 1,051 |
Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260061 | 2026-06-26 |
| K243521 | 2025-05-01 |
| K240531 | 2024-07-30 |
| K203252 | 2021-03-16 |
| K180998 | 2018-09-28 |
| K151621 | 2016-01-13 |
| K103291 | 2011-11-04 |
| K103691 | 2011-11-03 |
| K100985 | 2010-09-09 |
| K061567 | 2006-11-22 |
| K053099 | 2006-02-14 |
| K022795 | 2002-08-30 |
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 |
|---|---|---|---|---|---|---|
| DDS Lab | 510(k) number | 2024-12-06 | Class II | Component design/selection | Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affix | 11,259 |
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.