FDA Registration Active 🇮🇱 Israel

BH-1004

Reg #: 3010393542 · FEI: 3010393542 · Expires 2025
Products
2
Proprietary Names
455
Establishment Types
2
Classifications
2

Registration Details

Registration Name
BHI Implants
Registration Number
3010393542
FEI Number
3010393542
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Hamal 2
City
Afula Northern
Country
IL

Regulatory Submissions

510(k) Number
K103280

Owner / Operator

Firm Name
BHI Implant l Ltd.
Operator Number
10044723
Address
2 Hamal Street, POB 1063,Industrial Park
City
Afula
State
Northern
Postal Code
1857107
Country
IL
Correspondent
Asaf Feuerstein

Products

Device Name Product Code
Abutment, Implant, Dental, Endosseous NHA
Implant, Endosseous, Root-Form DZE

Proprietary Names

BH-1004 BH-D508 BH-AA02 BH-SA06 BH-2512 BH-D311 BH-D613 BH-SA13 BH-2509A BH-1003 BH-1512 BH-1002 BH-1509C BH-D308 BH-D516 BH-D416 BH-AA03 BH-SA08 BH-1502A BH-D413 BH-AA04 BH-D410 BH-D313 BH-1503A BH-D513 BH-D316 BH-1501A BH-D616 BH-D610 BH-D608 BH-1001 BH-2509 BH-1509 BH-D310 BH-1005 BH-D611 BH-D511 BH-D408 BH-D411 BH-C413 BH-1504A BH-PS06 BH-1006 BH-D510 BH-AA01 BH-SAR1 BH-C610 BH-HCS6 BH-S310 BH-2503A BH-HCE7 BH-SAT2 BH-2502A BH-2501A BH-C511 BH-C516 BH-C510 BH-HCW4 BH-HCW3 BH-C313 BH-HCE3 BH-C308 BH-SH508 BH-C408 BH-SH408 BH-C311 BH-C316 BH-HCW5 BH-C416 BH-SAR4 BH-SAR3 BH-2506 BH-C608 BH-HCE6 BH-SH411 BH-SH410 BH-SAS2 BH-SH316 BH-SAT1 BH-PS05 BH-SH513 BH-SH510 BH-SH613 BH-C611 BH-SA12 BH-HCS4 BH-SAS1 BH-C508 BH-1507 BH-HCS2 BH-S313 BH-C513 BH-SAR2 BH-HCS3 BH-2504A BH-HCE4 BH-HCE2 BH-C613 BH-BC00 BH-HCE5 BH-S316 BH-C310 BH-C616 BH-CS10 BH-HCS5 BH-C411 BH-SH516 BH-SH610 BH-S308 BH-S311 BH-SH310 BH-SH616 BH-SAS3 BH-SH611 BH-SH608 BH-C410 BH-HCS7 BH-SH308 BH-SH311 BH-SH413 BH-SH416 BH-SH313 BH-SH511 BH-BTBT4 BH-BTBT3 BH-AABT0 BH-AABT4 BH-BTBT1 BH-AABT5 BH-BTBT2 BH-CABT1 BH-AABT1 BH-AABT3 BH-BTBT5 BH-MU00H2 BH-MU00H3 BH-AABT6 BH-IB17 BH-CABT6 BH-IB29 BH-BABT0 BH-BTBT6 BH-MUSS BH-CABT3 BH-MU00H4 BH-AABT2 BH-CABT4 BH-IB18 BH-CABT2 BH-MU30H3 BH-IB38 BH-CABT0 BH-CABT5 BH-IB28 BH-IB19 BH-IB27 BH-MUHC BH-MU17H2 GIH-MU30H3 GIH-MUHC BH-MUIS BH-IB39 BH-MU17H3 BH-IB16 BH-MU00H5 BH-MU30H4 GIH-LC4 BH-IB36 BH-IB37 GIH-5011 BH-IB26 GIH-5013 GIH-3510 GIH-MUOOH3 GIH-4211 GIH-SAR2 GIH-TB4500 GIH-HCW3 GIH-MU17H3 GIH-LC3 GIH-3710 GIH-MUOOH2 GIH-3713 BH-TB4500N GIH-MU17H2 BH-TB4525 BH-TB4500 GIH-3711 GIH-3708 GIH-4210 GIH-LC2 GIH-4208 GIH-5010 GIH-HCE4 GIH-4213 GIH-MUTB GIH-5008 BR4004 ABA3003 HCW5507 GIH-MU30H4 BH-TB4525N BH-TB4515 GIH-1002 GIH-3508 GIH-3513 SP3710 SP5013 MUA3002 ANS1502 SCA02 SP3713 SP6006 MUA4001 ANS1504 SCA04 BR4005 ABA4001 SAN3809 GIH-1502A RAMUA1703 RSMUA05 LOC06 SA3801 SP3511 ALA1805 SA3809 AN1509 GIH-3511 SP4208 MUS4503 SAW5503 ANS2503 BH-TB4515N GIH-HCW4 RS-SCREW1.6 GIH-SAR3 SP4206 MUS4502 SAW5502 ANS2502 GIH-HCW5 SP3706 ALA1830 MUA1803 AN2511 GIH-TB4500N RS-SCREW1.4 RAMUA3001 RSMUA06 ABA1803 ALA3030 SA3804 BR4001 HCR4507 HCW5504 SCA01 M-MU00H35 RAMUA4501 RTB3801R M-4011 BR4002 HCW5502 HCW5505 RAB1509 GIH-MUSS10 TWHS24 GIH-TB4515 GIH-TB4515N M-MU00H25 RTB3803 SP3508 BR4006 ABA4002 SAN3811 SP4211 MUS4505 HAN3807 SAW5509 AN3509 DF6010 M-MUHC ZO-BALL DF3511 BH-MUSS.MEGA RS-SCREWSH1.4 SP3513 ALA1810 MUA1801 RAB2511 SA3811 AN1511 DF3711 DF5016 RAMUA1701 DF4210 RSMUA02 M-4016 SP3516 ALA1820 MUA1802 SA3813 AN2509 RAMUA3002 RSMUATB M-MU17H4 DF3708 DF5011 DF4208 RSA3802 SP5006 CTB005-R HCR4504 UCLA05-R GIH-4216 RS-SCREWLH1.4 RAMUA4502 RTB3802 SP3708 SP5011 ALA3005 MUA3001 ANS1501 BMC05 DF3716 RAMUA4503 RTB3802R SP3711 SP5016 MUA3003 ANS1503 SCA03 DF3508 SP6010 MUA4003 MUS006 SP4210 MUS4504 HAN3805 SAW5504 ANS2504 RS-SCREW1.4L ABA1802 ALA3020 SA3803 SP3510 ABA4003 SA3807 SAW5512 BH-MUSS.NOB M-MUTB GIH-MUHCSP DF4213 DF3513 RS-SCREW1.6T5 DF3516 M-MU17H3 M-4013 RTB3803R RSA3801 RAB2509 RSMUA01 GIH-3716 RAMUA3003 RTB3801 BH-MUSS.STAR DF5008 DF3710 DF5013 DF3713 DF6008 RS-SCREW1.4LT5W DF6013 CTB015 LOC04 LOCS30 DF4211 RS-SCREW1.4T5 GIH-5016 DF3510 SP6011 LOC01 HAN3803 BSC01 LOC05 SA3815 SP6008 MUA4002 ANS2501 MUH003 RSA3809 RSA3803 RSA3812 EZ-MUTB5.5 SP6013 LOC02 LOCS10 GIH-MUSCSC CTB005 LOC03 LOCS20 BR4003 ABA3002 HCW5503 HCW5506 SP4213 MUS4506 HCR4502 AN4509 RS-SCREW1.72 SP5010 CTB025-R HCR4506 COCR05-R SP3716 ABA3001 MUS4501 SAW5501 LOCM10 ABA1801 ALA3010 SA3802 RS-SCREW1.72T5 RSA3804 SP4216 CTB025 MUTB005DG HCR4503 UCLA05-H M-MU30H3 SP5008 CTB015-R HCR4505 COCR05-H RSA3807 RAMUA1702 RSMUA04 GIH-NEOMUTB DF6011 RSMUA03 RAB1511 RMUAHC M-MU30H4 GIH-HCE2 DF4216 DF4206 TOHS24 DF5006 DF5010 RS-SCREW1.72T5W RS-SCREW1.6T5W RS-SCREWSH1.6 RS-SCREW1.4T5W RS-SCREWSH1.72 RS-SCREW1.4LT5

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device