FDA Registration Active 🇮🇱 Israel

BHI Implants

Reg #: 3010393542 · FEI: 3010393542 · Expires 2026
Products
3
Proprietary Names
638
Establishment Types
2
Classifications
3

Registration Details

Registration Name
BHI Implants
Registration Number
3010393542
FEI Number
3010393542
Status
Active
Expiry Year
2026
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
Accessories, Implant, Dental, Endosseous NDP
Abutment, Implant, Dental, Endosseous NHA
Implant, Endosseous, Root-Form DZE

Proprietary Names

RS-OPD425 RS-OPD550 RS-OPD450 RS-OPD300 RS-OPD500 RS-OPD250 BH-1220 BH-HD2S BH-2100 BH-HD1S BH-MT20 BH-MK2L BH-1120 BH-2000 BH-1MKS BH-DE10 BH-1110 BH-HD1H BH-2200 BH-MK2S BH-TD20 BH-TD37 BH-TD47 BH-HD2L BH-HD1L BH-TD27 BH-TD42 BH-TD32 BH-TD400L16 BH-TD300L16 BH-TD350L16 BH-TD580L16 BH-2010 CD 5x6 CD 3.75x4.20 BH-STT2 BH-SSD1 BH-STT1 GIH-SK01 BH-1MKL BH-TD280L16 BH-TD320L16 BH-TD450L16 TDC330L16 BH-2300 TD320L16 BH-TD520L16 BH-CTTS TD380L16 BH-TD380L16 PD200L16 BH-PD200L16 BH-TD470L16 TD580L16 MDL 1.90 TD500L16 TD300L16 BH-TD420L16 BH-TD370L16 BH-PA01 BH-CTTL BH-PA02 BH-CL10 BH-PKI1 BH-MD20 BH-PCBP BH-HD2H BH-TD480L16 BH-CODR MDI 1.90 BH-TD365L16 BH-112W BH-OTTS BH-CTTLS TDC280L16 TD365L16 TD550L16 TD280L16 BH-OTTL TD420L16 TD520L16 TD410L16 TD400L16 TD350L16 TD480L16 BH-BTCP BH-MUOTTR BH-BARS BH-TBH001 BH-MUANG BH-BARL BH-MUTS BH-IB92 BH-MUTRSC BH-TBG330 BH-MUHLDR BH-IB81 BH-TBZ100 BH-MUPS TDE BH-TBC100 BH-SMUDRVR BH-TBB001 BH-TBD375C BH-TBD330C GIH-MUTS BH-IB91 BH-TBG375 BH-TBD200 GIH-OTTL GIH-CTTL GIH-MUANG GIH-MUOTTR BH-MUTB GIH-MUANG5 BH-MUSP GIH-MUDA GIH-HD1H BH-MUDA GIH-1220 BH-SP4507 GIH-2300 EZ-MUTSSP BH-TBD180 T4213-L GIH-MUPS MUSB005DG BH-IMPDIAN BH-SP4509 GIH-SMUDRVR MUP001 GIH-HD2H MUT004-C A5024 RMUASB07 RSBIMP07 A3824 COCR05-R GIH-IMPDIAN BH-BALLAN T4209-L MUA005DG T4213-S GIH-SP4509 RMUATRF SBODP9 LOCS10 SCA03 SCA02 RMUASB13 LOCS30 RMUASB10-1.6 BMC05 RMUASB13-1.72 IT-BS2x19 LOCM10 RSD242 SBODP7 IT-BS2x13 GIH-RMUDA DAR24 BH-SP.MUANG IT-LP10 MUT004-O RMUASB13-1.6 SCA04 SCA01 RSBIMP09 SCP001 RMUASLV T4209-S BSC01 RDAIMP MUA005 ZO-BALL COCR05-H RMUASB10 PAN105 RS-OPD475 MUT002 PAH105 LOCS20 RMUASB10-1.72 RMUADA RS-OPD525 RS-OPD325 RS-OPD225 RMUASB07-1.72 RS-OPD275 IT-BSSL4 RS-OPDKIT RS-OPD350 RS-OPD375 RMUASB07-1.6 RS-OPD400 BH-1005 BH-1503A BH-D510 BH-AA01 BH-1001 BH-AA04 BH-D410 BH-2512 BH-AA02 BH-1003 BH-SA13 BH-D308 BH-D516 BH-1504A BH-D316 BH-1509C BH-D311 BH-D313 BH-1501A BH-D513 BH-1512 BH-SA06 BH-D310 BH-D411 BH-2509A BH-D511 BH-1509 BH-D508 BH-D611 BH-D616 BH-AA03 BH-1002 BH-1004 BH-1502A BH-D613 BH-D408 BH-2509 BH-D413 BH-D608 BH-D416 BH-D610 BH-SA08 BH-1507 BH-HCS2 BH-C413 BH-1006 BH-PS06 BH-C308 BH-BC00 BH-C310 BH-C616 BH-S311 BH-C410 BH-C416 BH-C613 BH-HCE6 BH-C516 BH-C510 BH-2502A BH-HCE7 BH-PS05 BH-HCE5 BH-C311 BH-C316 BH-SAR4 BH-C411 BH-SH513 BH-S316 BH-C513 BH-SH511 BH-SH408 BH-C611 BH-SA12 BH-2506 BH-C608 BH-HCS7 BH-CS10 BH-S308 BH-SH508 BH-HCE2 BH-C508 BH-C313 BH-2504A BH-SH608 BH-HCW5 BH-HCE3 BH-SH310 BH-SH616 BH-2501A BH-S310 BH-C408 BH-SAS2 BH-HCS6 BH-SAR1 BH-C610 BH-HCW4 BH-SH516 BH-SH610 BH-C511 BH-HCE4 BH-SAS3 BH-HCW3 BH-SH411 BH-S313 BH-HCS4 BH-SAR2 BH-HCS3 BH-HCS5 BH-SH413 BH-SH613 BH-SH410 BH-SH313 BH-SH316 BH-SAT1 BH-SAT2 BH-SH611 BH-SH416 BH-SAS1 BH-SH308 BH-SH311 BH-SAR3 BH-2503A BH-SH510 BH-AABT1 BH-AABT5 BH-BTBT2 BH-CABT6 BH-CABT2 BH-AABT2 BH-CABT4 BH-CABT1 BH-AABT3 BH-BTBT3 BH-AABT0 BH-AABT6 BH-BTBT6 BH-BTBT4 BH-IB26 BH-MUIS BH-CABT5 BH-IB39 BH-AABT4 BH-BTBT1 BH-MU17H3 BH-MU30H4 BH-BABT0 BH-CABT0 BH-BTBT5 BH-CABT3 BH-IB36 BH-MUSS BH-MU00H3 BH-MU00H5 GIH-MUOOH2 GIH-5011 BH-MU00H4 BH-IB19 BH-IB29 BH-MU30H3 BH-IB37 BH-IB27 BH-MU00H2 BH-MU17H2 BH-MUHC BH-IB16 GIH-MU30H3 GIH-4208 GIH-LC2 BH-IB17 GIH-3711 BH-IB38 BH-IB18 GIH-MU30H4 GIH-4211 BH-IB28 GIH-HCW3 GIH-4210 BH-TB4525N GIH-MUOOH3 GIH-3511 GIH-LC3 GIH-3710 GIH-5013 GIH-MU17H2 GIH-3713 GIH-MUHC GIH-HCE4 GIH-4213 GIH-MU17H3 GIH-HCW4 GIH-SAR2 GIH-5010 GIH-MUTB GIH-5008 GIH-LC4 GIH-3708 GIH-TB4500N SP4211 CTB005 LOC03 SAN3811 SAW5509 MUA1802 AN4509 GIH-3510 GIH-SAR3 GIH-1002 GIH-HCW5 SP3511 HCR4503 SA3809 RTB3802R SP6010 ABA4002 MUS4505 SAW5502 ANS2502 GIH-3508 SP5016 ABA3002 SA3803 ANS1503 GIH-MUSS10 SP3706 SP5010 ABA1802 HCR4506 SA3815 GIH-1502A BH-TB4515 CTB015-R ABA1801 ALA3010 AN2509 SP5013 ABA3001 SA3802 GIH-TB4500 M-MU30H4 GIH-3513 BR4001 ALA3030 ANS1501 GIH-TB4515 M-MU17H4 RAB2509 M-4011 BH-TB4500N EZ-MUTB5.5 RS-SCREW1.4 BH-TB4500 SP3711 MUA3003 HCW5503 BH-TB4525 RSMUA02 BH-TB4515N DF4210 RSMUA04 RAMUA1702 ALA1810 MUA1801 AN3509 RAMUA3001 GIH-TB4515N SP6008 ABA4001 SAW5501 ANS2501 MUA3001 HCR4507 UCLA05-R BH-MUSS.NOB RSMUA05 DF3508 DF3716 DF6010 TWHS24 DF3513 M-MU30H3 DF3710 DF5013 RAB1511 RMUAHC DF5006 DF3708 SP3516 SP5008 HCR4505 SA3813 RS-SCREW1.6 DF5010 SP3716 BR4005 HCW5505 GIH-NEOMUTB RS-SCREW1.72 RSMUA01 SP3713 BR4004 MUA4001 HCW5504 SP4213 CTB015 LOC04 ALA1820 SA3807 SAW5512 RS-SCREWSH1.4 RSA3802 RSMUATB DF3713 DF6008 TOHS24 SP4216 CTB025 LOC05 ALA1830 AN1509 SP4206 BR4006 HCW5506 CTB005-R LOC06 ALA3005 AN1511 M-MUHC RS-SCREW1.4T5W BH-MUSS.STAR RSA3801 RSMUA06 RTB3803 DF3511 SP6006 ABA3003 SA3804 ANS1504 GIH-MUSCSC RTB3803R RSA3803 RTB3801 RAMUA1701 RS-SCREWSH1.72 DF4211 DF4213 SP3708 SP5011 ABA1803 SA3801 BH-MUSS.MEGA DF4216 RS-SCREW1.72T5W BR4002 MUS4501 MUA4002 ANS1502 DF3711 DF5016 RSMUA03 RS-SCREW1.6T5W SP3513 SP5006 HCR4504 SA3811 SP4208 LOC01 HCW5507 SAW5503 RAMUA3002 SP4210 SP6013 LOC02 SAN3809 SAW5504 DF3516 SP3710 MUA3002 HCW5502 RTB3801R SP3510 HCR4502 DF5011 M-4016 RTB3802 MUS4504 HAN3805 MUH003 GIH-MUHCSP M-MU17H3 MUA1803 UCLA05-H DF4206 DF3510 RSA3812 GIH-3716 M-MU00H25 BR4003 MUS4502 MUA4003 MUS4503 HAN3803 DF4208 M-MUTB RAMUA4502 RSA3807 GIH-HCE2 RAB2511 ALA1805 MUTB005DG ANS2504 RAMUA4501 RSA3804 RAMUA3003 CTB025-R ALA3020 AN2511 SP3508 HAN3807 MUS006 SP6011 ABA4003 MUS4506 ANS2503 RAB1509 GIH-4216 RS-SCREW1.6T5 RS-SCREW1.4L M-MU00H35 RAMUA1703 M-4013 RAMUA4503 RSA3809 RS-SCREWSH1.6 DF6013 DF5008 DF6011 RS-SCREW1.4T5 GIH-5016 RS-SCREW1.4LT5 RS-SCREW1.72T5 RS-SCREWLH1.4 BH-NMUSS RS-SCREW1.4LT5W

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device