Manufacturer registered with FDA
BHI Implant l Ltd.
Afula, Israel. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 1,138
- 510(k) clearances
- 0as applicant
- Markets registered in
- 310 registrations outside the US
- Establishments
- 1Israel
Registered in 3 markets
Where regulators' registries name BHI Implant l Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: IsraelOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | BHI Implant l Ltd. | 3 device types | — | Below |
| Colombia | INVIMA | Registration holder | BHI IMPLANTS LTD | 6 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | BHI IMPLANTS LTD.BHI Implants Ltd. | 4 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What BHI Implant l Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | ABA1801ABA1802ABA1803ABA3001ABA3002ABA3003ABA4001ABA4002ABA4003ALA1805 446 moreALA1810ALA1820ALA1830ALA3005ALA3010ALA3020ALA3030AN1509AN1511AN2509AN2511AN3509AN4509ANS1501ANS1502ANS1503ANS1504ANS2501ANS2502ANS2503ANS2504BH-1001BH-1002BH-1003BH-1004BH-1005BH-1006BH-1501ABH-1502ABH-1503ABH-1504ABH-1507BH-1509BH-1509CBH-1512BH-2501ABH-2502ABH-2503ABH-2504ABH-2506BH-2509BH-2509ABH-2512BH-AA01BH-AA02BH-AA03BH-AA04BH-AABT0BH-AABT1BH-AABT2BH-AABT3BH-AABT4BH-AABT5BH-AABT6BH-BABT0BH-BC00BH-BTBT1BH-BTBT2BH-BTBT3BH-BTBT4BH-BTBT5BH-BTBT6BH-C308BH-C310BH-C311BH-C313BH-C316BH-C408BH-C410BH-C411BH-C413BH-C416BH-C508BH-C510BH-C511BH-C513BH-C516BH-C608BH-C610BH-C611BH-C613BH-C616BH-CABT0BH-CABT1BH-CABT2BH-CABT3BH-CABT4BH-CABT5BH-CABT6BH-CS10BH-D308BH-D310BH-D311BH-D313BH-D316BH-D408BH-D410BH-D411BH-D413BH-D416BH-D508BH-D510BH-D511BH-D513BH-D516BH-D608BH-D610BH-D611BH-D613BH-D616BH-HCE2BH-HCE3BH-HCE4BH-HCE5BH-HCE6BH-HCE7BH-HCS2BH-HCS3BH-HCS4BH-HCS5BH-HCS6BH-HCS7BH-HCW3BH-HCW4BH-HCW5BH-IB16BH-IB17BH-IB18BH-IB19BH-IB26BH-IB27BH-IB28BH-IB29BH-IB36BH-IB37BH-IB38BH-IB39BH-MU00H2BH-MU00H3BH-MU00H4 | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | A3824A5024ABO-ApolloABO-BixbyABO-ChaumontABO-DragonABO-HellgateABO-RialtoABO-ScanAnalogABO-Scanninginsert 216 moreABO-ToolBH-1110BH-1120BH-112WBH-1220BH-1MKLBH-1MKSBH-2000BH-2010BH-2100BH-2200BH-2300BH-BALLANBH-BARLBH-BARSBH-BTCPBH-CL10BH-CODRBH-CTTLBH-CTTLSBH-CTTSBH-DE10BH-HD1HBH-HD1LBH-HD1SBH-HD2HBH-HD2LBH-HD2SBH-IB81BH-IB91BH-IB92BH-IMPDIANBH-MD20BH-MK2LBH-MK2SBH-MT20BH-MUANGBH-MUDABH-MUHLDRBH-MUOTTRBH-MUPSBH-MUSPBH-MUTBBH-MUTRSCBH-MUTSBH-OTTLBH-OTTSBH-PA01BH-PA02BH-PCBPBH-PD200L16BH-PKI1BH-SMUDRVRBH-SP.MUANGBH-SP4507BH-SP4509BH-SSD1BH-STT1BH-STT2BH-TBB001BH-TBC100BH-TBD180BH-TBD200BH-TBD330CBH-TBD375CBH-TBG330BH-TBG375BH-TBH001BH-TBZ100BH-TD20BH-TD27BH-TD280L16BH-TD300L16BH-TD32BH-TD320L16BH-TD350L16BH-TD365L16BH-TD37BH-TD370L16BH-TD380L16BH-TD400L16BH-TD42BH-TD420L16BH-TD450L16BH-TD47BH-TD470L16BH-TD480L16BH-TD520L16BH-TD580L16BMC05BSC01CD 3.75x4.20CD 5x6COCR05-HCOCR05-RCR29CR35CR45DAR24EZ-MUTSSPGIH-1220GIH-2300GIH-CTTLGIH-HD1HGIH-HD2HGIH-IMPDIANGIH-MUANGGIH-MUANG5GIH-MUDAGIH-MUOTTRGIH-MUPSGIH-MUTSGIH-OTTLGIH-RMUDAGIH-SK01GIH-SMUDRVRGIH-SP4509IT-BS2x13IT-BS2x19IT-BSSL4IT-LP10LOCM10LOCS10LOCS20LOCS30MDI 1.90MDL 1.90MUA005MUA005DGMUP001MUSB005DGMUT002MUT004-CMUT004-OPAH105PAN105PD200L16RDAIMPRMUADARMUASB07 | 2013 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | ABA1801ABA1802ABA1803ABA3001ABA3002ABA3003ABA4001ABA4002ABA4003ALA1805 446 moreALA1810ALA1820ALA1830ALA3005ALA3010ALA3020ALA3030AN1509AN1511AN2509AN2511AN3509AN4509ANS1501ANS1502ANS1503ANS1504ANS2501ANS2502ANS2503ANS2504BH-1001BH-1002BH-1003BH-1004BH-1005BH-1006BH-1501ABH-1502ABH-1503ABH-1504ABH-1507BH-1509BH-1509CBH-1512BH-2501ABH-2502ABH-2503ABH-2504ABH-2506BH-2509BH-2509ABH-2512BH-AA01BH-AA02BH-AA03BH-AA04BH-AABT0BH-AABT1BH-AABT2BH-AABT3BH-AABT4BH-AABT5BH-AABT6BH-BABT0BH-BC00BH-BTBT1BH-BTBT2BH-BTBT3BH-BTBT4BH-BTBT5BH-BTBT6BH-C308BH-C310BH-C311BH-C313BH-C316BH-C408BH-C410BH-C411BH-C413BH-C416BH-C508BH-C510BH-C511BH-C513BH-C516BH-C608BH-C610BH-C611BH-C613BH-C616BH-CABT0BH-CABT1BH-CABT2BH-CABT3BH-CABT4BH-CABT5BH-CABT6BH-CS10BH-D308BH-D310BH-D311BH-D313BH-D316BH-D408BH-D410BH-D411BH-D413BH-D416BH-D508BH-D510BH-D511BH-D513BH-D516BH-D608BH-D610BH-D611BH-D613BH-D616BH-HCE2BH-HCE3BH-HCE4BH-HCE5BH-HCE6BH-HCE7BH-HCS2BH-HCS3BH-HCS4BH-HCS5BH-HCS6BH-HCS7BH-HCW3BH-HCW4BH-HCW5BH-IB16BH-IB17BH-IB18BH-IB19BH-IB26BH-IB27BH-IB28BH-IB29BH-IB36BH-IB37BH-IB38BH-IB39BH-MU00H2BH-MU00H3BH-MU00H4 | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
BHI Implant l Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Bhdental, Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Feb 2011 | K103280 | BHDENTAL IMPLANT SYSTEM | Bhdental, Ltd. | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BHI ImplantsFDA reg. 3010393542 | Afula Northern, Israel | Manufacturer, Repacker / relabeler |
Other names on FDA records
BHI Implants Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10044723). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.