Manufacturer registered with FDA

Abracadabra Implants Ltd.

Or Yehuda, Israel. Lists 9 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10083470ManufacturerRepacker / relabelerSpecification developer

Device types listed: 9
Brands and models: 256
510(k) clearances: 12021–2021
Markets registered in: 21 registrations outside the US
Establishments: 1Israel

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Abracadabra Implants Ltd. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: IsraelOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Abracadabra Implants Ltd.	1 clearances	2021–2021	Below
Israel	AMAR	Manufacturer	Abracadabra Implants Ltd	1	—	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 Abracadabra Implants 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	BO0833 - Bolero 3.3 mm in diameterBO0837 - Bolero 3.75 mm in diameterBO0842 - Bolero 4.2 mm in diameterBO0850 - Bolero 5 mm in diameterBO0860 - Bolero 6 mm in diameterBO1033 - Bolero 3.3 mm in diameterBO1037 - Bolero 3.75 mm in diameterBO1042 - Bolero 4.2 mm in diameterBO1050 - Bolero 5 mm in diameterBO1060 - Bolero 6 mm in diameter 73 more BO1133 - Bolero 3.3 mm in diameterBO1137 - Bolero 3.75 mm in diameterBO1142 - Bolero 4.2 mm in diameterBO1150 - Bolero 5 mm in diameterBO1160 - Bolero 6 mm in diameterBO1333 - Bolero 3.3 mm in diameterBO1337 - Bolero 3.75 mm in diameterBO1342 - Bolero 4.2 mm in diameterBO1350 - Bolero 5 mm in diameterBO1360 - Bolero 6 mm in diameterBO1633 - Bolero 3.3 mm in diameterBO1637 - Bolero 3.75 mm in diameterBO1642 - Bolero 4.2 mm in diameterSBA 2 - standard ball attachmentSBA 3 - standard ball attachmentSBA 4 - standard ball attachmentSBA 5 - standard ball attachmentSBA 6 - standard ball attachmentSCS 375 - standard cover screwSHC 2 - standard healing cap 4.6 mmSHC 3 - standard healing cap 4.6 mmSHC 4 - standard healing cap 4.6 mmSHC 5 - standard healing cap 4.6 mmSHC 6 - standard healing cap 4.6 mmSHC 7 - standard healing cap 4.6 mmSHCN 3 - standard healing cap narrow 3.8 mmSHCN 4 - standard healing cap narrow 3.8 mmSHCN 5 - standard healing cap narrow 3.8 mmSHCN 6 - standard healing cap narrow 3.8 mmSHCN 7 - standard healing cap narrow 3.8 mmSHCW 2 - standard healing cap wide 5.5 mmSHCW 3 - standard healing cap wide 5.5 mmSHCW 4 - standard healing cap wide 5.5 mmSHCW 5 - standard healing cap wide 5.5 mmSHCW 6 - standard healing cap wide 5.5 mmSHCW 7 - standard healing cap wide 5.5 mmSHCXW 2 - standard healing cap extra wide 5.5 mmSHCXW 3 - standard healing cap extra wide 5.5 mmSHCXW 4 - standard healing cap extra wide 5.5 mmSHCXW 5 - standard healing cap extra wide 5.5 mmSMU 1 - standard multi unitSMU 2 - standard multi unitSMU 3 - standard multi unitSMU 4 - standard multi unitSOD 0.5 - standard overdentureSOD 1.5 - standard overdentureSOD 2.5 - standard overdentureSSA 083 - standard screw for abutmentSSF - fixation screwSSFMU - standard screw for multi unit abutmentSSTWA 11 - smooth straight abutment wideSSTWA 7 - smooth straight abutment wideSSTWA 9 - smooth straight abutment wideSTA 11 - straight abutment 11 mmSTA 7 - straight abutment 7 mmSTA 9 - straight abutment 9 mmSTAA 15-1 - anatomic angular abutment 15 degreesSTAA 15-2 - anatomic angular abutment 15 degreesSTAA 15-3 - anatomic angular abutment 15 degreesSTAA 25-1 - anatomic angular abutment 25 degreesSTAA 25-2 - anatomic angular abutment 25 degreesSTAA 25-3 - anatomic angular abutment 25 degreesSTNA 11 - standard titanium narrow abutment 11 mmSTNA 7 - standard titanium narrow abutment 7 mmSTNA 9 - standard titanium narrow abutment 9 mmSTSA 01 - straight shoulder abutment 4.50mm in diameterSTSA 02 - straight shoulder abutment 4.50mm in diameterSTSA 03 - straight shoulder abutment 4.50mm in diameterSTSA 04 - straight shoulder abutment 4.50mm in diameterSTSWA 1 - straight shoulder wide abutment 5.50mm in diameterSTSWA 2 - straight shoulder wide abutment 5.50mm in diameterSTSWA 3 - straight shoulder wide abutment 5.50mm in diameterSTWA 9 - grooved straight wide abutment 5.5 mm in diameter	2021
Dental Hand InstrumentsDZN · Class 1	Dental hand instruments	Maker	DFOD - Driver For OverdentureDPKOP - Depth Probe Key One PieceHD - Hand DriverHDK 125070 - Hand Driver Key 1.25HDK 125100 - Hand Driver Key 1.25HDK 125150 - Hand Driver Key 1.25HW - Hand Wrench 1/4 HexMM 125220 - Motor MountMM 242220 - Motor MountPAR01 - Parralelomaker upper bridge 13 more PAR02 - Parralelomaker lower bridgePAR03 - Parralelomaker boltPAR04 - Parralelomaker armRDK 125070 - Ratchet Driver Key 1.25RDK 125100 - Ratchet Driver Key 1.25RDK 125150 - Ratchet Driver Key 1.25RDK 242070 - Ratchet Driver Key 2.42RDK 242100 - Ratchet Driver Key 2.42RDK 242150 - Ratchet Driver Key 2.42RDK1610 - Ratchet Driver Key 1.6RDK1620 - Ratchet Driver Key 1.6SR - Standard RatchetSTR - Standard Torq Ratchet	2021
Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1	—	Maker	RP150 - Retentive Post M1.50RP160 - Retentive Post M1.60RP172 - Retentive Post 1-72 UNFRP200 - Retentive Post M20SPP 100 - Standard Parallel PinSPP 160 - Standard Parallel Pin	2021
All Precision AttachmentEGG · Class 1	—	Maker	CN001 Standard Silicon Pink Cap For Ball AttachmentCN002 Standard Silicon Clear Cap For Ball AttachmentCN003 Standard Silicon Yellow Cap For Ball AttachmentINVAHC Attachment Housing CarrierINVMAA Metal Attachment AnchorINVMAH30 Metal Attachment HousingLong Housing for Precision Attachment KeeperPNPFS4 female sleevePNPRR4 retention ring 4mmPNPRRP retention ring post 7 more PNPTP telescopic postPNPTPB telescopic post basePrecision Attachment Keeper LongPrecision Attachment Keeper ShortShort Housing for Precision Attachment KeeperSMC Standard Metal CapSMCFL Standard Metal Cap For Locator	2021
Rubber DamEIE · Class 1	Rubber dam systems	Maker	RRD - Round Rubber Dam	2021
Dental BurEJL · Class 1	Dental burs & diamonds	Maker	HPL39 - Hollow Polishing Bur 3.9mmHPL45 - Hollow Polishing Bur 4.5mmHPL63 - Hollow Polishing Bur 6.3mmHPL75 - Hollow Polishing Bur 7.5mm	2021
Surgical Biopsy PunchEME · Class 1	Dental hand instruments	Maker	TP29 - Tissue Punch 2.9mmTP35 - Tissue Punch 3.5mmTP40 - Tissue Punch 4mmTP50 - Tissue Punch 5mmTPDF - Tissue Punch Driver FemaleTPDM - Tissue Punch Driver Male	2021
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Maker	AM40-Analog 4 mm MetalicAP40-Analog 4 mm PlasticCBM40-Core Buildup MoldCBMB40-Core Buildup Mold baseINVAA-Attachment AnalogINVAT-Attachment TransferINVATB-Attachment Transfer boltMPF22-Metal Post FlexorPFPUT-Plastic For Pop Up TransferPPC20-Plastic Post Carrier 23 more PPF20-Plastic Post FlexorPS20-Plastic SleevePS30-Plastic SleevePS40-Plastic SleeveSACH-Standard Abutment Castable Hex (REDSACN-Standard Abutment Castable Non Hex (WHITE)SAFL-Standard Analog For LOCATORSAFMU-Standard Analog For Multi UnitSAFOD-Standard Analog For OverdentureSIA 375-Standard Implant AnalogSIA 500-Standard Implant AnalogSOT 13.85-Standard Open TransferSSFODA-Standard Screw For Transfer Overdenture AngularSSFT14-Standard Screw For TransferSSFT16-Standard Screw For TransferSSFT22-Standard Screw For TransferSSPFMU-Standard Sleeve Plastic For Multi UnitST 9-Standard TransferST13-Standard TransferSTC 13-Standard Transfer ClipsSTC 9-Standard Transfer ClipsSTFMU-Standard Transfer For Multi UnitSTFOD-Standard Transfer For Overdenture	2021
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Maker	BO0833 - Bolero 3.3 mm in diameterBO0837 - Bolero 3.75 mm in diameterBO0842 - Bolero 4.2 mm in diameterBO0850 - Bolero 5 mm in diameterBO0860 - Bolero 6 mm in diameterBO1033 - Bolero 3.3 mm in diameterBO1037 - Bolero 3.75 mm in diameterBO1042 - Bolero 4.2 mm in diameterBO1050 - Bolero 5 mm in diameterBO1060 - Bolero 6 mm in diameter 73 more BO1133 - Bolero 3.3 mm in diameterBO1137 - Bolero 3.75 mm in diameterBO1142 - Bolero 4.2 mm in diameterBO1150 - Bolero 5 mm in diameterBO1160 - Bolero 6 mm in diameterBO1333 - Bolero 3.3 mm in diameterBO1337 - Bolero 3.75 mm in diameterBO1342 - Bolero 4.2 mm in diameterBO1350 - Bolero 5 mm in diameterBO1360 - Bolero 6 mm in diameterBO1633 - Bolero 3.3 mm in diameterBO1637 - Bolero 3.75 mm in diameterBO1642 - Bolero 4.2 mm in diameterSBA 2 - standard ball attachmentSBA 3 - standard ball attachmentSBA 4 - standard ball attachmentSBA 5 - standard ball attachmentSBA 6 - standard ball attachmentSCS 375 - standard cover screwSHC 2 - standard healing cap 4.6 mmSHC 3 - standard healing cap 4.6 mmSHC 4 - standard healing cap 4.6 mmSHC 5 - standard healing cap 4.6 mmSHC 6 - standard healing cap 4.6 mmSHC 7 - standard healing cap 4.6 mmSHCN 3 - standard healing cap narrow 3.8 mmSHCN 4 - standard healing cap narrow 3.8 mmSHCN 5 - standard healing cap narrow 3.8 mmSHCN 6 - standard healing cap narrow 3.8 mmSHCN 7 - standard healing cap narrow 3.8 mmSHCW 2 - standard healing cap wide 5.5 mmSHCW 3 - standard healing cap wide 5.5 mmSHCW 4 - standard healing cap wide 5.5 mmSHCW 5 - standard healing cap wide 5.5 mmSHCW 6 - standard healing cap wide 5.5 mmSHCW 7 - standard healing cap wide 5.5 mmSHCXW 2 - standard healing cap extra wide 5.5 mmSHCXW 3 - standard healing cap extra wide 5.5 mmSHCXW 4 - standard healing cap extra wide 5.5 mmSHCXW 5 - standard healing cap extra wide 5.5 mmSMU 1 - standard multi unitSMU 2 - standard multi unitSMU 3 - standard multi unitSMU 4 - standard multi unitSOD 0.5 - standard overdentureSOD 1.5 - standard overdentureSOD 2.5 - standard overdentureSSA 083 - standard screw for abutmentSSF - fixation screwSSFMU - standard screw for multi unit abutmentSSTWA 11 - smooth straight abutment wideSSTWA 7 - smooth straight abutment wideSSTWA 9 - smooth straight abutment wideSTA 11 - straight abutment 11 mmSTA 7 - straight abutment 7 mmSTA 9 - straight abutment 9 mmSTAA 15-1 - anatomic angular abutment 15 degreesSTAA 15-2 - anatomic angular abutment 15 degreesSTAA 15-3 - anatomic angular abutment 15 degreesSTAA 25-1 - anatomic angular abutment 25 degreesSTAA 25-2 - anatomic angular abutment 25 degreesSTAA 25-3 - anatomic angular abutment 25 degreesSTNA 11 - standard titanium narrow abutment 11 mmSTNA 7 - standard titanium narrow abutment 7 mmSTNA 9 - standard titanium narrow abutment 9 mmSTSA 01 - straight shoulder abutment 4.50mm in diameterSTSA 02 - straight shoulder abutment 4.50mm in diameterSTSA 03 - straight shoulder abutment 4.50mm in diameterSTSA 04 - straight shoulder abutment 4.50mm in diameterSTSWA 1 - straight shoulder wide abutment 5.50mm in diameterSTSWA 2 - straight shoulder wide abutment 5.50mm in diameterSTSWA 3 - straight shoulder wide abutment 5.50mm in diameterSTWA 9 - grooved straight wide abutment 5.5 mm in diameter	2021

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Abracadabra Implants Ltd. as the applicant.

Decided	510(k)	Device	Device type
23 Sep 2021	K202092	ABC Dental Implant System	DZE Root-Form Endosseous Implant

Registered establishments

Establishment	Location	What it does
ABRACADABRA IMPLANTS LTD.FDA reg. 3021076825	Or Yehuda Central, Israel	Manufacturer, Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10083470). 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.