Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021076825

FEI Number

3021076825

Entity Name

ABRACADABRA IMPLANTS LTD.

City/State/Country

Or Yehuda Central, IL

Establishment Address

Haharoshet 12, Or Yehuda Central 6037580, IL

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Abracadabra Implants Ltd. (Owner Number: 10083470)

Owner / Operator Contact Address

Haharoshet 12, Or Yehuda, IL-M 6037580, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CN003 Standard Silicon Yellow Cap For Ball Attachment INVAHC Attachment Housing Carrier PNPRRP retention ring post SMCFL Standard Metal Cap For Locator PNPTP telescopic post PNPFS4 female sleeve INVMAH30 Metal Attachment Housing CN002 Standard Silicon Clear Cap For Ball Attachment PNPRR4 retention ring 4mm SMC Standard Metal Cap PNPTPB telescopic post base CN001 Standard Silicon Pink Cap For Ball Attachment INVMAA Metal Attachment Anchor Short Housing for Precision Attachment Keeper Precision Attachment Keeper Short Precision Attachment Keeper Long Long Housing for Precision Attachment Keeper RP160 - Retentive Post M1.60 RP172 - Retentive Post 1-72 UNF SPP 160 - Standard Parallel Pin SPP 100 - Standard Parallel Pin RP200 - Retentive Post M20 RP150 - Retentive Post M1.50 STAA 25-2 - anatomic angular abutment 25 degrees BO1337 - Bolero 3.75 mm in diameter SHCXW 3 - standard healing cap extra wide 5.5 mm BO0833 - Bolero 3.3 mm in diameter STAA 15-3 - anatomic angular abutment 15 degrees SHCW 2 - standard healing cap wide 5.5 mm SMU 4 - standard multi unit BO1160 - Bolero 6 mm in diameter STSA 01 - straight shoulder abutment 4.50mm in diameter BO1142 - Bolero 4.2 mm in diameter SHCXW 4 - standard healing cap extra wide 5.5 mm STSWA 1 - straight shoulder wide abutment 5.50mm in diameter BO1360 - Bolero 6 mm in diameter SBA 5 - standard ball attachment STSA 04 - straight shoulder abutment 4.50mm in diameter BO1642 - Bolero 4.2 mm in diameter SHCN 5 - standard healing cap narrow 3.8 mm SOD 2.5 - standard overdenture SCS 375 - standard cover screw STSWA 2 - straight shoulder wide abutment 5.50mm in diameter SHC 5 - standard healing cap 4.6 mm BO1137 - Bolero 3.75 mm in diameter SBA 4 - standard ball attachment BO1133 - Bolero 3.3 mm in diameter BO1150 - Bolero 5 mm in diameter BO0860 - Bolero 6 mm in diameter SHCXW 2 - standard healing cap extra wide 5.5 mm SHC 3 - standard healing cap 4.6 mm SHCW 6 - standard healing cap wide 5.5 mm STA 9 - straight abutment 9 mm BO0842 - Bolero 4.2 mm in diameter BO1333 - Bolero 3.3 mm in diameter BO1042 - Bolero 4.2 mm in diameter SMU 2 - standard multi unit BO1037 - Bolero 3.75 mm in diameter SHCW 7 - standard healing cap wide 5.5 mm BO1050 - Bolero 5 mm in diameter STSA 03 - straight shoulder abutment 4.50mm in diameter SHCW 5 - standard healing cap wide 5.5 mm SBA 6 - standard ball attachment SSTWA 7 - smooth straight abutment wide BO1033 - Bolero 3.3 mm in diameter STSA 02 - straight shoulder abutment 4.50mm in diameter SOD 0.5 - standard overdenture STAA 15-1 - anatomic angular abutment 15 degrees SHCXW 5 - standard healing cap extra wide 5.5 mm SSTWA 9 - smooth straight abutment wide SHC 7 - standard healing cap 4.6 mm SSF - fixation screw BO1060 - Bolero 6 mm in diameter SMU 3 - standard multi unit SHCW 4 - standard healing cap wide 5.5 mm SHCN 6 - standard healing cap narrow 3.8 mm BO1637 - Bolero 3.75 mm in diameter SHCW 3 - standard healing cap wide 5.5 mm STWA 9 - grooved straight wide abutment 5.5 mm in diameter BO1350 - Bolero 5 mm in diameter SSA 083 - standard screw for abutment SHC 6 - standard healing cap 4.6 mm SHC 4 - standard healing cap 4.6 mm STSWA 3 - straight shoulder wide abutment 5.50mm in diameter BO1633 - Bolero 3.3 mm in diameter SBA 3 - standard ball attachment STNA 9 - standard titanium narrow abutment 9 mm BO0837 - Bolero 3.75 mm in diameter BO1342 - Bolero 4.2 mm in diameter SHCN 4 - standard healing cap narrow 3.8 mm SMU 1 - standard multi unit SBA 2 - standard ball attachment SOD 1.5 - standard overdenture STNA 7 - standard titanium narrow abutment 7 mm SHCN 7 - standard healing cap narrow 3.8 mm SSTWA 11 - smooth straight abutment wide STAA 25-1 - anatomic angular abutment 25 degrees STAA 25-3 - anatomic angular abutment 25 degrees BO0850 - Bolero 5 mm in diameter STNA 11 - standard titanium narrow abutment 11 mm STA 7 - straight abutment 7 mm SHCN 3 - standard healing cap narrow 3.8 mm STAA 15-2 - anatomic angular abutment 15 degrees SSFMU - standard screw for multi unit abutment STA 11 - straight abutment 11 mm SHC 2 - standard healing cap 4.6 mm TPDM - Tissue Punch Driver Male TP29 - Tissue Punch 2.9mm TP40 - Tissue Punch 4mm TP35 - Tissue Punch 3.5mm TP50 - Tissue Punch 5mm TPDF - Tissue Punch Driver Female

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2021-11-28
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	Class 1	872.3740	2021-11-28
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-23
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	2021-11-28

Official Correspondent

Daniel Younisian

US Agent Details

Jeremy Medioni Email: marcel@abcimp.com Phone: (408) 4442471

Related Public Records

Same Entity

Abracadabra Implants Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

Similar Registrations

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3004730002	D B ORTHODONTICS LTD	WEST YORKSHIRE England, GB
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3004203816	MIS Implants Technologies Ltd.	BAR LEV INDUSTRIAL PARK Northern, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021076825. Last updated year: 2026. Please use registration number 3021076825 when referencing this establishment in official correspondence.