FDA Registration
Active
🇮🇱 Israel
ABRACADABRA IMPLANTS LTD.
Reg #: 3021076825
·
FEI: 3021076825
·
Expires 2026
Products
9
Proprietary Names
173
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- ABRACADABRA IMPLANTS LTD.
- Registration Number
- 3021076825
- FEI Number
- 3021076825
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Haharoshet 12
- City
- Or Yehuda Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K202092
Owner / Operator
- Firm Name
- Abracadabra Implants Ltd.
- Operator Number
- 10083470
- Address
- Haharoshet 12
- City
- Or Yehuda
- State
- Central
- Postal Code
- 6037580
- Country
- IL
- Correspondent
- Daniel Younisian
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2021-11-28 |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | Class 1 | Dental | No | 2021-11-28 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2021-11-23 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2021-11-23 |
| Punch, Biopsy, Surgical | EME | Class 1 | Dental | No | 2021-11-28 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2021-11-28 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2021-11-28 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2021-11-28 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2021-11-28 |
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
HPL75 - Hollow Polishing Bur 7.5mm
HPL63 - Hollow Polishing Bur 6.3mm
HPL45 - Hollow Polishing Bur 4.5mm
HPL39 - Hollow Polishing Bur 3.9mm
MM 242220 - Motor Mount
RDK1610 - Ratchet Driver Key 1.6
PAR03 - Parralelomaker bolt
MM 125220 - Motor Mount
HDK 125150 - Hand Driver Key 1.25
RDK 242150 - Ratchet Driver Key 2.42
PAR01 - Parralelomaker upper bridge
DFOD - Driver For Overdenture
RDK 125150 - Ratchet Driver Key 1.25
HD - Hand Driver
RDK1620 - Ratchet Driver Key 1.6
RDK 125100 - Ratchet Driver Key 1.25
HDK 125070 - Hand Driver Key 1.25
RDK 125070 - Ratchet Driver Key 1.25
RDK 242100 - Ratchet Driver Key 2.42
HDK 125100 - Hand Driver Key 1.25
PAR02 - Parralelomaker lower bridge
STR - Standard Torq Ratchet
PAR04 - Parralelomaker arm
SR - Standard Ratchet
HW - Hand Wrench 1/4 Hex
DPKOP - Depth Probe Key One Piece
RDK 242070 - Ratchet Driver Key 2.42
SAFOD-Standard Analog For Overdenture
MPF22-Metal Post Flexor
SAFL-Standard Analog For LOCATOR
PS30-Plastic Sleeve
PS20-Plastic Sleeve
SACN-Standard Abutment Castable Non Hex (WHITE)
CBMB40-Core Buildup Mold base
AM40-Analog 4 mm Metalic
PPF20-Plastic Post Flexor
ST13-Standard Transfer
AP40-Analog 4 mm Plastic
STC 13-Standard Transfer Clips
SIA 375-Standard Implant Analog
ST 9-Standard Transfer
SSFODA-Standard Screw For Transfer Overdenture Angular
PFPUT-Plastic For Pop Up Transfer
SACH-Standard Abutment Castable Hex (RED
SOT 13.85-Standard Open Transfer
CBM40-Core Buildup Mold
SSFT16-Standard Screw For Transfer
PS40-Plastic Sleeve
PPC20-Plastic Post Carrier
INVAT-Attachment Transfer
STC 9-Standard Transfer Clips
INVATB-Attachment Transfer bolt
STFOD-Standard Transfer For Overdenture
SSPFMU-Standard Sleeve Plastic For Multi Unit
SSFT22-Standard Screw For Transfer
SIA 500-Standard Implant Analog
SSFT14-Standard Screw For Transfer
SAFMU-Standard Analog For Multi Unit
STFMU-Standard Transfer For Multi Unit
INVAA-Attachment Analog
RRD - Round Rubber Dam
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device