FDA.reportPublic FDA data

Prosthetic Accessories

Primary DI
17290111273701
Brand
Prosthetic Accessories
Company
A.B. DENTAL DEVICES LTD
Model
P5-3,20-5set
Catalog number
P5-3,20-5set
Device description
Angular Ball Attachment 20 degree - 5 mm- a+b+c
Published
2019-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290111273701PackageGS110In Commercial Distribution
07290111273704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011127370117290111273701
07290111273704072901112737047290111273704

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure kitA collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+972732454900Info@ab-dent.com

Regulatory Flags#

DUNS number
534128491
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290107270052Titan ImplantsI2-3.75,8I2-3.75,82024-11-19
07290107270106Titan ImplantsI2-4.2,8I2-4.2,82024-11-19
07290107270151Titan ImplantsI2-4.2,18I2-4.2,182024-11-19
07290107270274Titan ImplantsI2-6,8I2-6,82024-11-19
07290107270281Titan ImplantsI2-6,10I2-6,102024-11-19
07290107270298Titan ImplantsI2-6,11.5I2-6,11.52024-11-19
07290107270502Titan ImplantsI5-4.5,6I5-4.5,62024-11-19
07290107270564Titan ImplantsI5-5,6I5-5,62024-11-19
07290107270625Titan ImplantsI5-6,6I5-6,62024-11-19
07290107270793Titan ImplantsI6-2.4,13I6-2.4,132024-11-19
07290107270823Titan ImplantsI6-3,10I6-3,102024-11-19
07290107270830Titan ImplantsI6-3,11.5I6-3,11.52024-11-19
07290107270847Titan ImplantsI6-3,16I6-3,162024-11-19
07290107270854Titan ImplantsI6-3,13I6-3,132024-11-19
07290107270878Titan ImplantsI6-3.2,11.5I6-3.2,11.52024-11-19
07290107270885Titan ImplantsI6-3.2,13I6-3.2,132024-11-19
07290107270908Titan ImplantsI6b-2.4,11.5I6b-2.4,11.52024-11-19
07290107270915Titan ImplantsI6b-2.4,13I6b-2.4,132024-11-19
07290107271189Titan ImplantsI10-4.2,8I10-4.2,82024-11-19
07290107271226Titan ImplantsI10-4.2,16I10-4.2,162024-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840481135989LOCATORZest Anchors, LLCDZE2026-05-22
00840481135996LOCATORZest Anchors, LLCDZE2026-05-22
00840481136009LOCATORZest Anchors, LLCDZE2026-05-22
08806395269907ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269914ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269921ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269938ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269945ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269952ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269969ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269976ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269983ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269990ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270002ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270019ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270026ABBA-ST Strong Co., Ltd.DZE2026-05-22
088000968507858plant Implant System8dent Inc.DZE2026-03-24
088000968507928plant Implant System8dent Inc.DZE2026-03-24
088000968507788plant Implant System8dent Inc.DZE2026-03-23
08800362100002DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100019DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100026DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100033DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100040DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100057DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100064DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100071DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100088DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100095DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20