FDA.reportPublic FDA data

Prosthetic Accessories

Primary DI
27290107273408
Brand
Prosthetic Accessories
Company
A.B. DENTAL DEVICES LTD
Model
P7a-2
Catalog number
P7a-2
Device description
Screw
Published
2020-01-22
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112440000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112440000AB DENTAL DEVICES IMPLANTS AND ACCESSORIESA.B. Dental Devices , Ltd.2012-04-18DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290107273401PackageGS110In Commercial Distribution
27290107273408PackageGS1100In Commercial Distribution
07290107273404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010727340117290107273401
2729010727340827290107273408
07290107273404072901072734047290107273404

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.

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
00810126046871ET III Fixture SA Regular No MountHIOSSEN, INC.DZE2026-07-14
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26