FDA.reportPublic FDA data

Prosthetic Accessories

Primary DI
27290107272982
Brand
Prosthetic Accessories
Company
A.B. DENTAL DEVICES LTD
Model
P5-3.75,3
Catalog number
P5-3.75,3
Device description
Ball Attachment Abutment
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
K132125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132125000A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEMA.B. Dental Devices , Ltd.2014-01-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290107272985PackageGS110In Commercial Distribution
27290107272982PackageGS1100In Commercial Distribution
07290107272988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010727298517290107272985
2729010727298227290107272982
07290107272988072901072729887290107272988

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
07290107273008Prosthetic AccessoriesP24-bT_NP24-bT_N2026-08-25
07290107273329Prosthetic AccessoriesP25aP25a2026-08-25
07290107273336Prosthetic AccessoriesP25b-10P25b-102026-08-25
07290107277921Prosthetic AccessoriesP4LN-3.75,25P4LN-3.75,252026-08-25
07290107278607Prosthetic AccessoriesP64-3.75,17-4P64-3.75,17-42026-08-25
07290107278614Prosthetic AccessoriesP64-3.75,17-5P64-3.75,17-52026-08-25
07290107278638Prosthetic AccessoriesP64-3.75,30-4P64-3.75,30-42026-08-25
07290107278645Prosthetic AccessoriesP64-3.75,30-5P64-3.75,30-52026-08-25
07290111273292Prosthetic AccessoriesP4C-4,15P4C-4,152026-08-25
07290111273308Prosthetic AccessoriesP4C-4,25P4C-4,252026-08-25
07290111273346Prosthetic AccessoriesP4LC-4,15P4LC-4,152026-08-25
07290111273353Prosthetic AccessoriesP4LC-4,25P4LC-4,252026-08-25
07290111275043Prosthetic AccessoriesP14C-bTP14C-bT2026-08-25
07290111275050Prosthetic AccessoriesP14C-bT-ARP14C-bT-AR2026-08-25
07290111275067Prosthetic AccessoriesP14C-bTs-ARP14C-bTs-AR2026-08-25
07290111275074Prosthetic AccessoriesP14C-bTs-CP14C-bTs-C2026-08-25
07290111275364Prosthetic AccessoriesP55C-4,1P55C-4,12026-08-25
07290111275371Prosthetic AccessoriesP55C-4,2P55C-4,22026-08-25
07290111275388Prosthetic AccessoriesP55C-4,3P55C-4,32026-08-25
07290111275395Prosthetic AccessoriesP55C-4,4P55C-4,42026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532000430Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000447Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000874Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000942Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000959Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002731Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002748Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037115Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037122Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049613Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049620Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049637Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049644Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049651Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049668Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532062841Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532036965Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036972Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036989Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532049576ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532049583ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066047ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066054ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067778ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067785ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532000928ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532000935ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002649ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002656ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002663ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16