FDA.reportPublic FDA data

Prosthetic Accessories

Primary DI
07290111277719
Brand
Prosthetic Accessories
Company
A.B. DENTAL DEVICES LTD
Model
P3TC-4,1.5
Catalog number
P3TC-4,1.5
Device description
Temporary Ti Base ø4.6 GH1.5mm for Crown Conical Platform
Published
2026-08-25
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250806000Dental Implant SystemA.B. Dental Devices , Ltd.2026-06-18DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290111277719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290111277719072901112777197290111277719

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

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
088000968494378plant Implant System8dent Inc.NHA2026-10-16
088000968494758plant Implant System8dent Inc.NHA2026-10-16
088000968496428plant Implant System8dent Inc.NHA2026-10-16
088000968496738plant Implant System8dent Inc.NHA2026-10-16
088000968499498plant Implant System8dent Inc.NHA2026-10-16
088000968499638plant Implant System8dent Inc.NHA2026-10-16
088000968501438plant Implant System8dent Inc.NHA2026-10-16
088000968501508plant Implant System8dent Inc.NHA2026-10-16
088000968501678plant Implant System8dent Inc.NHA2026-10-16
088000968501818plant Implant System8dent Inc.NHA2026-10-16
088000968501988plant Implant System8dent Inc.NHA2026-10-16
088000968513248plant Implant System8dent Inc.NHA2026-10-16
088000968513318plant Implant System8dent Inc.NHA2026-10-16
088000968513488plant Implant System8dent Inc.NHA2026-10-16
088000968513558plant Implant System8dent Inc.NHA2026-10-16
088000968513628plant Implant System8dent Inc.NHA2026-10-16
088000968513798plant Implant System8dent Inc.NHA2026-10-16
088000968513868plant Implant System8dent Inc.NHA2026-10-16
088000968513938plant Implant System8dent Inc.NHA2026-10-16
088000968514308plant Implant System8dent Inc.NHA2026-10-16
088000968514478plant Implant System8dent Inc.NHA2026-10-16
088000968514548plant Implant System8dent Inc.NHA2026-10-16
088000968515088plant Implant System8dent Inc.NHA2026-10-16
088000968515918plant Implant System8dent Inc.NHA2026-10-16
088000968516458plant Implant System8dent Inc.NHA2026-10-16
088000968516528plant Implant System8dent Inc.NHA2026-10-16
088000968516698plant Implant System8dent Inc.NHA2026-10-16
088000968581328plant Implant System8dent Inc.NHA2026-10-16
088000968586518plant Implant System8dent Inc.NHA2026-10-16
088000968586688plant Implant System8dent Inc.NHA2026-10-16