FDA.reportPublic FDA data

UniFit Angled Abutment 15° 1mm

Primary DI
07290109303925
Brand
UniFit Angled Abutment 15° 1mm
Company
ADIN DENTAL IMPLANT SYSTEMS LTD
Model
UF0013
Published
2024-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

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
K223714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223714000UniFit Dental Implant SystemAdin Dental Implant Systems , Ltd.2023-12-29DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109303925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109303925072901093039257290109303925

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

Regulatory Flags#

DUNS number
533289435
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109308609Single TMA Plastic Casting Sleeve w/Prosthetic ScrewRS5001S2026-05-11
07290109308616Single TMA ReplicaRS5004S2026-05-11
07290109308647Single TMA Closed Tray TransferRS5011S2026-05-11
07290109308630Single TMA Open Tray TransferRS5006S2025-12-15
07290116778662Zygomatic Surgical Kit, Standard Hex ZGSK0012026-04-19
07290105150004Touareg CloseFit™ Plastic Surgical Kit-PremiumCF63002017-04-23
07290105150028Touareg CloseFit™ Plastic Surgical Kit-AdvancedCF63022017-04-23
07290105150035Touareg CloseFit™ Plastic Surgical Kit-StarterCF63032017-04-23
07290105150042Touareg CloseFit™ Plastic Surgical Kit-Advanced Short DrillsCF63042017-04-23
07290105150059Touareg CloseFit™ Plastic Surgical Kit-Starter Short DrillsCF63052017-04-23
07290105155429RS Angled Trans Mucosal Abutment 45° 4mmRS37362026-03-26
07290109309293Touareg™ OS Zygomatic Dental Implant 4.2D 35LISZT35422026-03-26
07290109309309Touareg™ OS Zygomatic Dental Implant 4.2D 37.5LISZT37422026-03-26
07290109309316Touareg™ OS Zygomatic Dental Implant 4.2D 40LISZT40422026-03-26
07290109309323Touareg™ OS Zygomatic Dental Implant 4.2D 42.5LISZT42422026-03-26
07290109309330Touareg™ OS Zygomatic Dental Implant 4.2D 45LISZT45422026-03-26
07290109309347Touareg™ OS Zygomatic Dental Implant 4.2D 47.5LISZT47422026-03-26
07290109309354Touareg™ OS Zygomatic Dental Implant 4.2D 50LISZT50422026-03-26
07290109309361Touareg™ OS Zygomatic Dental Implant 4.2D 52.5LISZT52422026-03-26
07290109309378Touareg™ OS Zygomatic Dental Implant 4.2D 55LISZT55422026-03-26

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