FDA.reportPublic FDA data

RS Angled Trans Mucosal Abutment 45° 4mm

Primary DI
07290105155429
Brand
RS Angled Trans Mucosal Abutment 45° 4mm
Company
ADIN DENTAL IMPLANT SYSTEMS LTD
Model
RS3736
Published
2026-03-26
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
K252031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252031000Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.2026-03-23DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290105155429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290105155429072901051554297290105155429

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
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
07290109309385Zygomatic pilot Drill 1.8/2.5mmD x 35-55mmLDL55252026-03-26

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