FDA.reportPublic FDA data

(INOSS System) Stock Abutment

Primary DI
00810112922462
Brand
(INOSS System) Stock Abutment
Company
Inosys, Inc.
Model
IBSA-354520
Device description
Stock Abutment is a two-piece abutment that is first secured to the dental implant with an abutment screw. The dental prosthesis is then connected to the abutment with dental cement. This is being used for making a final artificial tooth to provide masticatory and aesthetic functions. Stock Abutment is supplied as non-sterile.
Published
2026-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
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
K260006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260006000INOSS SystemInosys, Inc.2026-06-17DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112922462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112922462008101129224628101129224620810112922462

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
101803383
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
00810112922530(INOSS System) Stock AbutmentIBSA-4555402026-08-27
00810112922547(INOSS System) Stock AbutmentIBSA-4555502026-08-27
00810112922554(INOSS System) Stock AbutmentIBSA-4565102026-08-27
00810112922561(INOSS System) Stock AbutmentIBSA-4565202026-08-27
00810112922578(INOSS System) Stock AbutmentIBSA-4565302026-08-27
00810112922585(INOSS System) Stock AbutmentIBSA-4565402026-08-27
00810112922592(INOSS System) Stock AbutmentIBSA-4565502026-08-27
00810112922608(INOSS System) Stock AbutmentIBSA-5765102026-08-27
00810112922615(INOSS System) Stock AbutmentIBSA-5765202026-08-27
00810112922622(INOSS System) Stock AbutmentIBSA-5765302026-08-27
00810112922639(INOSS System) Stock AbutmentIBSA-5765402026-08-27
00810112922646(INOSS System) Stock AbutmentIBSA-5765502026-08-27
00810112922653(INOSS System) Abutment ScrewIBAS-002026-08-27
00810112922370(INOSS System) Healing AbutmentIBHA-06052026-08-26
00810112922387(INOSS System) Healing AbutmentIBHA-06062026-08-26
00810112922394(INOSS System) Healing AbutmentIBHA-06072026-08-26
00810112922400(INOSS System) Healing AbutmentIBHA-07032026-08-26
00810112922417(INOSS System) Healing AbutmentIBHA-07042026-08-26
00810112922424(INOSS System) Healing AbutmentIBHA-07052026-08-26
00810112922431(INOSS System) Healing AbutmentIBHA-07062026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899878068181NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068198NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068211NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068228NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068235NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068242NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068259NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07392532151156Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
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07392532216411ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216428ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216435ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216442ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216459ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216466ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18