FDA.reportPublic FDA data

(INOSS System) Abutment Screw

Primary DI
00810112922653
Brand
(INOSS System) Abutment Screw
Company
Inosys, Inc.
Model
IBAS-00
Device description
Abutment screw is used to connect with Fixture.
Published
2026-08-27
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
00810112922653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112922653008101129226538101129226530810112922653

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
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
00810112922448(INOSS System) Healing AbutmentIBHA-07072026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112922530(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922547(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922554(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922561(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922578(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922585(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922592(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922608(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922615(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922622(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922639(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922646(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
08059224217932OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217949OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217956OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217963OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217970OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217987OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217994OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218021OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218045OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218052OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218069OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218076OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218083OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218090OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218106OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218113OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218120OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218137OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27