FDA.reportPublic FDA data

(INOSS System) Healing Abutment

Primary DI
00810112922424
Brand
(INOSS System) Healing Abutment
Company
Inosys, Inc.
Model
IBHA-0705
Device description
Healing Abutment is used with the fixture to protect the inner configuration of the implant and to maintain, stabilize and form the soft tissue during the healing process.
Published
2026-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
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
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
00810112922424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112922424008101129224248101129224240810112922424

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
088000968494138plant Implant System8dent Inc.NHA2026-10-15
088000968498028plant Implant System8dent Inc.NHA2026-10-15
088000968501748plant Implant System8dent Inc.NHA2026-10-15
088000968515228plant Implant System8dent Inc.NHA2026-10-15
088000968515398plant Implant System8dent Inc.NHA2026-10-15
088000968515538plant Implant System8dent Inc.NHA2026-10-15
088000968516078plant Implant System8dent Inc.NHA2026-10-15
088000968516148plant Implant System8dent Inc.NHA2026-10-15
088000968516218plant Implant System8dent Inc.NHA2026-10-15
088000968516388plant Implant System8dent Inc.NHA2026-10-15
088000968588358plant Implant System8dent Inc.NHA2026-10-15
088000968600678plant Implant System8dent Inc.NHA2026-10-15
088000968603028plant Implant System8dent Inc.NHA2026-10-15
088000968609068plant Implant System8dent Inc.NHA2026-10-15
088000968616758plant Implant System8dent Inc.NHA2026-10-15
088000968620618plant Implant System8dent Inc.NHA2026-10-15
088000968621848plant Implant System8dent Inc.NHA2026-10-15
088000968623378plant Implant System8dent Inc.NHA2026-10-15
088000968688728plant Implant System8dent Inc.NHA2026-10-15
07290114710756prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710787prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710800prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710831prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710848prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114711654prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114711661prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712026prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712170prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712651prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712668prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14