FDA.reportPublic FDA data

Multiunit Abutment Temporary Cylinder

Primary DI
08800039379366
Brand
Multiunit Abutment Temporary Cylinder
Company
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Model
MCTH48R
Published
2021-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K202479000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202479000IBS Implant SystemInnobiosurg Co., Ltd.2020-09-23DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800039379366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039379366088000393793668800039379366

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
631169224
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986620521Removal KITRK2026-03-26
08800177380262Magic Angled AbutmentMAAH45123A2026-03-16
08800177380309Magic Angled AbutmentMAAH45115B2026-03-16
08800177380347Magic Angled AbutmentMAAH45123B2026-03-16
08800177380385Magic Angled AbutmentMAAN451152026-03-16
08800177380422Magic Angled AbutmentMAAN451232026-03-16
08800177380460Magic Angled AbutmentMAAH55115A2026-03-16
08800177380507Magic Angled AbutmentMAAH55123A2026-03-16
08800177380545Magic Angled AbutmentMAAH55115B2026-03-16
08800177380583Magic Angled AbutmentMAAH55123B2026-03-16
08800177380620Magic Angled AbutmentMAAN551152026-03-16
08800177380668Magic Angled AbutmentMAAN551232026-03-16
08800177388534Magic Multiunit AbutmentMACNB451052026-03-16
08800177388541Magic Multiunit AbutmentMACNB451102026-03-16
08800177388558Magic Multiunit AbutmentMACNB451152026-03-16
08800177388565Magic Multiunit AbutmentMACNB451202026-03-16
08800177388572Magic Multiunit AbutmentMACNB451252026-03-16
08800177388589Magic Multiunit AbutmentMACNB551052026-03-16
08800177388596Magic Multiunit AbutmentMACNB551102026-03-16
08800177388602Magic Multiunit AbutmentMACNB551152026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126046888EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046895EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046901EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046918EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046925EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046932EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046949EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046956EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046963EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046970EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046987EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046994EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047007EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047014EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047021EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047038EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047045EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047052EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047069EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
07392532281730ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
07392532281747ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
08809917132710Healing Abutment SystemOsstem Implant Co., Ltd.NHA2026-07-29
08800070223673Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223710Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223758Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223796Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070224236Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224274Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224311Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224359Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27