FDA.reportPublic FDA data

Magic Multiunit Abutment

Primary DI
08800177388558
Brand
Magic Multiunit Abutment
Company
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Model
MACNB45115
Published
2026-03-16
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
K220517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220517000IBS SystemInnobiosurg Co., Ltd.2022-12-20DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800177388558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800177388558088001773885588800177388558

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
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
08800177388619Magic Multiunit AbutmentMACNB551202026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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