FDA.reportPublic FDA data

Magicore

Primary DI
08800177355239
Brand
Magicore
Company
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Model
501M5508
Published
2022-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212517000Magicore SystemInnobiosurg Co., Ltd.2021-10-15DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800177355239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800177355239088001773552398800177355239

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

Regulatory Flags#

DUNS number
631169224
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
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
00810126046871ET III Fixture SA Regular No MountHIOSSEN, INC.DZE2026-07-14
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092184394PreatPreat CorporationNHA2025-07-24
08806388277483Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388286973Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388286980Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388286997Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287000Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287017Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287024Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287031Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287048Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287055Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287062Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287079Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287086Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287093Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
0880638828710908806388287109Megagen Implant Co. LtdNHA2023-06-08
08806388287116Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287123Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287130Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287147Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287154Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287161Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287178Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287185Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287192Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287208Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08
08806388287215Healing AbutmentMegagen Implant Co. LtdNHA2023-06-08