FDA.reportPublic FDA data

Magic Multiunit Abutment Impression coping Guide Pin (Transfer type)

Primary DI
08800039399371
Brand
Magic Multiunit Abutment Impression coping Guide Pin (Transfer type)
Company
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Model
MATICGP
Published
2020-06-23
Public version status
Update
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
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
K192197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192197000Magicore II SystemInnobiosurg Co., Ltd.2020-04-28DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800039399371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039399371088000393993718800039399371

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
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710411Healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114712156Abutments-AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712613Titanium-basesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
05712821017123Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017130Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017147Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017154Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017161Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017178Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017185Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017192Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017208Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017215Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017222Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017239Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017246Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017253Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017260Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26