FDA.reportPublic FDA data

HISC00

Primary DI
08800039307086
Brand
HISC00
Company
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Model
Cover Screw HISC00
Published
2018-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K162099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162099000IBS Implant System IIInnobiosurg Co., Ltd.2017-02-15DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800039307086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039307086088000393070868800039307086

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted 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 is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

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
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