FDA.reportPublic FDA data

Scan Healing Abutment

Primary DI
08806388261857
Brand
Scan Healing Abutment
Company
Megagen Implant Co. Ltd
Model
ARRSH6007T
Published
2024-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
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
K234142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234142000TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.2024-09-18NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388261857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388261857088063882618578806388261857

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687388178
Device count
1
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
08806388213320AnyOne External FixtureEF4508EF4508P2021-11-18
08806388213368AnyOne External FixtureEF4510EF4510P2021-11-18
08806388213405AnyOne External FixtureEF4511EF4511P2021-11-18
08806388213443AnyOne External FixtureEF4513EF4513P2021-11-18
08806388213481AnyOne External FixtureEF4515EF4515P2021-11-18
08806388213504AnyOne External FixtureEF5007EF5007P2021-11-18
08806388213528AnyOne External FixtureEF5008EF5008P2021-11-18
08806388213542AnyOne External FixtureEF5010EF5010P2021-11-18
08806388213566AnyOne External FixtureEF5011EF5011P2021-11-18
08806388213580AnyOne External FixtureEF5013EF5013P2021-11-18
08806388213603AnyOne External FixtureEF5015EF5015P2021-11-18
08806388213740AnyOne External FixtureEF6007EF6007P2021-11-18
08806388213764AnyOne External FixtureEF6008EF6008P2021-11-18
08806388213788AnyOne External FixtureEF6010EF6010P2021-11-18
08806388213801AnyOne External FixtureEF6011EF6011P2021-11-18
08806388213825AnyOne External FixtureEF6013EF6013P2021-11-18
08806388213849AnyOne External FixtureEF6015EF6015P2021-11-18
08806388229345Multi-unit Angled AbutmentMU50117NMU50117NT2021-11-18
08806388229352Multi-unit Angled AbutmentMU50129HMU50129HT2021-11-18
08806388229369Multi-unit Angled AbutmentMU50129NMU50129NT2021-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05712821017277Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017284Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017291Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017307Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017314Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017321Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017338Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017345Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017352Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
D99025HMINIOA0Omnibut, Hiossen Mini, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HMINIOA140Omnibut, Hiossen Mini, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HREGOA0Omnibut, Hiossen Regular, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HREGOA140Omnibut, Hiossen Regular, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025MGAOA0Omnibut, MegaGen AnyRidge, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025MGAOA140Omnibut, MegaGen AnyRidge, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26