FDA.reportPublic FDA data

Meg-Rhein Overdenture

Primary DI
08806388262816
Brand
Meg-Rhein Overdenture
Company
Megagen Implant Co. Ltd
Model
ARODR06P
Catalog number
ARODR06P
Published
2023-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K192614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192614000Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.2020-02-13NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388262816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388262816088063882628168806388262816

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687388178
Device count
1
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
08806388226221BCP EAGLE EYEMGSB0802MGSB08022015-06-29
08806388226238BCP EAGLE EYEMGSB0805MGSB08052015-06-29
08806388226245BCP EAGLE EYEMGSB0810MGSB08102015-06-29
08806388226252BCP EAGLE EYEMGSB0820MGSB08202015-06-29
08806388271504Mega-Oss BovineTMIOSG025IOSG0252018-10-15
08806388271511Mega-Oss BovineTMIOSG050IOSG0502018-10-15
08806388271528Mega-Oss BovineTMIOSG100IOSG1002018-10-15
08806388271535Mega-Oss BovineTMIOSG200IOSG2002018-10-15
08806388271542Mega-Oss BovineTMIOSG500IOSG5002018-10-15
08806388271559Mega-Oss BovineTMIOLG050IOLG0502018-10-15
08806388271566Mega-Oss BovineTMIOLG100IOLG1002018-10-15
08806388271573Mega-Oss BovineTMIOLG200IOLG2002018-10-15
08809977452445BLUEDIAMOND IMPLANTBDC410506C2026-09-04
08809977452469BLUEDIAMOND IMPLANTBDC410506DC2026-09-04
08809977452568BLUEDIAMOND IMPLANTBDC410706C2026-09-04
08809977452582BLUEDIAMOND IMPLANTBDC410706DC2026-09-04
08809977452681BLUEDIAMOND IMPLANTBDC410904C2026-09-04
08809977452704BLUEDIAMOND IMPLANTBDC410904DC2026-09-04
08809977452728BLUEDIAMOND IMPLANTBDC410906C2026-09-04
08809977452742BLUEDIAMOND IMPLANTBDC410906DC2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114711548prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-13
07290114711630prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-13
07290114712491prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-13
00842448118608TITAN IMPLANTS INCTITAN IMPLANT INCNHA2026-10-12
07290114710039Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710046prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710114prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710138prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710145prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710312Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710732Indirect Transfer 13mm open trayCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
08809984989040S-PlantIDIS CO.,LTDNHA2026-10-07
07290114712675prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712682prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712699prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712705prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712712prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712729prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712736prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712743prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712750prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
08809984970895S-PlantIDIS CO.,LTDNHA2026-10-07
08809984981518S-PlantI Dis Co., Ltd.NHA2026-10-07
D7702764233TRANSGINGIVAL HEALING CAP H3MMSWEDEN & MARTINA SPANHA2026-10-07
D7702764243TRANSGINGIVAL HEALING CAP H5MMSWEDEN & MARTINA SPANHA2026-10-07
05712821014696Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014702Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014719Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014726Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014733Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06