FDA.reportPublic FDA data

Meg-Rhein Overdenture

Primary DI
08806388262922
Brand
Meg-Rhein Overdenture
Company
Megagen Implant Co. Ltd
Model
ARODR03PA
Catalog number
ARODR03PA
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
08806388262922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388262922088063882629228806388262922

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
08806388216789AnyRidge Internal FixtureFALIHX6007FALIHX6007C2015-06-24
08806388216840XPEED AnyRidge Internal FixtureFALIHX6507FALIHX6507C2015-06-24
08806388216901XPEED AnyRidge Internal FixtureFALIHX7007FALIHX7007C2015-06-24
08806388216963XPEED AnyRidge Internal FixtureFALIHX7507FALIHX7507C2015-06-24
08806388217021XPEED AnyRidge Internal FixtureFALIHX8007FALIHX8007C2015-06-24
08806388217571XPEED AnyRidge Internal FixtureFANIHX4507FANIHX4507C2015-06-23
08806388217649XPEED AnyRidge Internal FixtureFANIHX5007FANIHX5007C2015-06-23
08806388217854XPEED AnyRidge Internal FixtureFANIHX5507FANIHX5507C2015-06-23
08806388220588AnyOne Internal FixtureIF3507IF3507C2015-06-26
08806388220595AnyOne Internal FixtureIF3507IF35072015-06-26
08806388220601AnyOne Internal FixtureIF3508IF3508C2015-06-26
08806388220618AnyOne Internal FixtureIF3508IF35082015-06-26
08806388220625AnyOne Internal FixtureIF3510IF3510C2015-06-26
08806388220632AnyOne Internal FixtureIF3510IF35102015-06-26
08806388220649AnyOne Internal FixtureIF3511IF3511C2015-06-26
08806388220656AnyOne Internal FixtureIF3511IF35112015-06-26
08806388220663AnyOne Internal FixtureIF3513IF3513C2015-06-26
08806388220670AnyOne Internal FixtureIF3513IF35132015-06-26
08806388220687AnyOne Internal FixtureIF3515IF3515C2015-06-26
08806388220694AnyOne Internal FixtureIF3515IF35152015-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260516873062SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873079SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516873338SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516873352SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873369SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516874557SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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