FDA.reportPublic FDA data

Meg-Rhein Overdenture

Primary DI
08806388269303
Brand
Meg-Rhein Overdenture
Company
Megagen Implant Co. Ltd
Model
ADR05P
Catalog number
ADR05PA
Published
2023-11-08
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
K150537000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150537000MiNi Internal Implant SystemMegagen Implant Co., Ltd.2015-07-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388269303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388269303088063882693038806388269303

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
08806388287857Healing AbutmentAOHS50704AOHS50704T2023-06-30
08806388287819Healing AbutmentAOHS50655AOHS50655T2023-06-08
08806388287826Healing AbutmentAOHS50657AOHS50657T2023-06-08
08806388287833Healing AbutmentAOHS50702AOHS50702T2023-06-08
08806388287840Healing AbutmentAOHS50703AOHS50703T2023-06-08
08806388287864Healing AbutmentAOHS50705AOHS50705T2023-06-08
08806388287871Healing AbutmentAOHS50707AOHS50707T2023-06-08
08806388287888Healing AbutmentAOHS60702AOHS60702T2023-06-08
08806388287895Healing AbutmentAOHS60703AOHS60703T2023-06-08
08806388287901Healing AbutmentAOHS60704AOHS60704T2023-06-08
08806388287918Healing AbutmentAOHS60705AOHS60705T2023-06-08
08806388287925Healing AbutmentAOHS60707AOHS60707T2023-06-08
08806388287932Healing AbutmentAOHS60802AOHS60802T2023-06-08
08806388287949Healing AbutmentAOHS60803AOHS60803T2023-06-08
08806388288359Healing AbutmentAOHS50654NAOHS50654NT2023-06-08
08806388288366Healing AbutmentAOHS50655NAOHS50655NT2023-06-08
08806388288373Healing AbutmentAOHS50657NAOHS50657NT2023-06-08
08806388288380Healing AbutmentAOHS50702NAOHS50702NT2023-06-08
08806388288397Healing AbutmentAOHS50703NAOHS50703NT2023-06-08
08806388288403Healing AbutmentAOHS50704NAOHS50704NT2023-06-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07290118177425NAUNIQA DENTAL LTDNHA2026-07-19
07290118177432NAUNIQA DENTAL LTDNHA2026-07-19
07290118177449NAUNIQA DENTAL LTDNHA2026-07-19
07290118177456NAUNIQA DENTAL LTDNHA2026-07-19
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