FDA.reportPublic FDA data

Multi-unit Abutment Package

Primary DI
08806388243686
Brand
Multi-unit Abutment Package
Company
Megagen Implant Co. Ltd
Model
MUAAOH3035
Catalog number
MUAAOH3035P
Device description
C=3.5/ A=30/ Hex 2.5
Published
2021-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
K203808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203808000Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.2021-10-20NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388243686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388243686088063882436868806388243686

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806388277926Multi-unit Abutment PackageMUAARONN1725MUAARONN1725P2021-11-18
08806388220311Angled AbutmentIAA3515IAA3515T2021-07-01
08806388220328Angled AbutmentIAA3525IAA3525T2021-07-01
08806388246564AnyOne Onestage FixtureOSF3507OSF3507H2021-07-01
08806388246571AnyOne Onestage FixtureOSF3508OSF3508H2021-07-01
08806388246588AnyOne Onestage FixtureOSF3510OSF3510H2021-07-01
08806388246922AnyOne Onestage FixtureOSF3507LOSF3507LH2021-07-01
08806388246939AnyOne Onestage FixtureOSF3508LOSF3508LH2021-07-01
08806388246946AnyOne Onestage FixtureOSF3510LOSF3510LH2021-07-01
08806388243662Multi-unit Abutment PackageMUAAOH1725MUAAOH1725P2021-11-18
08806388243679Multi-unit Abutment PackageMUAAOH1735MUAAOH1735P2021-11-18
08806388243693Multi-unit Abutment PackageMUAAOH3045MUAAOH3045P2021-11-18
08806388243709Multi-unit Abutment PackageMUAAON1725MUAAON1725P2021-11-18
08806388243747Multi-unit Abutment PackageMUAAON0015MUAAON0015P2021-11-18
08806388243754Multi-unit Abutment PackageMUAAON0025MUAAON0025P2021-11-18
08806388243761Multi-unit Abutment PackageMUAAON0035MUAAON0035P2021-11-18
08806388243778Multi-unit Abutment PackageMUAAON0045MUAAON0045P2021-11-18
08806388243785Multi-unit Abutment PackageMUAARH1725MUAARH1725P2021-11-18
08806388243792Multi-unit Abutment PackageMUAARH1735MUAARH1735P2021-11-18
08806388243808Multi-unit Abutment PackageMUAARH3035MUAARH3035P2021-11-18

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Primary DI, Brand, Company table
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