FDA.reportPublic FDA data

Multi-unit Abutment Package

Primary DI
08806388243778
Brand
Multi-unit Abutment Package
Company
Megagen Implant Co. Ltd
Model
MUAAON0045
Catalog number
MUAAON0045P
Device description
C=4.5/ Straight/ M2
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
08806388243778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388243778088063882437788806388243778

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
false
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
08806388243662Multi-unit Abutment PackageMUAAOH1725MUAAOH1725P2021-11-18
08806388243679Multi-unit Abutment PackageMUAAOH1735MUAAOH1735P2021-11-18
08806388243686Multi-unit Abutment PackageMUAAOH3035MUAAOH3035P2021-11-18
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
08806388243785Multi-unit Abutment PackageMUAARH1725MUAARH1725P2021-11-18
08806388243792Multi-unit Abutment PackageMUAARH1735MUAARH1735P2021-11-18
08806388243808Multi-unit Abutment PackageMUAARH3035MUAARH3035P2021-11-18
08806388243815Multi-unit Abutment PackageMUAARH3045MUAARH3045P2021-11-18
08806388243822Multi-unit Abutment PackageMUAARN0015MUAARN0015P2021-11-18
08806388243839Multi-unit Abutment PackageMUAARN0025MUAARN0025P2021-11-18
08806388243846Multi-unit Abutment PackageMUAARN0035MUAARN0035P2021-11-18
08806388243853Multi-unit Abutment PackageMUAARN0045MUAARN0045P2021-11-18
08806388243860Multi-unit Abutment PackageMUAARN1725MUAARN1725P2021-11-18
08806388243877Multi-unit Abutment PackageMUAARN1735MUAARN1735P2021-11-18
08806388243884Multi-unit Abutment PackageMUAARN3035MUAARN3035P2021-11-18
08806388243891Multi-unit Abutment PackageMUAARN3045MUAARN3045P2021-11-18

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Primary DI, Brand, Company table
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