FDA.reportPublic FDA data

Multi-unit Angled Abutment

Primary DI
08806388247325
Brand
Multi-unit Angled Abutment
Company
Megagen Implant Co. Ltd
Model
MUAAON1745T
Catalog number
MUAAON1745TC
Device description
C=4.5/ A=17/ Non-Hex
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
08806388247325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388247325088063882473258806388247325

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
08806388243402Multi-unit Angled AbutmentMUAAOH1725TMUAAOH1725TC2021-11-18
08806388243419Multi-unit Angled AbutmentMUAAOH1735TMUAAOH1735TC2021-11-18
08806388243426Multi-unit Angled AbutmentMUAAOH3035TMUAAOH3035TC2021-11-18
08806388243433Multi-unit Angled AbutmentMUAAOH3045TMUAAOH3045TC2021-11-18
08806388243440Multi-unit Angled AbutmentMUAAON1725TMUAAON1725TC2021-11-18
08806388243457Multi-unit Angled AbutmentMUAAON1735TMUAAON1735TC2021-11-18
08806388243464Multi-unit Angled AbutmentMUAAON3035TMUAAON3035TC2021-11-18
08806388243471Multi-unit Angled AbutmentMUAAON3045TMUAAON3045TC2021-11-18
08806388243488Multi-unit Angled AbutmentMUAARH1725LMUAARH1725LC2021-11-18
08806388243495Multi-unit Angled AbutmentMUAARH1735LMUAARH1735LC2021-11-18
08806388243501Multi-unit Angled AbutmentMUAARH3035LMUAARH3035LC2021-11-18
08806388243518Multi-unit Angled AbutmentMUAARH3045LMUAARH3045LC2021-11-18
08806388243525Multi-unit Angled AbutmentMUAARN1725LMUAARN1725LC2021-11-18
08806388243532Multi-unit Angled AbutmentMUAARN1735LMUAARN1735LC2021-11-18
08806388243549Multi-unit Angled AbutmentMUAARN3035LMUAARN3035LC2021-11-18
08806388243556Multi-unit Angled AbutmentMUAARN3045LMUAARN3045LC2021-11-18
08806388250455Multi-unit Angled AbutmentMUAARH1745LMUAARH1745LC2021-11-18
08806388255986Multi-unit Angled AbutmentMUAAOH1745TMUAAOH1745TC2021-11-18
08809708759935Multi-unit Angled AbutmentMUAARN1745LMUAARN1745LC2021-11-18
08806388266173ZrGEN AbutmentARZXM503825ARZXM503825.MTN2024-01-31

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Primary DI, Brand, Company table
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00810126046949EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046956EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046963EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
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00810126046994EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
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00810126047014EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047021EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047038EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047045EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047052EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047069EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
07392532281730ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
07392532281747ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
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08800070224311Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224359Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27