Healing Abutment

Primary DI
08800293000679
Brand
Healing Abutment
Company
Megagen Implant Co. Ltd
Model
AROHSN60705N
Catalog number
AROHSN60705NT
Device description
BLUEDIAMOND
Published
2025-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
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
K210826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210826000Healing Abutment, Cover ScrewMegagen Implant Co., Ltd.2022-02-03NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800293000679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800293000679088002930006798800293000679

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

Regulatory Flags#

DUNS number
687388178
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
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
08806388247325Multi-unit Angled AbutmentMUAAON1745TMUAAON1745TC2021-11-18
08806388250455Multi-unit Angled AbutmentMUAARH1745LMUAARH1745LC2021-11-18
08806388255986Multi-unit Angled AbutmentMUAAOH1745TMUAAOH1745TC2021-11-18
08809708759935Multi-unit Angled AbutmentMUAARN1745LMUAARN1745LC2021-11-18

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Primary DI, Brand, Company table
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