FDA.reportPublic FDA data

Abutment Screw

Primary DI
08809822765508
Brand
Abutment Screw
Company
Megagen Implant Co. Ltd
Model
AROAS16BL
Catalog number
AROAS16BL
Device description
BLUEDIAMOND IMPLANT System M1.6/ Long
Published
2023-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211812000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211812000BLUEDIAMOND IMPLANT, Abutment ScrewMegagen Implant Co., Ltd.2023-01-06DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809822765508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809822765508088098227655088809822765508

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
08806388205226Esthetic Healing AbutmentAEHR402AEHR4022021-11-18
08806388205233Esthetic Healing AbutmentAEHR403AEHR4032021-11-18
08806388205240Esthetic Healing AbutmentAEHR404AEHR4042021-11-18
08806388205257Esthetic Healing AbutmentAEHS302AEHS3022021-11-18
08806388205264Esthetic Healing AbutmentAEHS303AEHS3032021-11-18
08806388205271Esthetic Healing AbutmentAEHS304AEHS3042021-11-18
08806388205288Esthetic Healing AbutmentAEHW502AEHW5022021-11-18
08806388205295Esthetic Healing AbutmentAEHW503AEHW5032021-11-18
08806388205301Esthetic Healing AbutmentAEHW504AEHW5042021-11-18
08806388213023AnyOne External FixtureEF3507EF3507P2021-11-18
08806388213047AnyOne External FixtureEF3508EF3508P2021-11-18
08806388213061AnyOne External FixtureEF3510EF3510P2021-11-18
08806388213085AnyOne External FixtureEF3511EF3511P2021-11-18
08806388213108AnyOne External FixtureEF3513EF3513P2021-11-18
08806388213122AnyOne External FixtureEF3515EF3515P2021-11-18
08806388213146AnyOne External FixtureEF4007EF4007P2021-11-18
08806388213160AnyOne External FixtureEF4008EF4008P2021-11-18
08806388213184AnyOne External FixtureEF4010EF4010P2021-11-18
08806388213207AnyOne External FixtureEF4011EF4011P2021-11-18
08806388213221AnyOne External FixtureEF4013EF4013P2021-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806388205226Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205226Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205233Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205233Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205240Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205240Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205257Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205257Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205264Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205264Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205271Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205271Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205288Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205288Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205295Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205295Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205301Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205301Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388213023AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213023AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213047AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213047AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213061AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213061AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213085AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213085AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213108AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213108AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213122AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213122AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18