AIMGEN MAX ATHA-6570-PA

GUDID 08800024953199

AIMGEN MAX Healing Abutment Φ6.5/H7.0

Achimhai Medical Corporation

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08800024953199
NIH Device Record Key53a018e5-e3e6-4979-b357-1a0ee87bb67d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIMGEN MAX
Version Model NumberATHA6570
Catalog NumberATHA-6570-PA
Company DUNS694197900
Company NameAchimhai Medical Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108800024953199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-02
Device Publish Date2021-11-24

On-Brand Devices [AIMGEN MAX]

08800024954639AIMGEN MAX Implant System Φ3.5/L8.0
08800024953816AIMGEN MAX Healing Abutment Φ7.5/H7.0
08800024953809AIMGEN MAX Healing Abutment Φ7.5/H3.5
08800024953748AIMGEN MAX Healing Abutment Φ7.5/H5.0
08800024953724AIMGEN MAX Healing Abutment Φ3.0/H3.5
08800024953670AIMGEN MAX Healing Abutment Φ3.5/H3.5
08800024953618AIMGEN MAX Implant System Φ4.2/L8.0
08800024953557AIMGEN MAX Implant System Φ4.2/L10.0
08800024953540AIMGEN MAX Implant System Φ4.2/L7.0
08800024953496AIMGEN MAX Implant System Φ5.1/L8.0
08800024953489AIMGEN MAX Implant System Φ4.6/L15.0
08800024953472AIMGEN MAX Implant System Φ4.6/L11.0
08800024953465AIMGEN MAX Implant System Φ4.6/L8.0
08800024953458AIMGEN MAX Implant System Φ4.2/L15.0
08800024953441AIMGEN MAX Implant System Φ4.2/L11.0
08800024953434AIMGEN MAX Implant System Φ5.1/L10.0
08800024953427AIMGEN MAX Implant System Φ5.1/L7.0
08800024953410AIMGEN MAX Implant System Φ4.6/L13.0
08800024953403AIMGEN MAX Implant System Φ4.6/L10.0
08800024953397AIMGEN MAX Implant System Φ4.6/L7.0
08800024953380AIMGEN MAX Implant System Φ4.2/L13.0
08800024953373AIMGEN MAX Internal Fixture Φ3.2/L14.5
08800024953366AIMGEN MAX Internal Fixture Φ3.2/L11.0
08800024953335AIMGEN MAX Implant System Φ5.5/L10.0
08800024953328AIMGEN MAX Implant System Φ5.5/L7.0
08800024953311AIMGEN MAX Cover screw M1.4
08800024953304AIMGEN MAX Internal Fixture Φ3.2/L12.5
08800024953298AIMGEN MAX Internal Fixture Φ3.2/L9.5
08800024953267AIMGEN MAX Implant System Φ5.5/L8.0
08800024953250AIMGEN MAX Healing Abutment Φ6.5/H5.0
08800024953243AIMGEN MAX Healing Abutment Φ5.5/H7.0
08800024953236AIMGEN MAX Healing Abutment Φ5.5/H3.5
08800024953229AIMGEN MAX Healing Abutment Φ4.5/H5.0
08800024953212AIMGEN MAX Healing Abutment Φ4.0/H7.0
08800024953205AIMGEN MAX Healing Abutment Φ4.0/H3.5
08800024953199AIMGEN MAX Healing Abutment Φ6.5/H7.0
08800024953182AIMGEN MAX Healing Abutment Φ6.5/H3.5
08800024953175AIMGEN MAX Healing Abutment Φ5.5/H5.0
08800024953168AIMGEN MAX Healing Abutment Φ4.5/H7.0
08800024953151AIMGEN MAX Healing Abutment Φ4.5/H3.5
08800024953144AIMGEN MAX Healing Abutment Φ4.0/H5.0
08800024954127AIMGEN MAX Implant System Φ3.5/L14.5
08800024954110AIMGEN MAX Implant System Φ3.5/L12.5
08800024954103AIMGEN MAX Implant System Φ3.5/L11.0
08800024954097AIMGEN MAX Implant System Φ3.5/L9.5
08800024954073AIMGEN MAX Implant System Φ3.5/L8.0
08800024954066AIMGEN MAX Implant System Φ3.5/L7.0
08800024933610AIMGEN MAX Implant System Φ3.2/L11.0
08800024933597AIMGEN MAX Implant System Φ3.2/L10.0
08800024928722AIMGEN MAX Implant System Φ3.2/L8.0
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