FDA.reportPublic FDA data

AIMGEN MAX

Primary DI
08800024953267
Brand
AIMGEN MAX
Company
Achimhai Medical Corporation
Model
PFX-5508SS
Catalog number
PFX-5508SS-CA
Device description
AIMGEN MAX Implant System Φ5.5/L8.0
Published
2021-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172630000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172630000Kisses Plus Implant SystemAchimhai Medical Corporation2018-04-03DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800024953267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800024953267088000249532678800024953267

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694197900
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800024957579AIMGEN MAXAMA-3530AMA-3530-PA2022-07-05
08800024957586AIMGEN MAXKTA-MKTA-M-PA2022-07-05
08800024957593AIMGEN MAXATBA30ABA-3530-PA2022-07-05
08800024957609AIMGEN MAXTBD24SABD-24S-PA2022-07-05
08800024957616AIMGEN MAXTEDI20SAED-20S-PA2022-07-05
08800024957623AIMGEN MAXTEDI20LAED-20L-PA2022-07-05
08800024957630AIMGEN MAXATW-CNATW-CN-PA2022-07-05
08800024957647AIMGEN MAXKIT-MKIT-M-PA2022-07-05
08800024957654AIMGEN MAXAMS-15AMS-15-PA2022-07-05
08800024957661AIMGEN MAXAMS-25AMS-25-PA2022-07-05
08800024957678AIMGEN MAXAMS-35AMS-35-PA2022-07-05
08800024957685AIMGEN MAXKMDA351055HMDA-351055H-PA2022-07-05
08800024957692AIMGEN MAXKMDA351555HMDA-351555H-PA2022-07-05
08800024953908AIMGEN MAXATBA00ABA-3500-PA2022-04-05
08800024953915AIMGEN MAXATBA10ABA-3510-PA2022-04-05
08800024953922AIMGEN MAXATBA20ABA-3520-PA2022-04-05
08800024953939AIMGEN MAXBACABC-0-P2022-04-05
08800024953946AIMGEN MAXTBD24LABD-24L-PA2022-04-05
08800024953960AIMGEN MAXATBLAABL-00-P2022-04-05
08800024917641AIMGEN MAXATDA552570HADA-552570H-PA2022-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200627Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200634Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200641Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200658Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200665Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200672Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200689Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200696Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200702Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200719Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200726Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200733Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200740Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200757Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200764Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200771Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200788Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200795Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200801Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200818Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200825Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28