FDA.reportPublic FDA data

XPEED AnyRidge Internal Fixture

Primary DI
08809822766970
Brand
XPEED AnyRidge Internal Fixture
Company
Megagen Implant Co. Ltd
Model
AR384511
Catalog number
AR384511XAC
Device description
XPEED AnyRidge Internal Implant System (C3.8) Ø4.5/ L11.5
Published
2023-06-02
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
K140091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140091000XPEED ANYRIDGE INTERNAL IMPLANT SYSYEMMegagen Implant Co., Ltd.2014-12-12DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809822766970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809822766970088098227669708809822766970

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.

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
08800352213811Fixture DriverARFDUARFDU2026-05-26
08800352213828Fixture DriverARFDSARFDS2026-05-26
08800352213835Fixture DriverARFDLARFDL2026-05-26
08800292994085Impression CopingAONIP5009HAONIP5009HT2026-04-30
08800292994092Impression CopingAONIP5012HAONIP5012HT2026-04-30
08800292994108Impression CopingAONIP5015HAONIP5015HT2026-04-30
08800292994115Impression CopingAONIP6009HAONIP6009HT2026-04-30
08800292994122Impression CopingAONIP6012HAONIP6012HT2026-04-30
08800292994139Impression CopingAONIP6015HAONIP6015HT2026-04-30
08800292994412Impression CopingARIENIPN5009ARIENIPN5009T2026-04-30
08800292994429Impression CopingARIENIPN5012ARIENIPN5012T2026-04-30
08800292994436Impression CopingARIENIPN5015ARIENIPN5015T2026-04-30
08800292994443Impression CopingAONIP5009NAONIP5009NT2026-04-30
08800292994450Impression CopingAONIP5012NAONIP5012NT2026-04-30
08800292994467Impression CopingAONIP5015NAONIP5015NT2026-04-30
08800292994474Impression CopingAONIP6009NAONIP6009NT2026-04-30
08800292994481Impression CopingAONIP6012NAONIP6012NT2026-04-30
08800292994498Impression CopingAONIP6015NAONIP6015NT2026-04-30
08809822769964N2N2 (Cart A Type)MC92-0001A2023-11-22
08809822769971N2N2 (Mount A Type)MC92-0002A2023-11-22

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