FDA.reportPublic FDA data

AnyOne External Fixture

Primary DI
08806388213566
Brand
AnyOne External Fixture
Company
Megagen Implant Co. Ltd
Model
EF5011
Catalog number
EF5011P
Device description
(C4.6) Ø5.0/ L11.5
Published
2021-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
K203554000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203554000AnyOne External Implant SystemMegagen Implant Co., Ltd.2021-08-28DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388213566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388213566088063882135668806388213566

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.

Regulatory Flags#

DUNS number
687388178
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806388213320AnyOne External FixtureEF4508EF4508P2021-11-18
08806388213368AnyOne External FixtureEF4510EF4510P2021-11-18
08806388213405AnyOne External FixtureEF4511EF4511P2021-11-18
08806388213443AnyOne External FixtureEF4513EF4513P2021-11-18
08806388213481AnyOne External FixtureEF4515EF4515P2021-11-18
08806388213504AnyOne External FixtureEF5007EF5007P2021-11-18
08806388213528AnyOne External FixtureEF5008EF5008P2021-11-18
08806388213542AnyOne External FixtureEF5010EF5010P2021-11-18
08806388213580AnyOne External FixtureEF5013EF5013P2021-11-18
08806388213603AnyOne External FixtureEF5015EF5015P2021-11-18
08806388213740AnyOne External FixtureEF6007EF6007P2021-11-18
08806388213764AnyOne External FixtureEF6008EF6008P2021-11-18
08806388213788AnyOne External FixtureEF6010EF6010P2021-11-18
08806388213801AnyOne External FixtureEF6011EF6011P2021-11-18
08806388213825AnyOne External FixtureEF6013EF6013P2021-11-18
08806388213849AnyOne External FixtureEF6015EF6015P2021-11-18
08806388229345Multi-unit Angled AbutmentMU50117NMU50117NT2021-11-18
08806388229352Multi-unit Angled AbutmentMU50129HMU50129HT2021-11-18
08806388229369Multi-unit Angled AbutmentMU50129NMU50129NT2021-11-18
08806388229406Multi-unit Angled AbutmentMU50217HMU50217HT2021-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230367ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230374ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230381ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230398ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26