FDA.reportPublic FDA data

AnyOne Onestage Fixture

Primary DI
08806388246588
Brand
AnyOne Onestage Fixture
Company
Megagen Implant Co. Ltd
Model
OSF3510
Catalog number
OSF3510H
Device description
Ø3.5/ L=10/ C=1.8
Published
2021-07-01
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
K210161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210161000AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.2021-06-22DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388246588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388246588088063882465888806388246588

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
08806388287857Healing AbutmentAOHS50704AOHS50704T2023-06-30
08806388287819Healing AbutmentAOHS50655AOHS50655T2023-06-08
08806388287826Healing AbutmentAOHS50657AOHS50657T2023-06-08
08806388287833Healing AbutmentAOHS50702AOHS50702T2023-06-08
08806388287840Healing AbutmentAOHS50703AOHS50703T2023-06-08
08806388287864Healing AbutmentAOHS50705AOHS50705T2023-06-08
08806388287871Healing AbutmentAOHS50707AOHS50707T2023-06-08
08806388287888Healing AbutmentAOHS60702AOHS60702T2023-06-08
08806388287895Healing AbutmentAOHS60703AOHS60703T2023-06-08
08806388287901Healing AbutmentAOHS60704AOHS60704T2023-06-08
08806388287918Healing AbutmentAOHS60705AOHS60705T2023-06-08
08806388287925Healing AbutmentAOHS60707AOHS60707T2023-06-08
08806388287932Healing AbutmentAOHS60802AOHS60802T2023-06-08
08806388287949Healing AbutmentAOHS60803AOHS60803T2023-06-08
08806388288359Healing AbutmentAOHS50654NAOHS50654NT2023-06-08
08806388288366Healing AbutmentAOHS50655NAOHS50655NT2023-06-08
08806388288373Healing AbutmentAOHS50657NAOHS50657NT2023-06-08
08806388288380Healing AbutmentAOHS50702NAOHS50702NT2023-06-08
08806388288397Healing AbutmentAOHS50703NAOHS50703NT2023-06-08
08806388288403Healing AbutmentAOHS50704NAOHS50704NT2023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126046871ET III Fixture SA Regular No MountHIOSSEN, INC.DZE2026-07-14
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
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
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26