FDA.reportPublic FDA data

ExFeel Internal Fixture

Primary DI
08806388222568
Brand
ExFeel Internal Fixture
Company
Megagen Implant Co. Ltd
Model
ISDB4107E
Catalog number
ISDB4107E
Device description
ExFeel Internal
Published
2023-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K052369000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052369000EXFEEL IMPLANT SYSTEMMegagen Co., Ltd.2006-01-10DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388222568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388222568088063882225688806388222568

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
08806388216789AnyRidge Internal FixtureFALIHX6007FALIHX6007C2015-06-24
08806388216840XPEED AnyRidge Internal FixtureFALIHX6507FALIHX6507C2015-06-24
08806388216901XPEED AnyRidge Internal FixtureFALIHX7007FALIHX7007C2015-06-24
08806388216963XPEED AnyRidge Internal FixtureFALIHX7507FALIHX7507C2015-06-24
08806388217021XPEED AnyRidge Internal FixtureFALIHX8007FALIHX8007C2015-06-24
08806388217571XPEED AnyRidge Internal FixtureFANIHX4507FANIHX4507C2015-06-23
08806388217649XPEED AnyRidge Internal FixtureFANIHX5007FANIHX5007C2015-06-23
08806388217854XPEED AnyRidge Internal FixtureFANIHX5507FANIHX5507C2015-06-23
08806388220588AnyOne Internal FixtureIF3507IF3507C2015-06-26
08806388220595AnyOne Internal FixtureIF3507IF35072015-06-26
08806388220601AnyOne Internal FixtureIF3508IF3508C2015-06-26
08806388220618AnyOne Internal FixtureIF3508IF35082015-06-26
08806388220625AnyOne Internal FixtureIF3510IF3510C2015-06-26
08806388220632AnyOne Internal FixtureIF3510IF35102015-06-26
08806388220649AnyOne Internal FixtureIF3511IF3511C2015-06-26
08806388220656AnyOne Internal FixtureIF3511IF35112015-06-26
08806388220663AnyOne Internal FixtureIF3513IF3513C2015-06-26
08806388220670AnyOne Internal FixtureIF3513IF35132015-06-26
08806388220687AnyOne Internal FixtureIF3515IF3515C2015-06-26
08806388220694AnyOne Internal FixtureIF3515IF35152015-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229088ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229095ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229101ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229118ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070203156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04