FDA.reportPublic FDA data

ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM

Primary DI
04719874670283
Brand
ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM
Company
INTAI TECHNOLOGY CORP.
Model
DI0FS14011
Device description
INTAI - E-system Implant - Ø 4mmL11.5mm
Published
2026-04-22
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
K122804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122804000ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMIntai Technology Corp.2013-05-20DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719874670283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874670283047198746702834719874670283

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Regulatory Flags#

DUNS number
658683227
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
04719874670443ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0CS3901L2026-05-04
04719874670207ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS050152026-04-22
04719874670221ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS135102026-04-22
04719874670238ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS135112026-04-22
04719874670245ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS135132026-04-22
04719874670252ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS135152026-04-22
04719874670269ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS140082026-04-22
04719874670276ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS140102026-04-22
04719874670290ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS140132026-04-22
04719874670306ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS140152026-04-22
04719874670313ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS145082026-04-22
04719874670320ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS145102026-04-22
04719874670214ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS135082026-04-20
04719874670337ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS142112026-04-20
04719874670344ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS145132026-04-20
04719874670351ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS145152026-04-20
04719874670368ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS150082026-04-20
04719874670375ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS150102026-04-20
04719874670382ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS150112026-04-20
04719874670399ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS150132026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08809822767892AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767908AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767922AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767946AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767953AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12