FDA.reportPublic FDA data

ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM

Primary DI
04719874670313
Brand
ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM
Company
INTAI TECHNOLOGY CORP.
Model
DI0FS14508
Device description
INTAI - E-system Implant - Ø 4.5mmL8.5mm
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
04719874670313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874670313047198746703134719874670313

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
04719874670283ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS140112026-04-22
04719874670290ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS140132026-04-22
04719874670306ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS140152026-04-22
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
07392532000430Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000447Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000874Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000942Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000959Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002731Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002748Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037115Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037122Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049613Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049620Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049637Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049644Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049651Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049668Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532062841Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532036965Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036972Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036989Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532049576ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532049583ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066047ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066054ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067778ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067785ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532000928ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532000935ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002649ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002656ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002663ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16