FDA.reportPublic FDA data

KATANA™ Zirconia ONE

Primary DI
EKUR1259699KA0
Brand
KATANA™ Zirconia ONE
Company
KURARAY NORITAKE DENTAL INC.
Model
125-9699KA
Device description
For IMPLANT L NW
Published
2024-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233285000KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.2024-05-24NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKUR1259699KA0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
697119498
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EKUR1259852KA0KATANA™ Zirconia125-9852KA2026-03-01
EKUR1259863KA0KATANA™ Zirconia125-9863KA2026-03-01
EKUR1259874KA0KATANA™ Zirconia125-9874KA2026-03-01
EKUR1259882KA0KATANA™ Zirconia125-9882KA2026-03-01
EKUR1259893KA0KATANA™ Zirconia125-9893KA2026-03-01
EKUR1259904KA0KATANA™ Zirconia125-9904KA2026-03-01
EKUR1259915KA0KATANA™ Zirconia125-9915KA2026-03-01
EKUR004101KA1KATANA AVENCIA Block#4101-KA2019-04-30
EKUR004102KA1KATANA AVENCIA Block#4102-KA2019-04-30
EKUR004103KA1KATANA AVENCIA Block#4103-KA2019-04-30
EKUR004147KA1KATANA AVENCIA Block#4147-KA2019-04-30
EKUR004148KA1KATANA AVENCIA Block#4148-KA2019-04-30
EKUR004149KA1KATANA AVENCIA Block#4149-KA2019-04-30
EKUR1045931KA0CERABIEN™ ZR104-5931KA2026-01-12
EKUR1045941KA0CERABIEN™ ZR104-5941KA2026-01-12
EKUR1045951KA0CERABIEN™ ZR104-5951KA2026-01-12
EKUR1045961KA0CERABIEN™ ZR104-5961KA2026-01-12
EKUR1045971KA0CERABIEN™ ZR104-5971KA2026-01-12
EKUR1045982KA0CERABIEN™ ZR104-5982KA2026-01-12
EKUR1045992KA0CERABIEN™ ZR104-5992KA2026-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
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