FDA.reportPublic FDA data

K-ETCHANT GEL

Primary DI
EKUR000013KA1
Brand
K-ETCHANT GEL
Company
KURARAY NORITAKE DENTAL INC.
Model
#013-KA
Published
2017-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062409000K-ETCHANT GELKuraray Medical, Inc.2006-11-08EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKUR000013KA1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

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
08685313736208DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBF2026-08-25
08685313736215DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBF2026-08-25
08685313736222DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBF2026-08-25
08809518345663One-Temp FlowMEDICLUS CO.,LTDEBF2026-08-12
08809518345670One-Temp FlowMEDICLUS CO.,LTDEBF2026-08-12
00810222900046Midas Restore - C2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
07615208476804Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476811Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476828Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476835Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476842Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477658Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477665Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477672Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477689Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477696Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477702Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29