FDA.reportPublic FDA data

ALLOY PRIMER

Primary DI
EKUR000064KA1
Brand
ALLOY PRIMER
Company
KURARAY NORITAKE DENTAL INC.
Model
#064-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
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012436000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012436000MODIFICATION TO ALLOY PRIMERKuraray Medical, Inc.2001-09-04KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKUR000064KA1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis priming agentA material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as a primer and includes compounds such as an unfilled-resin or silane-based agent; an applicator may also be included. The material is not intended to be used as a dentine bonding or dentine priming agent. 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
00850194007763Zr-P BottleVista DentalKLE2026-06-04
08809518342105Hi-Bond UniversalMEDICLUS CO.,LTDKLE2026-06-01
00197998024269Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024276Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024290Solventum™Solventum Germany GmbHKLE2026-05-08
J017CVMLP0140VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLP0240VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
08809262954029FineEtchSpident Co., Ltd.KLE2026-04-20
306058610668163M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
306058610669083M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
506058610362573M™ Adper™3M COMPANYKLE2026-04-17
D0019064140LucitoneDentsply International Inc.KLE2025-07-01
D0019064150LucitoneDentsply International Inc.KLE2025-07-01
D0019064160LucitoneDentsply International Inc.KLE2025-07-01
D0019064170LucitoneDentsply International Inc.KLE2025-07-01
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCKLE2025-03-12
00195062068508OptiBond Universal 360Kerr CorporationKLE2024-06-25
07615208298536Monobond PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2024-01-24
D0019064020LucitoneDentsply International Inc.KLE2023-11-14
D0019064030LucitoneDentsply International Inc.KLE2023-11-14
D0019064040LucitoneDentsply International Inc.KLE2023-11-14
D0019064050LucitoneDentsply International Inc.KLE2023-11-14
07615208293128Adhese 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208295375Monobond Etch & PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296136Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296143Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297362ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297379ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06