KURARAY NORITAKE DENTAL INC. MIYOSHI PLANT

FDA Device Registration & Listing · MIYOSHI Aichi, JP · Registration 9614705

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9614705
FEI Number
3009523116
Entity Name
KURARAY NORITAKE DENTAL INC. MIYOSHI PLANT
City/State/Country
MIYOSHI Aichi, JP
Establishment Address
300 HIGASHIYAMA, MIYOSHI-CHO, MIYOSHI Aichi 470-0293, JP
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
KURARAY NORITAKE DENTAL INC. (Owner Number: 10031961)
Owner / Operator Contact Address
1621 SAKAZU, KURASHIKI, JP-33 710-0801, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K884356
PMA Number
N/A

All Registered Proprietary Names

CZR PRESS Esthetic White Kit CZR PRESS CZR PRESS LF CZR PRESS Trial-H Kit EX-3 PRESS TRIAL KIT H2 EX-3 PRESS TRIAL KIT L1 EX-3 PRESS EX-3 PRESS LF ESTHETIC WHITE KIT EX-3 PRESS LF ESTHETIC WHITE LAYERING KIT EX-3 PRESS LF EX-3 PRESS TRIAL KIT L2 EX-3 PRESS TRIAL KIT H1 KATANA Zirconia Noritake Super Porcelain EX-3 CERABIEN MiLai Noritake Super Porcelain Ti-22 CERABIEN KATANA Zirconia ONE For IMPLANT NORITAKE DENTAL SUPPLY CO. LTD CERABIEN MiLai Noritake Super Porcelain EX-3 Noritake Super Porcelain EX-3 EX-3 PRESS LF Noritake Super Porcelain EX-3 CERABIEN ZR CERABIEN ZR TRIAL KIT SS NV1120 CERABIEN ZR SS ESTHETIC WHITE KIT CERABIEN ZR SS BASIC FULL KIT CERABIEN ZR VALUE SHADE FULL KIT CERABIEN ZR TRIAL KIT SS A2 Noritake Super Porcelain EX-3 n COLOR FULL KIT PST Noritake Super Porcelain EX-3 NORITAKE ORIGINAL SHADE KIT Noritake Super Porcelain EX-3 FULL KIT PST SCREENING PORCELAIN Noritake Super Porcelain EX-3 Noritake Super Porcelain EX-3 TRIAL KIT UP nA2 Noritake Super Porcelain EX-3 Value Shade FULL KIT Noritake Super Porcelain EX-3 TRIAL KIT NV1120 Noritake Super Porcelain EX-3 ESTHETIC WHITE KIT Noritake Super Porcelain EX-3 n COLOR INTRO KIT Noritake Super Porcelain EX-3 n COLOR INTRO POBA KIT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EIH Powder, Porcelain Dental Class 2 872.6660 2010-03-25
EIH Powder, Porcelain Dental Class 2 872.6660 2010-03-25
EIH Powder, Porcelain Dental Class 2 872.6660 2010-03-25
EIH Powder, Porcelain Dental Class 2 872.6660 2015-03-26
EIH Powder, Porcelain Dental Class 2 872.6660 2010-03-25
EIH Powder, Porcelain Dental Class 2 872.6660 2025-06-03
EIH Powder, Porcelain Dental Class 2 872.6660 2010-03-25
EIH Powder, Porcelain Dental Class 2 872.6660 2010-03-25
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-06-05
EJQ Wheel, Polishing Agent Dental Class 1 872.6010 2010-06-17
EIH Powder, Porcelain Dental Class 2 872.6660 2022-04-20
EIH Powder, Porcelain Dental Class 2 872.6660 2010-03-25
EIH Powder, Porcelain Dental Class 2 872.6660 2010-03-25
EIH Powder, Porcelain Dental Class 2 872.6660 2012-04-16
EIH Powder, Porcelain Dental Class 2 872.6660 2017-10-18
EIH Powder, Porcelain Dental Class 2 872.6660 2010-03-25

Official Correspondent

Satoshi Yamaguchi

US Agent Details

MANABU SUZUKI Business: KURARAY AMERICA INC. Email: manabu.suzuki@kuraray.com Phone: (212) 3563940

Related Public Records

Same Entity

KURARAY NORITAKE DENTAL INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3002807420 KURARAY NORITAKE DENTAL NIIGATA PLANT TAINAI Niigata, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K143656 H.C. Starck Ceramics GmbH StarCeram® Z-Nature, StarCeram® Z-Smile 2015-07-09
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

Similar Registrations

Registration Number Establishment Name Location
3013513796 Orbray Co., Ltd. Yokote-shi Akita, JP
3034729999 LIAONING RACHCERA MATERIAL TECHNOLOGY CO.,LTD. Shenyang Liaoning, CN
3021284321 ZIRDENT NEW MATERIAL CO.,LTD Changsha Hunan, CN
3031595584 ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD Taizhou Zhejiang, CN
3030464310 DOCTUS GLOBAL Goyang-si, Gyeonggi-do, KR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614705. Last updated year: 2026. Please use registration number 9614705 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.