Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2916735

FEI Number

2916735

Entity Name

SHOFU DENTAL CORP.

City/State/Country

SAN MARCOS, CA, US

Establishment Address

1225 Stone Dr, SAN MARCOS, CA 92078, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SHOFU INC. (Owner Number: 9056340)

Owner / Operator Contact Address

11 KAMITAKAMATSU-CHO, FUKUINE, HIGASHIYAMA-KU, KYOTO, JP-26 605-0983, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180649

PMA Number

N/A

All Registered Proprietary Names

LAYZIR DISC BEAUTIBOND UNIVERSAL SUPER-SNAP POLYSTRIPS SUPER-SNAP IPR VINTAGE LD BEAUTIBOND XTREME THE ARTISTIC COMPOSITE KIT ROBOT CARBIDE BEAUTIBOND INCISAL EDGE WEAR KIT UNIVERSAL OPAQUE SHOFU ENAMEL CONDITIONER VINTAGE PRO BEAUTILINK SA DENTADISC BEAUTIFIL II LS SUPER-SNAP VINTAGE ART UNIVERSAL ZIRCONOMER P GLASIONOMER FX-LC MONOCEM BeautiSealant Needle Tips 23G MICD INSTRUMENTS BEAUTIFIL Needle Tips 18G BEAUTIFIL Needle Tips 20G-L BeautiSealant Needle Tips 27G BEAUTIFIL Needle Tips 20G DENTALAZE EYECAM GLASIONOMER FX ULTRA BEAUTIFIL II Enamel Beautifil II Gingiva PINK & Enamel WHITE Kit SHOFU MZ Primer Plus VINTAGE PRIME PRESS THE ATTACHMENT REMOVAL KIT FOR CLEAR ALIGNERS ZILMASTER BURBUTLER ALL CERAMIC ABRASIVE KIT BURBUTLER CADMASTER KIT DURAGREEN FINE ONE GLOSS ACRYPOINT DURAWHITE ACRYLIC KIT HP COREMASTER LAB CORAL DURA-GREEN FINE CERAMASTER DURA-GREEN STONES CERAMISTE AMALGAM & ALLOY POLISHING KIT CA LAB PINK SUPERGREENIE ZIRCONIA POLISHING KIT CA COMPOSITE POLISHING KIT CA DURAGREEN AMALGAM & ALLOY POLISHING KIT FG ACRYLIC POLISHING KIT HP COMPOSITE PORCELAIN & ENAMEL POLISHING KIT CA SUPERSNAP SUPERBUFF COMPOMASTER CERAMISTE SOFT GREENIE HARDIE COMPOSITE KIT CA ONE GLOSS PS SAMPLE PACK ZIRCONIA KIT CA LAB WHITE BROWNIE AMALGAM & METALS KIT CA PORCELAIN & ENAMEL KIT CA AMALGAM & METALS KIT FG SUPER SNAP X-TREME SAMPLE PACK AMALGAM & METALS POLISHING KIT FG DURA-WHITE STONES SUPER-SNAP AMALGAM & METALS POLISHING KIT CA PINK PREPARATION BUT ACRYLIC POLISHING KIT SUPER-SNAP SUPERBUFF PORCELAIN BRUSH ART PORCELAIN BRUSH SET ART PORCELAIN BRUSH ART SET UNI BRUSH VINTAGE ART LF BEAUTICEM VENEER KIT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-09-23
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2018-12-19
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2021-12-02
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-01-15
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2023-01-10
EJL	Bur, Dental	Dental	Class 1	872.3240	1996-01-02
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-12-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2015-02-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-02-03
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2018-12-19
EMA	Cement, Dental	Dental	Class 2	872.3275	2023-10-17
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2026-01-23
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2026-01-23
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2026-01-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-02-03
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	1978-06-05
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2019-10-17
EMA	Cement, Dental	Dental	Class 2	872.3275	2026-01-27
EMA	Cement, Dental	Dental	Class 2	872.3275	2026-01-27
EMA	Cement, Dental	Dental	Class 2	872.3275	2018-08-15
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2015-11-05
NVK	Laser, Dental, Soft Tissue	General, Plastic Surgery	Class 2	878.4810	2023-05-11
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-05-11
QJK	Intraoral Camera	Dental	Class 2	872.3661	2020-07-10
EMA	Cement, Dental	Dental	Class 2	872.3275	2026-01-27
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2016-01-11
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2017-09-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2017-09-11
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-04-02
EHL	Point, Abrasive	Dental	Class 1	872.6010	2003-10-06
KXR	Applicator, Resin	Dental	Class 1	872.3140	2022-09-26
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-01-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-06-13
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2019-06-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SHOFU 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
3013526557	SHOFU PRODUCTS KYOTO INC.	Kyoto, JP
3006942526	SHANGHAI SHOFU DENTAL MATERIAL CO. LTD	Shanghai, CN
3011814610	SHIGA SHOFU INC.	Koka Shiga, JP
3031601673	SHOFU PRODUCTS VIETNAM CO., LTD	Dong Van Ward Ninh Binh, VN
3002808149	SHOFU INC.	FUKUINE, HIGASHIYAMA-KU Kyoto, 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
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2916735. Last updated year: 2026. Please use registration number 2916735 when referencing this establishment in official correspondence.