Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611450

FEI Number

3002809535

Entity Name

DENTECH CORP.

City/State/Country

TOKYO, JP

Establishment Address

53 SHIMIZU-CHO, ITABASHI-KU, TOKYO 174-0053, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

DENTECH CORP. (Owner Number: 8030336)

Owner / Operator Contact Address

53 SHIMIZU-CHO, ITABASHI-KU, --, TOKYO, JP-NOTA 174-0053, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dentech Corporation MIRALAY Dentech Corporation MOUTHPIECE, SALIVA EJECTOR Dentech Corporation Dentech Corporation Dentech Corporation Dentech Corporation FORCEPS, RUBBER DAM FORCEPS, ARTICULATION PAPER FRAME, RUBBER DAM ACCESSORIES, RETRACTOR, DENTAL CLAMP, RUBBER DAM Dentech Corporation Dentech Corporation

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2016-06-08
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	1998-06-09
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2019-09-12
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	1981-08-15
EIE	Dam, Rubber	Dental	Class 1	872.6300	2019-09-12
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2019-09-12
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2019-09-12
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2019-09-12
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	1981-08-15
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	1983-09-27
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	1981-08-15
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	1998-05-21
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	1981-08-15
EAY	Light, Fiber Optic, Dental	Dental	Class 1	872.4620	2019-09-12
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2019-09-12

Official Correspondent

DAISUKE KIMURA

US Agent Details

Donna Pritchard Business: HAGER WORLDWIDE, INC. Email: d.pritchard@hagerworldwide.com Phone: (828) 6243319

Related Public Records

Same Entity

DENTECH CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
K831824	Silverman'S	DENTAL ELECTRONIC/S.B.R TRADING BU HAND	1983-08-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611450. Last updated year: 2026. Please use registration number 9611450 when referencing this establishment in official correspondence.