Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008546433

FEI Number

3008546433

Entity Name

Oral Design Center

City/State/Country

Meguro-Ku Tokyo, JP

Establishment Address

Senzoku 2-15-15, Senzoku Point 215 Building A, Meguro-Ku Tokyo 1520012, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Oral Design Boston (Owner Number: 10029109)

Owner / Operator Contact Address

11 Newbury Street, 4th floor, Boston, MA 02116, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PFM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2012-11-30

Official Correspondent

Yasuhiko Kawabe

US Agent Details

YASUHIKO KAWABE Business: ORAL DESIGN BOSTON Email: frontdesk@oraldesignboston.com Phone: (617) 2679449

Related Public Records

Same Entity

Oral Design Boston

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3004764611	MAVERICK DENTAL SOLUTIONS, LLC	Monroeville, PA, US
3013969202	FIRE DENTAL STUDIO, LLC	Westmont, IL, US
3027650644	NORTHSTAR TRADE CO., LIMITED	Mongkok KL Hong Kong, CN
3008193102	V-BEST DENTAL TECHNOLOGY LIMITED	Kwun Tong, HK
3035455236	JIYI DENTAL LABORATORY	Changhua, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008546433. Last updated year: 2026. Please use registration number 3008546433 when referencing this establishment in official correspondence.