Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009312656

FEI Number

3009312656

Entity Name

MONDE DENTAL LAB

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

4Floor,Biguiyuan 28 Cang, Xixiang, BaoAn, Shenzhen Guangdong 518102, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Monde Dental Lab (Owner Number: 10037856)

Owner / Operator Contact Address

Rm C, 29th Block, 5F, Yintian Industrial Area, Xixiang, BaoAn, Shenzhen, CN-GD 518102, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090434

PMA Number

N/A

All Registered Proprietary Names

Mon Crown Porcelain crown M crown

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	2011-08-24
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2012-02-21
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2013-08-27

Official Correspondent

Jack Mott

US Agent Details

Yao Zheng Business: Monde Dental Lab Email: service@mondedentallab.com Phone: (610) 7388866

Related Public Records

Same Entity

Monde Dental Lab

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
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09

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
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
3008546433	Oral Design Center	Meguro-Ku Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009312656. Last updated year: 2026. Please use registration number 3009312656 when referencing this establishment in official correspondence.