Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004086183

FEI Number

3004086183

Entity Name

Royal Dental Lab

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

F/1, 2, 3, 5, 6, Building 2, No. 4 West Area, Shangxue Industry Park, Bantian, Longgang, Shenzhen Guangdong 518129, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ROYAL DENTAL LABORATORY (Owner Number: 9057339)

Owner / Operator Contact Address

F/1,2,3,5,6 Building 2 NO. 4 WEST AREA SHANGXUE, INDURSTRY PARK, BANTIAN,LONGGANG, Shenzhen, CN-GD 518129, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192767

PMA Number

N/A

All Registered Proprietary Names

Dentures, full All Ceramic Restoration Restoration, resin, crown and bridge Customized Orthodontic Appliance/Device Preformed Tooth Positioner CROWN, PREFORMED Full Metal Crown/Bridge/Inlay/Onlay with Non-Precious Alloy Acrylic Partial Cast Partial Restoration, noble metal Restoration, porcelain-fused-to-metal Clear Aligner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSL	Dentures, Full	Unknown	Class N	N/A	2011-11-16
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2011-11-16
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2011-11-16
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2011-11-16
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2018-06-10
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2003-07-10
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2011-11-16
NSK	Dentures, Partial	Unknown	Class N	N/A	2011-11-16
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2011-11-16
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2011-11-16
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2020-04-16

Official Correspondent

Rachel Liao

US Agent Details

Brenda cervantes Schroeder Business: Basic Dental Implant Systems, Inc. Email: service@kaisahealth.com Phone: (505) 8811376

Related Public Records

Same Entity

ROYAL DENTAL LABORATORY

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3019909974	SHENZHEN HLD DENTAL&TECHNOLOGY CO.,LTD	Shenzhen Guangdong, CN
3030516430	DANTECH DIGITAL DENTAL SOLUTIONS PRIVATE LIMITED	Chennai Tamil Nadu, IN
3011714596	HK ADVANCED DENTAL DIGITAL LIMITED	Tsuen Wan, N.T, HK
3009093236	PERFECT CROWN DENTAL LAB	Maspeth, NY, US
3010594724	PREFERRED DENTAL LABORATORY, INC.	Roseland, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004086183. Last updated year: 2026. Please use registration number 3004086183 when referencing this establishment in official correspondence.