Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016117382

FEI Number

3016117382

Entity Name

VIVI DENTAL LABORATORY

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

4F, Building D, Hui Xin Ind Park, Yong He Rd, Fu Hai, Fu Yong, Baoan, Shenzhen Guangdong 518103, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

VIVI Dental Laboratory (Owner Number: 10062061)

Owner / Operator Contact Address

4F, Building D, Hui Xin Ind Park, Yong He Rd, Fu Hai, Fu Yong, Baoan, Shenzhen, CN-GD 518103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Denture, Plastic, Teeth Co/Cr Partial Denture, Acrylic Denture Attachment, Precision, All Dental Plaster Model, Co/Cr Partial Framework Restoration, Resin, Crown And Bridge Dental Crown, PFM Crown, Full Metal Crown, Implant Crown, Acrylic Denture Dentures, Full

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2019-12-14
NSK	Dentures, Partial	Unknown	Class N	N/A	2019-12-14
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2019-12-14
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2019-12-14
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2019-12-14
NSL	Dentures, Full	Unknown	Class N	N/A	2019-12-14

Official Correspondent

Bibo Yi

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

VIVI Dental Laboratory

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
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

Similar Registrations

Registration Number	Establishment Name	Location
3016564992	DENTAC LLC	North Miami, FL, US
3042623520	ZINGO DIGITAL DENTAL LAB LLC	Mount Prospect, IL, US
3010253209	ENTA B.V.	Bergen op Zoom Noord-Brabant, NL
3007740664	Shenzhen Jiahong Dental Technology Co., Ltd	Shenzhen Guangdong, CN
3002727993	GEBDI DENTAL PRODUCTS GMBH	Engen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016117382. Last updated year: 2026. Please use registration number 3016117382 when referencing this establishment in official correspondence.