Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013645257

FEI Number

3013645257

Entity Name

CORAL HEALTHCARE PRODUCTS MANUFACTURER CO., LTD.

City/State/Country

YANGZHOU Jiangsu, CN

Establishment Address

Room 701, Building No.18 (Creat of China), Jiang Guang Zhi Hui Cheng, No.15 East Wenchang Road, Guangling District,, YANGZHOU Jiangsu 225002, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Coral Healthcare Products Manufacturer Co., Ltd. (Owner Number: 10083948)

Owner / Operator Contact Address

Room 701, Building No.18 (Creat Of China), Jiang Guang Zhi Hui Cheng, No.15 East Wenchang Road, Yangzhou, CN-JS 225002, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DENTAL MIRROR, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: S453, DM01, AC01 DENTAL MIRROR, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: D603, D653, S451, S452 DENTAL MIRROR, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: S815, S811, S951, D600 DENTAL FLOSS, Brand: CoralClean, USOP, SKY Dental, ALLURE ORTHO, PLATYPUS, O&S DENTAL, DonnaMax Bioswiss, YS, YES STUDIO; Model: D600, D601, D603, D610, D625, D653, D656 K1, K3, K4,K6, K7, FT01, FT02, FT03, FT08, FT09, FTS451, S432, S672, S673 YS, YES STUDIO, DonnaMax, Bioswiss. Model: K1, K2, K3, K4, K5, K6, K7, K8, K9, 6200, 6201, 6202, 6203, 6204, 6205, 6206, 6207

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2022-01-03
JES	Floss, Dental	Dental	Class 1	872.6390	2022-01-03
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2023-09-14

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Coral Healthcare Products Manufacturer Co., Ltd.

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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013645257. Last updated year: 2026. Please use registration number 3013645257 when referencing this establishment in official correspondence.