Zrcoop

FDA UDI

Class II (US FDA UDI)

by Hangzhou Thales Medtech Co., Ltd.

Identity

Trade Name: Zrcoop FDA UDI
Generic Name: Complete upper denture FDA UDI
Device Name: Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics. The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown,Bridge,Veneer,Inlay) that will be cemented to a natural or artificial tooth abutment. FDA UDI
Model / Reference: Additive manufacturing of zirconia porcelain crowns and bridges FDA UDI
Description: Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics. The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown,Bridge,Veneer,Inlay) that will be cemented to a natural or artificial tooth abutment. FDA UDI

Identifiers

Primary DI / UDI-DI: 06975409640055 FDA UDI
510(k) Number: K240586 FDA UDI
FDA Product Code: ELL FDA UDI
EIH FDA UDI
GMDN Term: Complete upper denture FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3920 FDA UDI
872.6660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Complete upper denture

Zrcoop by Hangzhou Thales Medtech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Complete upper denture.

Flexcera™ Smile Ultra+ Bleach — Envisiontec GmbH · Class II
Denture, Restoration — ACESO DENTAL LABORATORY COMPANY LIMITED · N
Cast Full Denture Co Cr — Beijing Yingguan Dental Technology Co., Ltd. · N
Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
Denture, retoration — Modern Dental Laboratory (DG) Co., Ltd. · N
Denture, Restoration — ACESO DENTAL LABORATORY COMPANY LIMITED · N
Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N

Cleared under the same submission

K240586 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Hangzhou Thales Medtech Co., Ltd.

Sources (1)

FDA UDI d5650c2b-2efb-42c3-9dde-a5eb83160b1d 35 fields · synced May 30, 2026