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Molekur One

FDA UDI

Class I (US FDA UDI)

by Shanghai Coherz Technology Co., Ltd.

Identity

Trade Name
Molekur One FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
10pcs/bag FDA UDI
Model / Reference
One-Disc-0.76-125 FDA UDI
Description
10pcs/bag FDA UDI

Identifiers

Primary DI / UDI-DI
06975527183069 FDA UDI
FDA Product Code
DYJ FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5410 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, thermoplastic

Molekur One by Shanghai Coherz Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shanghai Coherz Technology Co., Ltd.

Sources (1)

  • FDA UDI fcbe191a-f22b-4eca-b661-17bd522843fd 33 fields · synced Jun 8, 2026