Zmd-1000b Tray

FDA UDI

Class I (US FDA UDI)

by Dentis Co. , Ltd

Identity

Trade Name: ZMD-1000B TRAY FDA UDI
Generic Name: Dental impression tray material FDA UDI
Device Name: Impression Tray Resin / ZMD-1000B TRAY FDA UDI
Model / Reference: ZMD-1000B TRAY FDA UDI
Description: Impression Tray Resin / ZMD-1000B TRAY FDA UDI

Identifiers

Primary DI / UDI-DI: 08800053007344 FDA UDI
FDA Product Code: EBH FDA UDI
GMDN Term: Dental impression tray material FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3670 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental impression tray material

Zmd-1000b Tray by Dentis Co. , Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Dentis Co. , Ltd

Sources (1)

FDA UDI 1a23f65b-2031-450d-81bc-52ad628bd524 33 fields · synced Jun 6, 2026