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ZMD-1000B Castable

FDA UDI

Class I (US FDA UDI)

by Dentis Co. , Ltd

Identity

Trade Name
ZMD-1000B Castable FDA UDI
Generic Name
Patient positioning thermoplastic mould material FDA UDI
Device Name
ZMD-1000B Castable FDA UDI
Model / Reference
ZMD-1000B Castable FDA UDI
Description
ZMD-1000B Castable FDA UDI

Identifiers

Primary DI / UDI-DI
08800053014212 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Patient positioning thermoplastic mould material FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 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

Yes

FDA UDI

Over-the-Counter

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Patient positioning thermoplastic mould material

ZMD-1000B Castable by Dentis Co. , Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient positioning thermoplastic mould material.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentis Co. , Ltd

Sources (1)

  • FDA UDI c5339c03-95a7-4cde-b39c-c7b1de2d02ee 33 fields · synced May 30, 2026