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ZMD-1000B Model

FDA UDI

Class I (US FDA UDI)

by Dentis Co. , Ltd

Identity

Trade Name
ZMD-1000B Model FDA UDI
Generic Name
Tactile orientation material FDA UDI
Device Name
Dental Model Resin / ZMD-1000B Model FDA UDI
Model / Reference
ZMD-1000B Model FDA UDI
Description
Dental Model Resin / ZMD-1000B Model FDA UDI

Identifiers

Primary DI / UDI-DI
08800053015035 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Tactile orientation 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: Tactile orientation material

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

Similar devices

Also classified as Tactile orientation 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 19c8aa5f-19a0-4254-96f1-06d1981b84c8 33 fields · synced May 30, 2026