Cara

FDA UDI

Class II (US FDA UDI)

by Kulzer, Inc.

Identity

Trade Name: Cara FDA UDI
Generic Name: Dental milling system, CAD/CAM, laboratory FDA UDI
Device Name: Cara i500 Replacement Unit FDA UDI
Model / Reference: 66088938 FDA UDI
Description: Cara i500 Replacement Unit FDA UDI

Identifiers

Catalog Number: 66088938 FDA UDI
Primary DI / UDI-DI: J014660889381 FDA UDI
FDA Product Code: NOF FDA UDI
GMDN Term: Dental milling system, CAD/CAM, laboratory FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3661 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental milling system, CAD/CAM, laboratory

Cara by Kulzer, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Kulzer, Inc.

Sources (1)

FDA UDI 5bc46405-ba4d-4ba4-9a6e-efad05116cd2 35 fields · synced Jun 6, 2026