Clinician Kit

FDA UDI

Class I (US FDA UDI)

by Sirona Dental Systems GmbH

Identity

Trade Name: Clinician Kit FDA UDI
Generic Name: Dental milling system, CAD/CAM, chairside FDA UDI
Device Name: Primescan Connect OEM Clinician Kit FDA UDI
Model / Reference: 6828375 FDA UDI
Description: Primescan Connect OEM Clinician Kit FDA UDI

Identifiers

Catalog Number: 6828375 FDA UDI
Primary DI / UDI-DI: E27668283750 FDA UDI
FDA Product Code: NDP FDA UDI
PNP FDA UDI
NHA FDA UDI
GMDN Term: Dental milling system, CAD/CAM, chairside FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
872.3630 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental milling system, CAD/CAM, chairside

Clinician Kit by Sirona Dental Systems GmbH — 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: Sirona Dental Systems GmbH

Sources (1)

FDA UDI 56b5ae8d-0600-40c0-8b5f-b29e95c33b6a 35 fields · synced May 30, 2026