Cerec Sw

FDA UDI

Class II (US FDA UDI)

by Sirona Dental Systems GmbH

Identity

Trade Name: CEREC SW FDA UDI
Generic Name: CAD/CAM software FDA UDI
Device Name: CEREC Premium CAM SW 4.4.0 FDA UDI
Model / Reference: 6574250 FDA UDI
Description: CEREC Premium CAM SW 4.4.0 FDA UDI

Identifiers

Primary DI / UDI-DI: E27665742500 FDA UDI
510(k) Number: K100152 FDA UDI
K111421 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: CAD/CAM software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: CAD/CAM software

Cerec Sw by Sirona Dental Systems GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Sirona Dental Systems GmbH

Sources (1)

FDA UDI 1248b987-40cf-4e20-9286-746b2088ca53 35 fields · synced May 30, 2026