Cdr Elite

FDA UDI

Class II (US FDA UDI)

by Sirona Dental, Inc.

Identity

Trade Name: CDR ELITE FDA UDI
Generic Name: Dental digital imaging sensor, intraoral FDA UDI
Device Name: CDR ELITE SENSOR S2 FDA UDI
Model / Reference: B1207200 FDA UDI
Description: CDR ELITE SENSOR S2 FDA UDI

Identifiers

Primary DI / UDI-DI: D764B12072000 FDA UDI
510(k) Number: K072134 FDA UDI
FDA Product Code: MUH FDA UDI
MQB FDA UDI
EHD FDA UDI
GMDN Term: Dental digital imaging sensor, intraoral FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.1800 FDA UDI
892.1680 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental digital imaging sensor, intraoral

Cdr Elite by Sirona Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental digital imaging sensor, intraoral.

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Schick — Dentsply International · Class II
BMS DENTAL — NEW LIFE RADIOLOGY Srl · Class IIb
Midmark OptiMax Digital Sensor System — Midmark Corporation · Class II
Beyes — Beyes Dental Canada Inc · Class II
Midmark OptiMax Digital Sensor System — Midmark Corporation · Class II

Cleared under the same submission

K072134 also covers:

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, Inc.

Sources (1)

FDA UDI 141e57cb-a2f4-4591-ab0b-eca155f4d20f 35 fields · synced May 30, 2026