Fona Stellaris

FDA UDI

Class II (US FDA UDI)

by Sirona Dental, Inc.

Identity

Trade Name: FONA STELLARIS FDA UDI
Generic Name: Dental digital imaging sensor, intraoral FDA UDI
Device Name: FONA STELLARIS S0 SENSOR SHIP KIT, 2.7M/9FT FDA UDI
Model / Reference: 100005419 FDA UDI
Description: FONA STELLARIS S0 SENSOR SHIP KIT, 2.7M/9FT FDA UDI

Identifiers

Primary DI / UDI-DI: D7641000054191 FDA UDI
FDA Product Code: MQB FDA UDI
EHD FDA UDI
GMDN Term: Dental digital imaging sensor, intraoral FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1680 FDA UDI
872.1800 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 digital imaging sensor, intraoral

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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: Sirona Dental, Inc.

Sources (1)

FDA UDI 92406094-648f-4434-a3ef-5dcfa3b5ae21 34 fields · synced Oct 6, 2026