Primescan 2 Multiuse Sleeve

FDA UDIEUDAMED

Class II (US FDA UDI)

by Sirona Dental Systems GmbH

Identity

Trade Name: Primescan 2 Multiuse Sleeve FDA UDI
Generic Name: Intraoral optical scanning system FDA UDI
Device Name: Primescan 2 Multiuse Sleeve FDA UDI
Model / Reference: 6805365 FDA UDI
Description: Primescan 2 Multiuse Sleeve FDA UDI

Identifiers

Catalog Number: 6805365 FDA UDI
Primary DI / UDI-DI: E27668053651 FDA UDI
FDA Product Code: NBL FDA UDI
NOF FDA UDI
NTK FDA UDI
GMDN Term: Intraoral optical scanning system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.1745 FDA UDI
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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Intraoral optical scanning system

Primescan 2 Multiuse Sleeve by Sirona Dental Systems GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Also classified as Intraoral optical scanning system.

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COMFORT+ — D.D.S., Inc. · Class II
PANDA SCANNER — Ziyang Freqty Medical Equipment Co., Ltd. · Class II
INTELLISCAN 3D® Intraoral Scanner — Shining 3D Tech Co., Ltd. · Class II
SHINING 3D® Intraoral Scanner — Shining 3D Tech Co., Ltd. · Class II
Ori — ORI INC · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Sirona Dental Systems GmbH

Sources (2)

FDA UDI bd698917-f548-4118-83f1-99519fdcdb7f 35 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 4, 2026