Primescan 2 6835610

by SIRONA Dental Systems GmbH

Primescan 2 6835610 is a Class II device made by SIRONA Dental Systems GmbH, listed in FDA GUDID since 24 Jul 2024 (UDI-DI E27668356100), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberE27668356100 UDI-DI	Date24 Jul 2024Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Primescan 2
Generic name: Intraoral optical scanning system
Model / Ref / Catalog: 6835610

Primary DI / UDI-DI: E27668356100
FDA product code: NOF
GMDN term: Intraoral optical scanning system

Device class: Class II
Regulation number: 872.3661
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Premarket exempt
Serial number

Other properties (12, all answered No)