Skip to content

Galileos Family

by SIRONA Dental Systems GmbH 510(k)

Active United States

510(k) K123070

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123070 Date15 Mar 2013ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
OAS
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from SIRONA Dental Systems GmbH

See all devices from SIRONA Dental Systems GmbH →