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Fona Stellaris 100005570

by Sirona Dental, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD7641000055701 UDI-DIDate9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Fona Stellaris
Generic Name
Dental digital imaging sensor, intraoral
Model / Reference
100005570
Primary DI / UDI-DI
D7641000055701
FDA Product Code
MQB, EHD
GMDN Term
Dental digital imaging sensor, intraoral
Device Class
Class II
Regulation Number
892.1680, 872.1800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental digital imaging sensor, intraoral

Other devices from Sirona Dental, Inc.

See all devices from Sirona Dental, Inc. →

Properties

  • Prescription Use
  • Convenience Kit
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No