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Solo 10-001

by Jazz Imaging, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00867359000309 UDI-DI Date30 Jul 2019ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Solo
Generic Name
Dental digital imaging sensor, intraoral
Model / Ref / Catalog
10-001, 10-002
Primary DI / UDI-DI
00867359000309
510(k) Number
FDA Product Code
MUH
GMDN Term
Dental digital imaging sensor, intraoral
Device Class
Class II
Regulation Number
872.1800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental digital imaging sensor, intraoral

Other devices from Jazz Imaging, LLC

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