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Ortek Therapeutics, Inc. Ortek-ECD

by Ortek Therapeutics, Inc.

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 Number00858197004062 UDI-DI Date21 Dec 2022ListedStatusListed 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  • Withdrawn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
Ortek Therapeutics, Inc.
Generic Name
Dental caries detector, electrical impedance
Model / Reference
Ortek-ECD
Primary DI / UDI-DI
00858197004062
510(k) Number
FDA Product Code
NBL, LFC
GMDN Term
Dental caries detector, electrical impedance
Device Class
Class II
Regulation Number
872.1745, 872.1740
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental caries detector, electrical impedance

Other devices from Ortek Therapeutics, Inc.

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No