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XERO-alpha XERO α

by Drtech Corp.

XERO-alpha XERO α is a Class II device made by Drtech Corp., cleared under FDA 510(k) K242591 on 1 Nov 2024 and listed in FDA GUDID since 17 Mar 2026 (UDI-DI 08800018424704), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K242591

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800018424704 UDI-DI Date17 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK242591 Date1 Nov 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242591 decided 1 Nov 2024 Active
  • FDA GUDID UDI-DI 08800018424704 listed 17 Mar 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K242591
  2. Listed FDA GUDID 08800018424704

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
XERO-alpha
Generic name
Hand-held intraoral dental x-ray system, digital
Model / reference
XERO α
Primary DI / UDI-DI
08800018424704
510(k) Number
FDA product code
EHD
GMDN term
Hand-held intraoral dental x-ray system, digital
Device class
Class II
Regulation number
872.1800
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code EHD (Unit, X-Ray, Extraoral With Timer).

Other devices from Drtech Corp.

See all devices from Drtech Corp. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)