XERO-alpha— 510(k) K242591

Substantially Equivalent

DRTECH Corporation

FDA 510(k) clearance K242591 for XERO-alpha, Substantially Equivalent on 2024-11-01. Applicant: DRTECH Corporation. Device class: 2.

Clearance details

Applicant: DRTECH Corporation
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2024-08-30
Decision date: 2024-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jungwon-Gu, Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EHD

K260367 — Portable Dental X-ray System Model PDX nova2026-05-27
K253864 — NOMAD Pro 32026-03-20
K252110 — Dental X-RAY Unit (AJX200)2026-03-12
K254018 — Portable Dental X-ray Device (GT-1)2026-02-19
K252909 — Diagnostic X-Ray Equipment Model POCT222026-02-03

More clearances from DRTECH Corporation

K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H2026-09-08
K261413 — EXTRON 3; EXTRON 62026-08-19
K250010 — EXTRON 3; EXTRON 5; EXTRON 72025-06-10
K242770 — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG2025-03-20
K243443 — EXPD 4343N1 +9 more2025-03-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.