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510(k) K242591

XERO-alpha by DRTECH Corporation — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2024
Date Received
August 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

Other clearances by DRTECH Corporation

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  • K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXP (March 19, 2025)
  • K242847 — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (October 23, 2024)
  • K240243 — EConsole2 (September 23, 2024)
  • K233530 — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (July 26, 2024)
  • K232082 — EXPD 4343S (February 13, 2024)
  • K232753 — EXPD 4343D; EXPD 3643D (November 16, 2023)
  • K231225 — EConsole1 (October 18, 2023)
  • K230871 — EXTRON 5; EXTRON 7 (August 17, 2023)

Other clearances for product code EHD

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  • K251438 — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (September 4, 2025)
  • K242185 — Rextar Pro (December 4, 2024)
  • K241963 — WERAY (July 30, 2024)
  • K241305 — LifeRay Intraoral Handheld X-ray System (July 5, 2024)
  • K240759 — REMEX-GR100 (May 13, 2024)
  • K233914 — XVbeam2000 (February 8, 2024)
  • K233395 — Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) (January 3, 2024)