Home / 510(k) Clearances / K800133

510(k) K800133

PANOREX II DENTAL X-RAY UNIT by Pennwalt Corp. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1980
Date Received
January 21, 1980
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 Pennwalt Corp.

  • K833241 — INTREX (October 28, 1983)
  • K801860 — S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX (October 10, 1980)
  • K801274 — S.S. WHITE-PENNWALT PRELUDE PIT SEALANT (June 9, 1980)
  • K800063 — XR-710 (March 3, 1980)
  • K780981 — PORTABLE PNEUMATIC CALIBRATOR 65-150 (August 2, 1978)

Other clearances for product code EHD

  • K253864 — NOMAD Pro 3 (March 20, 2026)
  • K252110 — Dental X-RAY Unit (AJX200) (March 12, 2026)
  • K254018 — Portable Dental X-ray Device (GT-1) (February 19, 2026)
  • K252909 — Diagnostic X-Ray Equipment Model POCT22 (February 3, 2026)
  • K251438 — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (September 4, 2025)
  • K242185 — Rextar Pro (December 4, 2024)
  • K242591 — XERO-alpha (November 1, 2024)
  • K241963 — WERAY (July 30, 2024)
  • K241305 — LifeRay Intraoral Handheld X-ray System (July 5, 2024)
  • K240759 — REMEX-GR100 (May 13, 2024)