Home / 510(k) Clearances / K040748

510(k) K040748

ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM by Takara Belmont USA, Inc. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2004
Date Received
March 23, 2004
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 Takara Belmont USA, Inc.

  • K102456 — INTRAORAL BELSENSOR GOLD (December 15, 2011)
  • K072273 — BELMONT QUOLIS 5000 SERIES DENTAL UNIT (December 20, 2007)
  • K062529 — BELMAX CM MODEL X168 (October 5, 2006)
  • K041834 — ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, (December 3, 2004)
  • K042260 — PHOT-X II, MODEL 303 (September 7, 2004)

Other clearances for product code EHD

  • 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)
  • K233914 — XVbeam2000 (February 8, 2024)