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510(k) K861328

NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY by Belmont Equipment Corp. — Product Code EAP

K861328 is an FDA 510(k) premarket notification submitted by Belmont Equipment Corp. for the device "NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY". The FDA issued a decision of Substantially Equivalent on April 24, 1986. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Belmont Equipment Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1986
Date Received
April 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Intraoral
Device Class
Class II
Regulation Number
872.1810
Review Panel
RA
Submission Type

Other clearances by Belmont Equipment Corp.

  • K000799 — BELMONT UNIT, MODEL 2000 SERIES (May 17, 2000)
  • K983661 — BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES (January 12, 1999)
  • K963699 — BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY (December 23, 1996)
  • K900681 — PANORAMIC MODEL X-CALIBER X-RAY (May 23, 1990)
  • K874238 — MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY (December 7, 1987)
  • K870300 — BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75 (March 25, 1987)
  • K852019 — BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD (June 5, 1985)
  • K844554 — BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG (February 21, 1985)
  • K834279 — ACURAY 071A DENTAL INTRAORAL X-RAY (December 29, 1983)
  • K832065 — ACURACY 071, DENTAL, INTRAORAL-X-RAY (September 12, 1983)

Other clearances for product code EAP

  • K113360 — MEDICAL IMAGE PROCESSING UNIT (February 7, 2012)
  • K102573 — PROVU (TM) DENTAL X-RAY SYSTEM (June 30, 2011)
  • K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (November 30, 2009)
  • K080738 — DENTRON SENSOR (May 13, 2008)
  • K052422 — THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) (September 27, 2005)
  • K041385 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (June 7, 2004)
  • K960819 — HELIODENT DS (March 29, 1996)
  • K960028 — ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM (March 1, 1996)
  • K953936 — ATLANTIS (December 28, 1995)
  • K954565 — EXPLOR-X (AZTEH) HF (October 27, 1995)

FDA data resources