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510(k) K960819

HELIODENT DS by Pelton & Crane Co. — Product Code EAP

K960819 is an FDA 510(k) premarket notification submitted by Pelton & Crane Co. for the device "HELIODENT DS". The FDA issued a decision of Substantially Equivalent on March 29, 1996. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Pelton & Crane Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1996
Date Received
February 29, 1996
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 Pelton & Crane Co.

  • K171872 — P50 Series Dental Operative Unit and Accessories (April 26, 2018)
  • K143696 — Spirit (September 18, 2015)
  • K972249 — ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD (September 12, 1997)
  • K972168 — SIDEXIS DIGITAL RADIOGRAPHY SYSTEM (September 5, 1997)
  • K945117 — DELTA (February 28, 1997)
  • K962071 — SPIRIT S1/S2 (August 6, 1996)
  • K950299 — CEREC 2 (May 23, 1995)
  • K946187 — SPIRIT II AND SPIRIT TREATMENT CENTER (March 1, 1995)
  • K950030 — HELIODENT MD (February 3, 1995)
  • K936068 — ORTHOPHOS 3/ ORTHOPHOS 3C (July 29, 1994)

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)
  • 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)
  • K951734 — LUMIX 70B (July 20, 1995)

FDA data resources