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510(k) K936068

ORTHOPHOS 3/ ORTHOPHOS 3C by Pelton & Crane Co. — Product Code EAP

K936068 is an FDA 510(k) premarket notification submitted by Pelton & Crane Co. for the device "ORTHOPHOS 3/ ORTHOPHOS 3C". The FDA issued a decision of Substantially Equivalent on July 29, 1994. 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
July 29, 1994
Date Received
December 21, 1993
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)
  • K960819 — HELIODENT DS (March 29, 1996)
  • K950299 — CEREC 2 (May 23, 1995)
  • K946187 — SPIRIT II AND SPIRIT TREATMENT CENTER (March 1, 1995)
  • K950030 — HELIODENT MD (February 3, 1995)

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