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510(k) K800063

XR-710 by Pennwalt Corp. — Product Code EAP

K800063 is an FDA 510(k) premarket notification submitted by Pennwalt Corp. for the device "XR-710". The FDA issued a decision of Substantially Equivalent on March 3, 1980. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Pennwalt Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1980
Date Received
January 11, 1980
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 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)
  • K800133 — PANOREX II DENTAL X-RAY UNIT (March 3, 1980)
  • K780981 — PORTABLE PNEUMATIC CALIBRATOR 65-150 (August 2, 1978)

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