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510(k) K792307

DENTIX DENTAL X-RAY UNIT by Precise Optics — Product Code EAP

K792307 is an FDA 510(k) premarket notification submitted by Precise Optics for the device "DENTIX DENTAL X-RAY UNIT". The FDA issued a decision of Substantially Equivalent on January 9, 1980. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Precise Optics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1980
Date Received
November 16, 1979
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 Precise Optics

  • K030061 — PS 3000 DIGATAL PHOTOSPOT SYSTEM (April 7, 2003)
  • K935580 — PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER (March 16, 1994)
  • K932878 — PRECISION INTRA-ORAL SCOPES (January 6, 1994)
  • K914084 — ENDOSCOPES (January 22, 1992)
  • K914184 — P2020-8-0 BEAM-LIMITING DEVICE (November 27, 1991)
  • K911744 — PRECISION OPTICS CORPORATION LAPAROSCOPE (July 26, 1991)
  • K903459 — PRECISION OPTICS ENDOSCOPE ADAPTER (October 26, 1990)
  • K903458 — PRECISION OPTICS IMAGE COUPLER (October 19, 1990)
  • K903457 — PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) (October 19, 1990)
  • K827087 — P1808 MOBILE C-ARM IMAGE INTENSIFIER (March 4, 1982)

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