Home / 510(k) Clearances / K932675

510(k) K932675

GXP DENTAL X-RAY PROCESSOR by Gendex Corp. — Product Code EGN

K932675 is an FDA 510(k) premarket notification submitted by Gendex Corp. for the device "GXP DENTAL X-RAY PROCESSOR". The FDA issued a decision of Substantially Equivalent on July 26, 1993. The device falls under product code EGN (Scissors, Surgical Tissue, Dental), a Class I device regulated under 21 CFR 872.4565. Gendex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1993
Date Received
June 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors, Surgical Tissue, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Gendex Corp.

  • K952598 — GX-PAN PANORAMIC DENTAL X-RAY SYSTEM (June 29, 1995)
  • K945682 — PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL (February 9, 1995)
  • K935046 — GX-770 X-RAY CONTROL, MODEL 46-404600G4 (February 18, 1994)
  • K925094 — VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS (September 29, 1993)
  • K931001 — ORALIX DC (September 14, 1993)
  • K922165 — ATC725, ATC525, AND AP300 (July 27, 1992)
  • K920189 — GX-C CEPHALOMETER (April 28, 1992)
  • K894188 — GX-ELEVATOR (October 3, 1989)
  • K890083 — GX-2000 STATIONARY X-RAY GENERATOR (March 31, 1989)
  • K873982 — GX-MOBILE X-RAY UNIT (October 30, 1987)

Other clearances for product code EGN

  • K851720 — 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS (July 2, 1985)
  • K821276 — MAYO SCISSOR CURYED 5 1/2 (May 28, 1982)
  • K821294 — TONSIL SCISSORS STRAIGHT 5 1/2 (May 28, 1982)
  • K821275 — MAYO SCISSOR STRAIGHT 5 1/2 (May 28, 1982)
  • K821292 — TONSIL SCISSORS 7 (May 28, 1982)
  • K821077 — CONPHAR (May 24, 1982)

FDA data resources