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510(k) K913464

STOMAVISION (STV) by Trophy Radiologie — Product Code EIA

K913464 is an FDA 510(k) premarket notification submitted by Trophy Radiologie for the device "STOMAVISION (STV)". The FDA issued a decision of Substantially Equivalent on November 13, 1991. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Trophy Radiologie has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1991
Date Received
August 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Other clearances by Trophy Radiologie

  • K033690 — TROPHYPAN AND TROPHYPAN C (February 20, 2004)
  • K033419 — STV PRO 2 (February 2, 2004)
  • K023346 — TROPHYPAN (January 3, 2003)
  • K012514 — DIGIPAN / DPI (December 21, 2001)
  • K991455 — ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMI (June 25, 1999)
  • K991912 — MODIFICATION TO DIGIPAN (June 22, 1999)
  • K961826 — DIGIPAN (September 23, 1996)
  • K962337 — ELITYS OR ELITYS-E (July 25, 1996)
  • K953936 — ATLANTIS (December 28, 1995)
  • K951074 — STOMAVISION (STV) (September 19, 1995)

Other clearances for product code EIA

  • K251626 — Midmark Dental Delivery System (November 3, 2025)
  • K251491 — K5 Cart, K5 Mount, K5 Swing (July 17, 2025)
  • K243130 — Integral Dental Unit (June 27, 2025)
  • K242611 — Integral Dental Units (May 27, 2025)
  • K250473 — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus (February 19, 2025)
  • K242404 — BDC Dental Unit (February 7, 2025)
  • K231297 — Firstar Dental Unit (January 27, 2025)
  • K233805 — K5 (September 3, 2024)
  • K240754 — N2 (March 21, 2024)
  • K231845 — Dental unit Model: Mare (February 28, 2024)

FDA data resources