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510(k) K941349

DENTAL TRAY by Cush Medical Products — Product Code EIA

K941349 is an FDA 510(k) premarket notification submitted by Cush Medical Products for the device "DENTAL TRAY". The FDA issued a decision of SN on July 26, 1994. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Cush Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
July 26, 1994
Date Received
March 21, 1994
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 Cush Medical Products

  • K943424 — CUSH ISLAND DRESSING (October 3, 1994)
  • K940518 — C-SECTION TRAY (August 18, 1994)
  • K941645 — BIOPSY TRAY (July 14, 1994)
  • K940239 — EYE TRAY (June 28, 1994)
  • K935684 — IV START KIT (June 10, 1994)
  • K941455 — STERILE GAUZE PRODUCT LINE (May 20, 1994)
  • K941522 — STERILE X-RAY DETECTABLE GAUZE SPONGES (May 12, 1994)
  • K941344 — LAP SPONGE PRODUCT LINE (May 12, 1994)
  • K935697 — CIRCUMCISION TRAY (May 2, 1994)
  • K936120 — LABOR AND DELIVERY TRAY (March 30, 1994)

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