Home / 510(k) Clearances / K880322

510(k) K880322

DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM by Dentronix, Inc. — Product Code KMH

K880322 is an FDA 510(k) premarket notification submitted by Dentronix, Inc. for the device "DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 13, 1988. The device falls under product code KMH (Sterilizer, Dry Heat), a Class II device regulated under 21 CFR 880.6870. Dentronix, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1988
Date Received
January 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Dry Heat
Device Class
Class II
Regulation Number
880.6870
Review Panel
HO
Submission Type

Other clearances by Dentronix, Inc.

  • K910202 — DENTRONIX MODEL 2000 (March 13, 1991)
  • K771005 — NEW PODIATRY PRODUCTS (June 17, 1977)
  • K771006 — MODIFIED PODIATRY PRODUCTS (June 17, 1977)
  • K770304 — CUTTER, P605 GENERAL PURPOSE (March 9, 1977)
  • K770302 — CUTTER, P606 BONE (March 9, 1977)
  • K770303 — NIPPER, NAIL, P610 ENGLISH (March 9, 1977)
  • K770305 — CUTTER, P607 BONE (March 9, 1977)
  • K770301 — NIPPER, PSO4 TISSUE (March 7, 1977)

Other clearances for product code KMH

  • K094026 — STERI-DENT, STERI-SURE (July 12, 2011)
  • K051660 — DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM (August 4, 2005)
  • K910925 — DISINFECTION WITH THE COX DRY HEAT STERILIZER (May 8, 1992)
  • K910202 — DENTRONIX MODEL 2000 (March 13, 1991)
  • K881371 — COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE (April 13, 1988)
  • K872643 — COX RAPID HEAT TRANSFER STERILIZER (October 29, 1987)
  • K871615 — U. V. GERMICIDAL UNIT (September 11, 1987)
  • K851307 — INOX DRY HEAT STERILIZER (May 9, 1985)
  • K771070 — DRY HEAT STERILIZER (July 14, 1977)

FDA data resources