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510(k) K910202

DENTRONIX MODEL 2000 by Dentronix, Inc. — Product Code KMH

K910202 is an FDA 510(k) premarket notification submitted by Dentronix, Inc. for the device "DENTRONIX MODEL 2000". The FDA issued a decision of Substantially Equivalent on Mar 13, 1991. The device falls under product code KMH (Sterilizer, Dry Heat), a Class II device regulated under 21 CFR 880.6870. Dentronix, Inc. has 8 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 13, 1991
Date Received
Jan 10, 1991
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
510(k)

Other clearances by Dentronix, Inc.

  • K880322 — DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM (Jul 13, 1988)
  • K771005 — NEW PODIATRY PRODUCTS (Jun 17, 1977)
  • K771006 — MODIFIED PODIATRY PRODUCTS (Jun 17, 1977)
  • K770302 — CUTTER, P606 BONE (Mar 9, 1977)
  • K770305 — CUTTER, P607 BONE (Mar 9, 1977)
  • K770304 — CUTTER, P605 GENERAL PURPOSE (Mar 9, 1977)
  • K770303 — NIPPER, NAIL, P610 ENGLISH (Mar 9, 1977)
  • K770301 — NIPPER, PSO4 TISSUE (Mar 7, 1977)

Other clearances for product code KMH

  • K094026 — STERI-DENT, STERI-SURE (Jul 12, 2011)
  • K051660 — DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM (Aug 4, 2005)
  • K910925 — DISINFECTION WITH THE COX DRY HEAT STERILIZER (May 8, 1992)
  • K880322 — DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM (Jul 13, 1988)
  • K881371 — COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE (Apr 13, 1988)
  • K872643 — COX RAPID HEAT TRANSFER STERILIZER (Oct 29, 1987)
  • K871615 — U. V. GERMICIDAL UNIT (Sep 11, 1987)
  • K851307 — INOX DRY HEAT STERILIZER (May 9, 1985)
  • K771070 — DRY HEAT STERILIZER (Jul 14, 1977)

FDA data resources

Source: FDA 510(k) database entry for K910202. Report a data issue: hello@regdatalab.com.