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510(k) K094026

STERI-DENT, STERI-SURE by Cpac, Inc. — Product Code KMH

K094026 is an FDA 510(k) premarket notification submitted by Cpac, Inc. for the device "STERI-DENT, STERI-SURE". The FDA issued a decision of Substantially Equivalent on July 12, 2011. The device falls under product code KMH (Sterilizer, Dry Heat), a Class II device regulated under 21 CFR 880.6870. Cpac, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2011
Date Received
December 30, 2009
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 Cpac, Inc.

  • K110867 — STERI-DENT, STERI-SURE (July 20, 2011)
  • K781486 — STERI-VAC POWER UNITS (September 27, 1978)
  • K771070 — DRY HEAT STERILIZER (July 14, 1977)
  • K771071 — PORTO-VAC (July 14, 1977)

Other clearances for product code KMH

  • 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)
  • K880322 — DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM (July 13, 1988)
  • 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