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510(k) K051660

DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM by Coltene/Whaledent, Inc. — Product Code KMH

K051660 is an FDA 510(k) premarket notification submitted by Coltene/Whaledent, Inc. for the device "DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM". The FDA issued a decision of Substantially Equivalent on August 4, 2005. The device falls under product code KMH (Sterilizer, Dry Heat), a Class II device regulated under 21 CFR 880.6870. Coltene/Whaledent, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2005
Date Received
June 22, 2005
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 Coltene/Whaledent, Inc.

  • K191385 — BRILLIANT COMPONEER (October 29, 2019)
  • K190597 — BRILLIANT EverGlow Flow (June 21, 2019)
  • K181500 — BRILLIANT Crios (August 15, 2018)
  • K160800 — DuoCem (November 16, 2016)
  • K152927 — BRILLIANT EVERGLOW (April 28, 2016)
  • K152243 — One Coat 7 Universal (December 9, 2015)
  • K150218 — Fill-Up! (June 23, 2015)
  • K130137 — BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER (August 23, 2013)
  • K121621 — SOLOCEM (January 8, 2013)
  • K112168 — COMPONEER (November 21, 2011)

Other clearances for product code KMH

  • K094026 — STERI-DENT, STERI-SURE (July 12, 2011)
  • 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