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510(k) K031799

MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 by Miele, Inc. — Product Code LDS

K031799 is an FDA 510(k) premarket notification submitted by Miele, Inc. for the device "MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881". The FDA issued a decision of Substantially Equivalent on November 12, 2003. The device falls under product code LDS (Device, Pasteurization, Hot Water), a Class II device regulated under 21 CFR 880.6991.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2003
Date Received
June 10, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Pasteurization, Hot Water
Device Class
Class II
Regulation Number
880.6991
Review Panel
HO
Submission Type

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  • K983068 — RELIANCE FAMILY OF WASHER-DISINFECTORS (May 31, 2000)
  • K972193 — OLYMPIX MINI-PASTEURMATIC (58210) (September 5, 1997)
  • K950518 — MIELE G 7781 DENTAL THERMAL DISINFECTOR (January 26, 1996)
  • K950566 — DECOMAT 4656 (October 19, 1995)
  • K953645 — OLYMPIC PASTEURMATIC SYSTEM (September 22, 1995)
  • K884151 — MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. (May 16, 1989)
  • K860263 — CASTLE 7538 FLOOR LOADING WASHER (March 5, 1986)
  • K844089 — CASTLE 7515 UTENSIL/GLASSWARE WASHER (January 14, 1985)
  • K810311 — STERI-VERS (April 17, 1981)

FDA data resources