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510(k) K022816

W & H LISA STEAM STERILIZER by A-Dec, Inc. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2003
Date Received
August 26, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

Other clearances by A-Dec, Inc.

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  • K133776 — A-DEC/W&H ELECTRIC HANDPIECE MOTOR (May 28, 2014)
  • K102234 — A-DEC 200 DENTAL SYSTEM (November 24, 2010)
  • K100647 — A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, (July 9, 2010)
  • K082716 — A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H A (January 15, 2009)
  • K082827 — A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT (January 7, 2009)
  • K082985 — A-DEC 334/335 DELIVERY SYSTEM (December 17, 2008)
  • K070663 — A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H S (July 5, 2007)
  • K051657 — A-DEC SELF-CONTAINED WATER SYSTEM (August 30, 2005)
  • K032757 — A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE (December 10, 2003)

Other clearances for product code FLE

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  • K250164 — Cassette Autoclave (ACA5) (August 14, 2025)
  • K243994 — Steam Sterilizer (2545D) (June 6, 2025)
  • K243801 — FRONT-LINE Field Sterilizer (FL135) (March 7, 2025)
  • K233026 — Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer (April 4, 2024)
  • K233504 — Lexa MINI (RIS-303, RIS-305) (February 8, 2024)
  • K233132 — PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (December 19, 2023)
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