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510(k) K100647

A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM by A-Dec, Inc. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2010
Date Received
March 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

Other clearances by A-Dec, Inc.

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  • K102234 — A-DEC 200 DENTAL SYSTEM (November 24, 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)
  • K032756 — A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 (December 4, 2003)

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