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510(k) K925367

A-DEC 7284 CUSPIDOR, CASCADE by A-Dec, Inc. — Product Code EBR

K925367 is an FDA 510(k) premarket notification submitted by A-Dec, Inc. for the device "A-DEC 7284 CUSPIDOR, CASCADE". The FDA issued a decision of Substantially Equivalent on April 11, 1994. The device falls under product code EBR (Unit, Suction Operatory), a Class I device regulated under 21 CFR 872.6640. A-Dec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1994
Date Received
October 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Suction Operatory
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Other clearances by A-Dec, Inc.

  • K213932 — A-dec 300, A-dec 500 (March 2, 2022)
  • 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 EBR

  • K860058 — DENPAX (March 12, 1986)
  • K770600 — OROPHARYNGEAL SUCTION AIRWAY (April 8, 1977)

FDA data resources