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A-Dec, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
69
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K213932A-dec 300, A-dec 500March 2, 2022
K133776A-DEC/W&H ELECTRIC HANDPIECE MOTORMay 28, 2014
K102234A-DEC 200 DENTAL SYSTEMNovember 24, 2010
K100647A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LMJuly 9, 2010
K082716A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTAJanuary 15, 2009
K082827A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENTJanuary 7, 2009
K082985A-DEC 334/335 DELIVERY SYSTEMDecember 17, 2008
K070663A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACJuly 5, 2007
K051657A-DEC SELF-CONTAINED WATER SYSTEMAugust 30, 2005
K032757A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLEDecember 10, 2003
K032756A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533December 4, 2003
K032572A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LTDecember 3, 2003
K032070ELCACAMAugust 27, 2003
K022816W & H LISA STEAM STERILIZERFebruary 7, 2003
K010127W & H ASSISTINAOctober 5, 2001
K0009674635 ASSISTANT'S INSTRUMENTATIONMay 3, 2000
K0009664631 DUO DELIVERY SYSTEMMay 3, 2000
K0009683181 DUO DELIVERY SYSTEMMay 3, 2000
K993526SYNEA - LS LOW-SPEED HANDPIECEJanuary 11, 2000
K992011SYNEA-HS HIGH SPEED-HANDPIECESeptember 10, 1999