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U.S. Department of Health and Human Services

Class 2 Device Recall SEAC Advanced Dental System

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 Class 2 Recall
SEAC Advanced Dental System
see related information
Date Posted December 19, 2013
Recall Status1 Terminated on August 11, 2014
Recall Number Z-0545-2014
Recall Event ID 66983
Premarket Notification
510(K) Number
K974487 
Product Classification Unit, Operative Dental - Product Code EIA
Product SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra® oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.
Code Information Code No: 2010, 2020,2120 and 2220 Serial No: 590341- 592066
Recalling Firm/
Manufacturer
ASI Medical, Inc.
14550 E Easter Ave Ste 700
Centennial, Colorado 80112-4271
For Additional Information Contact Amy H Nguyen
303-766-3646
Manufacturer Reason
for Recall
ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.
FDA Determined
Cause 2
DESIGN: Device Design
Action ASI Medical sent an Field Correction Action and Safety Notice letter dated November 5, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. REQUIRED FIELD CORRECTION Our field correction will consist of sending you a warning label to be applied to the back service access panel of the cart and an ASME safety pop off valve that will open and exhaust if pressure should reach over 100 psi. This safety pop off valve is designed be easily installed in line between the air compressor and air tank in your system. We are requesting your cooperation in making this field correction.
Quantity in Commerce 337
Distribution Worldwide Distribution - USA (nationwide) including the countries of Austria, Aruba, Saudi Arabia, Canada, Germany, Spain and West Indies.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = EIA and Original Applicant = ASI MEDICAL, INC.
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