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U.S. Department of Health and Human Services

Class 2 Device Recall Lava Ultimate

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  Class 2 Device Recall Lava Ultimate see related information
Date Initiated by Firm June 15, 2015
Date Posted July 08, 2015
Recall Status1 Terminated 3 on April 26, 2016
Recall Number Z-2052-2015
Recall Event ID 71456
510(K)Number K110131  K122569  
Product Classification Material, tooth shade, resin - Product Code EBF
Product Block Versions Used by Dental Offices often referred to as chairside milling:

Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x.

Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x.

Lava Ultimate for Straumann milling centers 1334x.

Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x.

Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x.

Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x.

Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x.

Frame/Blank Version Used by Dental Laboratories:

Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.
Code Information All products in the Lava Ultimate product family.
Recalling Firm/
3M Company - Health Care Business
3M Center 2510 Conway Ave , B# 275-5-W-6
Saint Paul MN 55144
For Additional Information Contact John Cornwell
Manufacturer Reason
for Recall
3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate products. These products will continue to be indicated for onlays, inlays and veneers.
FDA Determined
Cause 2
Device Design
Action 3M ESPE Dental sent an URGENT: MEDICAL DEVICE CORRECTION letter dated June12, 2015 to affected customers. The letter described the affected product, problem and action to be taken. The letter instructed customers to complete and return the Acknowledgement Return/ Refund Form. For questions call 3M ESPE Dental Customer Care center at 1-800-634-2249.
Quantity in Commerce 1.8 million (US 1,017,834)
Distribution Worldwide Distribution - US: Nationwide and the countries of: Australia, India, Japan, Korea, New Zealand, Singapore, Thailand, Vietnam, Canada, Bulgaria, Czech Republic, Estonia, Hungary, Israel, Latvia, Lithuania, Poland, Romania, Slovakia, Switzerland, Turkey, China Hong Kong, Taiwan, Brazil, Colombia, Costa Rica, Guatemala, Mexico, Egypt, Morocco, South Africa, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Netherlands Norway, Portugal, Spain, Sweden, UK and Ireland.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EBF and Original Applicant = 3M COMPANY
510(K)s with Product Code = EBF and Original Applicant = 3M ESPE DENTAL PRODUCTS