LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR— 510(k) K122569

Clearance details

Applicant

3M Company

Product code

Code EBF

Device class

Class 2

Regulation

21 CFR 872.3690

Advisory panel

Dental

Date received

2012-08-23

Decision date

2012-09-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Saint Paul, MN, US

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• K261246 — SRGC-062026-06-18

• K243501 — 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE +3 more2025-01-28
• K242538 — 3M Attest Super Rapid Readout Biological Indicator 1493 +4 more2024-11-25
• K241959 — 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD) +3 more2024-10-18
• K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V +3 more2024-09-12
• K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E2024-06-27

• Z-2052-2015 — 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.Class II·Terminated·3M Company - Health Care Business·20150615

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122569.