(20 days)
No
The summary describes a dental restorative material (mill block) and its intended uses and properties. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
This device is a restorative material used for dental restorations like crowns and bridges, not designed to diagnose, cure, mitigate, treat, or prevent disease.
No
The device description indicates it is a restorative material (mill block) for CAD/CAM indirect restorations, not a tool for diagnosing medical conditions. Its intended use is for creating dental restorations like inlays, onlays, and crowns.
No
The device description clearly states the product is a "mill block," which is a physical material used for milling dental restorations. This is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a material for creating dental restorations (inlays, onlays, crowns, bridges). This is a therapeutic and restorative application, not a diagnostic one.
- Device Description: The device is described as a "mill block" for creating these restorations. This aligns with a material used in a manufacturing process for medical devices, not a diagnostic test.
- Lack of Diagnostic Language: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Anatomical Site: The anatomical sites mentioned (anterior and premolar regions) refer to where the restorations will be placed, not where a diagnostic sample would be taken from.
In summary, the device is a material used to create dental prosthetics, which falls under the category of a medical device for restoration and treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Lava Ultimate restorative is indicated for inlays, onlays, veneers, full crown restorations, including implant supported crowns, permanent three unit bridges in the anterior region and permanent three unit bridges in the premolar region up to the second premolar as the terminal abutment. The bridge consists of two full crown abutments supporting a pontic between them; the two abutments may be either two teeth or two implants.
Lava Ultimate restorative is not indicated for uses other than those listed.
Product codes
EBF
Device Description
The product is a strong, wear-resistant and highly esthetic mill block that provides a fast and easy-to-use alternative to porcelain blocks for milling CAD/CAM indirect restorations. The material is specially processed to enhance its properties for use in CAD/CAM milling procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
This 510(k) submission includes data from in-vitro testing of prepared anterior bridges to evaluate the performance of Lava™ Ultimate CAD/CAM Restorative compared to Ivoclar Vivadent AG's IPS e.max Press (K982616).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
in-vitro testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
3M ESPE Dental Products 3M Center St. Paul, MN 55144-1000 651 733 1110
SEP 12 2012
Image /page/0/Picture/4 description: The image shows the logo for 3M ESPE. The logo is in black and white. The text is bold and sans-serif.
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く
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
510(k) Submitter .................................... 3M Company 3M ESPE Dental Products 3M Center, Bldg. 275-2W-08 St. Paul, MN 55144-1000 USA
Contact person ............................................................................................................................................................... Regulatory Affairs Specialist
Phone: (651) 733-1317 Fax: (651) 737-9665 gcantor@mmm.com
Date Summary was Prepared ............August 21, 2012
Trade Name ................................................................................................................................................................... CEREC® Lava™ Ultimate CAD/CAM Restorative for E4D® Lava™ Ultimate Implant Crown Restorative Lava™ Ultimate CAD/CAM Restorative for Straumann®
.... Dental material, filling/restorative, polymer Common Name(s) ......................... based
Lava™ Ultimate CAD/CAM Restorative 510k 510k Summary, August 21, 2012
1
Recommended Classification ... ...... Tooth shade resin material (21 CFR 872.3690. Product Code: EBF)
Predicate Devices:
な
3M ESPE's Lava Ultimate CAD/CAM Restorative (K110131) Ivoclar Vivadent AG's IPS e.max Press (K982616)
Description of Device:
The product is a strong, wear-resistant and highly esthetic mill block that provides a fast and easy-to-use alternative to porcelain blocks for milling CAD/CAM indirect restorations. The material is specially processed to enhance its properties for use in CAD/CAM milling procedures.
Indications for Use:
Lava Ultimate restorative is indicated for inlays, onlays, veneers, full crown restorations, including implant supported crowns, permanent three unit bridges in the anterior region and permanent three unit bridges in the premolar region up to the second premolar as the terminal abutment. The bridge consists of two full crown abutments supporting a pontic between them; the two abutments may be either two teeth or two implants.
Lava Ultimate restorative is not indicated for uses other than those listed.
Contraindications
Lava Ultimate is contraindicated for bridges in patients with parafunctional habits such as bruxism (hyperfunction) or clenching.
2
Substantial Equivalence:
Information provided in this 510(k) submission shows that the product is substantially equivalent to the 3M ESPE's predicate device Lava Ultimate (K110131) and to Ivoclar Vivadent AG's IPS e.max Press (K982616).
This 510(k) submission includes data from in-vitro testing of prepared anterior bridges to evaluate the performance of Lava™ Ultimate CAD/CAM Restorative compared to Ivoclar Vivadent AG's IPS e.max Press (K982616).
No additional biocompatibility testing was required to support the submission the formulation of Lava Ultimate has not changed since clearance of its original 510(k) (K110131).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP
12
2012
3M Company C/O Mr. Mark Job Regulatory Technology Services, Limited Liability Company 1394 25TH Street, North West Buffalo, Minnesota 55313
Re: K122569
Trade/Device Name: Lava™ Ultimate Cad/Cam Restorative for Cerec® Lava™ Ultimate Cad/Cam Restorative for E4D® Lava™ Ultimate Implant Crown Restorative Lave™ Ultimate Cad/Cam Restorative for Straumann® Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 7, 2012 Received: September 10, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898.
4
Page 2- Mr. Job
In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Lava™ Ultimate CAD/CAM Restorative
Indications for Use:
Lava Ultimate restorative is indicated for inlays, onlays, veneers, full crown restorations, including implant supported crowns, permanent three unit bridges in the anterior region and permanent three unit bridges in the premolar region up to the second premolar as the terminal abutment. The bridge consists of two full crown abutments supporting a pontic between them; the two abutments may be either two teeth or two implants.
Lava Ultimate restorative is not indicated for uses other than those listed.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Suropo
stheslology, General Hospital
510(k) Number: K122569
3M ESPE Dental Products