(20 days)
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.
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.
The provided text does not describe a study involving an AI/CAD device. It pertains to a dental material called "Lava™ Ultimate CAD/CAM Restorative." The 510(k) submission is for a new dental material, not an AI or CAD system that provides diagnostic or prognostic information.
Therefore, many of the requested details about acceptance criteria, study design with AI, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not applicable.
However, I can extract the relevant information regarding the device's performance evaluation and substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "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)."
While specific acceptance criteria (e.g., "must meet X MPa flexural strength") are not explicitly detailed in the provided text, the implied acceptance criterion is that the performance of the Lava™ Ultimate CAD/CAM Restorative is comparable to or superior to the predicate device (Ivoclar Vivadent AG's IPS e.max Press) in in-vitro testing for anterior bridges. The submission indicates this equivalence was demonstrated.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance comparable to predicate device (IPS e.max Press) in "in-vitro testing of prepared anterior bridges." | Demonstrated substantial equivalence through in-vitro testing. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text. The text only mentions "in-vitro testing of prepared anterior bridges."
- Data Provenance: In-vitro testing (laboratory-based). The location of the testing is not specified, but the manufacturer is 3M ESPE Dental Products in St. Paul, MN, USA. The study design is not specifically "retrospective" or "prospective" as it's in-vitro testing of materials, not a clinical study on patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is a material science evaluation, not a diagnostic or prognostic study requiring expert ground truth for interpretation. The "ground truth" would be the objective measurements from the in-vitro mechanical testing.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This is not an AI/CAD diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a dental restorative material, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this material would be objective physical and mechanical properties measured through validated in-vitro testing methods, likely including tests for strength, wear resistance, and esthetics, as implied by the device description.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/CAD system that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable.
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3M ESPE Dental Products 3M Center St. Paul, MN 55144-1000 651 733 1110
SEP 12 2012
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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
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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.
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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).
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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.
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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
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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
§ 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.