(3 days)
The product is indicated for inlays, onlays, veneers, and full crown restorations, including crowns on implants.
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 describes a 510(k) submission for a dental restorative material, not a software or AI-powered medical device. Therefore, the information requested about acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies, human reader improvement, standalone performance, and training set information) is not applicable or cannot be extracted from this document.
The document primarily focuses on demonstrating substantial equivalence to predicate dental devices through bench testing of physical properties.
However, I can extract the general "acceptance criteria" in the context of this device being approved based on comparison to predicates and meeting certain material properties.
1. Table of Acceptance Criteria and Reported Device Performance
| Property Evaluated | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Implied by Substantial Equivalence Determination) |
|---|---|---|
| Flexural Strength | Comparable to predicate devices | Deemed substantially equivalent |
| Flexural Modulus | Comparable to predicate devices | Deemed substantially equivalent |
| Compressive Strength | Comparable to predicate devices | Deemed substantially equivalent |
| Diametral Tensile Strength | Comparable to predicate devices | Deemed substantially equivalent |
| Water Sorption | Comparable to predicate devices | Deemed substantially equivalent |
| Water Solubility | Comparable to predicate devices | Deemed substantially equivalent |
| Fracture Toughness | Comparable to predicate devices | Deemed substantially equivalent |
| Biocompatibility | Safe for intended use (based on risk assessment) | Deemed safe for intended use |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for each test. The document states "data from bench testing" was used.
- Data Provenance: Bench testing, likely conducted by 3M ESPE Dental Products. No information about country of origin, retrospective or prospective is relevant as it's a material test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This is a material science study, not one requiring expert human interpretation for "ground truth" as you would find in an imaging or diagnostic device. The "ground truth" here is the measured physical properties of the material and its comparison to established predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, not for bench testing of material properties.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-powered device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this type of material device is derived from standardized bench test measurements of physical and chemical properties and comparison to the established performance of legally marketed predicate devices. Biocompatibility was assessed through a "risk assessment techniques and consideration of FDA & internationally recognized guidelines."
8. The sample size for the training set:
- Not applicable. This is not an AI-powered device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI-powered device.
{0}------------------------------------------------
K11.013|
3M ESPE Dental Products 3M Center St. Paul, MN 55144-1000 651 733 1110
JAN 2 1 2011
3M ESPE
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. 260-2A-11 St. Paul, MN 55144-1000 USA
Contact person ....................................... Ginger Cantor, RAC
Regulatory Affairs Specialist Phone: (651) 733-1317 Fax: (651) 737-6049 gcantor@mmm.com
Date Summary was Prepared..........December 29, 2010
Trade Name...........................................Lava™ Ultimate CAD/CAM Restorative for CEREC® Lava™ Ultimate CAD/CAM Restorative for E4D® Lava™ Ultimate CAD/CAM Implant Crown Restorative
Common Name(s)................................................................................................................................................................ based
3M ESPE Dental Products
{1}------------------------------------------------
Recommended Classification............Tooth shade resin material, (21 CFR 872.3690, Product Code: EBF)
Predicate Devices:
3M™ ESPE™ Paradigm™ MZ100 blocks (K920425) 3M™ ESPETM Filtek™ Supreme Ultra Universal Restorative (K083610) 3M™ ESPETM Filtek™ Supreme Plus (K010781)
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:
The product is indicated for inlays, onlays, veneers, and full crown restorations, including crowns on implants.
Substantial Equivalence:
Information provided in this 510(k) submission shows that the product is substantially equivalent to the 3M ESPE's predicate devices Paradigm™ MZ100 block, FiltekTM Supreme Ultra Universal Restorative, and Filtek™M Supreme Plus,
A biocompatibility assessment was developed for this new product using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines. The conclusion of the assessment is that the product is safe for its intended use.
This 510(k) submission includes data from bench testing to evaluate the performance of the product compared to predicate devices Paradigm™ MZ100 block, Filtek™ Supreme Ultra Universal Restorative, and Filtek™ Supreme Plus. Properties evaluated include Flexural Strength, Flexural Modulus, Compressive Strength, Diametral Tensile Strength, Water Sorption, Water Solubility and Fracture Toughness.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Ginger Cantor, RAC Regulatory Affairs Specialist 3M ESPE Dental Products 3M Center. Bldg. 260-2A-11 St. Paul, MN 55144-1000
JAN 2 1 201
Re: K110131
Trade/Device Names: Lava™ Ultimate CAD/CAM Restorative for CEREC® Lava™ Ultimate CAD/CAM Restorative for E4D® Lava™ Ultimate CAD/CAM Implant Crown Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material
Regulatory Class: II Product Codes: EBF and EBG Dated: January 17, 2011
Received: January 18, 2011
Dear Ms. Cantor:
·
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. In addition, FDA may publish further announcements concerning vour device in the Federal Register.
{3}------------------------------------------------
Page 2 - Ms. Cantor
Enclosure
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 l'ederal 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.html 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. .
Anthony D.m
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
{4}------------------------------------------------
Indications for Use
ાજીક 510(k) Number (if known):
Device Name: Lava™ Ultimate CAD/CAM Restorative for CEREC® Lava™ Ultimate CAD/CAM Restorative for E4D® Lava™ Ultimate CAD/CAM Implant Crown Restorative
Indications for Use:
The product is indicated for inlays, onlays, veneers, and full crown restorations, including crowns on implants.
Prescription Use X (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 Dunne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110631
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.