LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE

K110131 · 3M Espe Dental Products · EBF · Jan 21, 2011 · Dental

Device Facts

• Record ID: K110131
• Device Name: LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE
• Applicant: 3M Espe Dental Products
• Product Code: EBF · Dental
• Decision Date: Jan 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The product is indicated for inlays, onlays, veneers, and full crown restorations, including crowns on implants.

Device Story

Lava Ultimate CAD/CAM Restorative is a resin-based mill block used for fabricating indirect dental restorations. The material is processed to enhance wear resistance and esthetics. It is intended for use with CAD/CAM milling systems (CEREC or E4D) to produce inlays, onlays, veneers, and crowns, including implant-supported crowns. The device is used in dental clinics by dental professionals. The clinician uses CAD/CAM software to design the restoration based on digital impressions, mills the block into the final shape, and cements the restoration into the patient's mouth. This provides a fast, esthetic alternative to traditional porcelain blocks for restorative dentistry.

Clinical Evidence

Bench testing only. Performance was evaluated by comparing physical and mechanical properties (flexural strength, flexural modulus, compressive strength, diametral tensile strength, water sorption, water solubility, and fracture toughness) against predicate devices. No clinical data was provided.

Technological Characteristics

Tooth-shade resin material (21 CFR 872.3690). Form factor: mill blocks for CAD/CAM systems. Material properties enhanced for milling. No software or electronic components; purely a restorative material.

Indications for Use

Indicated for patients requiring inlays, onlays, veneers, and full crown restorations, including crowns on implants.

Regulatory Classification

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.

Predicate Devices

• 3M™ ESPE™ Paradigm™ MZ100 blocks (K920425)
• 3M™ ESPE™ Filtek™ Supreme Ultra Universal Restorative (K083610)
• 3M™ ESPE™ Filtek™ Supreme Plus (K010781)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] [e-mail]

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

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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.

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#### 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.

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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 [phone] or [phone] 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

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## 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