LAVA SOFTWARE

K062493 · 3M Espe AG Dental Products · NHA · Nov 17, 2006 · Dental

Device Facts

• Record ID: K062493
• Device Name: LAVA SOFTWARE
• Applicant: 3M Espe AG Dental Products
• Product Code: NHA · Dental
• Decision Date: Nov 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Lava software is used with 3M ESPE's Lava system, an all-ceramic system for the CAD/CAM fabrication of dental restorations such as inlays, onlays, veneers, crowns and bridges. The software controls the measuring process, processing of the measurement data (3D-CAD tool), and export of the data to the milling machine. In addition, various patient and case information elements can be entered. Other functions are available for verification and service of the measuring system. The Lava software also facilitates the transfer of 3D data from a scanner to a remote milling machine via internet.

Device Story

Lava software functions as part of 3M ESPE's Lava system for CAD/CAM dental restoration fabrication. Input consists of measurement data from a scanner; software processes this 3D data (CAD) and manages patient/case information. Output is digital data exported to a milling machine for restoration production. A software module enables transfer of 3D scan or modeled data to remote milling facilities via secure internet connection. Used in clinical dental settings; operated by dental professionals. Facilitates digital workflow for custom dental prosthetics; improves efficiency in restoration fabrication.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based CAD/CAM system for dental restoration fabrication. Features include 3D measurement control, data processing, and secure internet-based data transfer to remote milling machines. Operates as a component of the Lava system.

Indications for Use

Indicated for use in the CAD/CAM fabrication of dental restorations including inlays, onlays, veneers, crowns, and bridges.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• Procera® Software by Nobel Biocare USA LLC (K053602)

Submission Summary (Full Text)

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K062493

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

NOV 1 7 2008

## Submitter

| Company: | 3M ESPE AG |
|------------------------------------|------------------------------------------------------|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann,<br>Manager Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | [e-mail] |

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K069493

#### Name of Device

Lava software Proprietary Name: Porcclain powder for clinical use Classification Name All-ceramic core material Common Name: All-ceramic overlay material

Predicate Device:

Procera® Software by Nobel Biocare USA LLC, K053602

#### Description for the Premarket Notification

The Lava™ software is used with 3M ESPE's Lava™ system, an all-ceramic system for the CAD/CAM fabrication of dental restorations such as inlays, onlays, veneers, crowns and bridges. The Lava software controls the measuring process, editing of the measurcment data (CAD), and export of the data to the milling machine. A software module of the Lava satellite scanner facilitates the transfer of 3D data (plain scan data or fully modeled data) to the remote milling machine via internet by a secured internet connection.

In summary, Lava™ software as described in this 510(k) premarket notification submission is, in our opinion, substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Sabine Krisher 3M ESPE AG ESPE Platz D-82229 Seefeld Bavaria GERMANY

NOV 17 2006

Re: K062493

Trade/Device Name: Lava Software Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA, EIH Dated: August 22, 2006 Received: August 25, 2006

Dear Dr. Krischer:

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 grenal 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations offecting 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 your device in the Federal Register.

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### Page 2 - Dr. Krischer

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Suon Pusone

Te-Chia Lin, Ph.D.

Chiu Lin, Ph.D. 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

K062493 510(k) Number (if known):

Device Name: Lava software

Indications For Use: The Lava software is used with 3M ESPE's Lava system, an all-ceramic system for the CAD/CAM fabrication of dental restorations such as inlays, onlays, veneers, crowns and bridges.

The software controls the measuring process, processing of the measurement data (3D-CAD tool), and export of the data to the milling machine. In addition, various patient and case information elements can be entered. Other functions are available for verification and service of the measuring system.

The Lava software also facilitates the transfer of 3D data from a scanner to a remote milling machine via internet.

Swal Burgess

113 35577-6 318) n of Anesthesiology, General Hospital. n Control, Dental Devic

umber K062493

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)