3M ESPE LAVA CHAIRSIDE ORAL SCANNER

K073199 · Brontes Technologies · NOF · Dec 21, 2007 · Dental

Device Facts

• Record ID: K073199
• Device Name: 3M ESPE LAVA CHAIRSIDE ORAL SCANNER
• Applicant: Brontes Technologies
• Product Code: NOF · Dental
• Decision Date: Dec 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3661
• Device Class: Class 2

Intended Use

The 3M ESPE Lava Chairside Oral Scanner (COS) is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth.

Device Story

3M ESPE Lava Chairside Oral Scanner (COS) is an optical impression system for dental CAD/CAM. System components include a computer, proprietary software, and a handheld dental wand. Operator (dentist/qualified personnel) uses the wand in close proximity to teeth to capture surface images. Software processes inputs to generate a 3D model of teeth, stored with patient information. Accessory includes a patterning powder and sprayer applied to teeth to enhance contrast, resolution, and accuracy of 3D images. Used in clinical dental settings. Output allows clinicians to visualize dental topography for restorative planning.

Clinical Evidence

Bench testing only. Biocompatibility of the patterning powder was evaluated per ISO 10993 standards. Device safety and effectiveness supported by compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-1-4 (programmable electrical medical systems).

Technological Characteristics

Optical impression system; handheld wand scanner; computer-based processing. Materials: Patterning powder meets ISO 10993 biocompatibility requirements. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, ISO 14971. Software: Programmable electrical medical system. Connectivity: Standalone system with disk storage.

Indications for Use

Indicated for recording topographical characteristics of teeth for dental CAD/CAM applications. For prescription use only.

Regulatory Classification

Identification

An optical impression system for computer assisted design and manufacturing (CAD/CAM) is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer-assisted design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.

Special Controls

*Classification.* Class II (Special Controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of the chapter subject to the limitations in § 872.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.” For the availability of this guidance document, see § 872.1(e).

Predicate Devices

• 3M ESPE Lava Chairside Oral Scanner (510K Exempt)
• CEREC 3 Ceramic Dental Restoration System (K994172)

Submission Summary (Full Text)

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K073199

# 5.0 510K Summary

Applicant: Brontes Technologies, Inc. 10 Maguire Road, Suite 310 Lexington, MA 02421 Tel: [phone]

#### Contact: Mark Olsen

DEC 2 1 2007

# 510(k) Numbers and Product Codes of equivalent devices:

Brontes Technologies, Inc. (A 3M Company), Lexington, MA 3M ESPE Lava Chairside Oral Scanner Code: NOF; 510K Exempt

Sirona Dental Systems GmbH. CEREC 3 Ceramic Dental Restoration Systern: Code: ELW; (K994172) S.E. January 7, 2000

### Indications for Use

The 3M ESPE Lava Chairside Oral Scanner is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth.

## Device Description

The 3M ESPE Lava Chairside Oral Scanner (Lava COS) is a system intended to obtain 3D images of the topographical characteristics of Teeth. The System consists of a computer, proprietary software and a hand held dental 'wand' for scanning the surface of the teeth.

Using the wand in close proximity to the teeth, the image of the teeth is communicated to the software and a 3D model is created by the software. The 3D model is then stored on disk along with pertinent patient information.

In this 510K pre-market notification, a powdering material and powder sprayer is added as an accessory. The 'patterning powder' to be applied to the teeth prior to obtaining 3D CAD/CAM images. The powder is intended to enhance the contrast level of the image and allow for better resolution and accuracy of the CAD/CAM images obtained by the 3M ESPE Lava Chairside Oral Scanner System. This powder is similar in composition to powders sold for use with the predicate device and as a 'stand alone' material. The powder provided by Brontes meets the applicable requirements for biocompatibility under the recognized standard ISO 10993 and does not add any new issues of safety or effectiveness.

### Performance Standards

The 3M ESPE Lava Chairside Oral Scanner (COS) meets the following Performance Standards:

- . Tripartite Guidance - 1987 (G87-1)

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- Special Controls Guidance Document: Optical Impression Systems for . Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA
- ISO/EN 10993-1; 1997 Biological Evaluation of Medical Devices, Part . I: Evaluation and Testing
- ISO/EN 10993-5; 1999 Tests for In-Vitro Cytotoxicity, 200 Ed .
- . ISO/EN 10993-10; 2002 Tests for Irritation and Delayed Type Hypersensitivity, 2nd Ed
- . IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety
- IEC 60601-1-2 Medical Electrical Equipment Part 1 General . Requirements for Safety; Electromagnetic Compatibility -Requirements and Tests
- IEC 60601-1-4 medical Electrical Equipment Part 1 Medical . Electrical Equipment part 1-4: General Requirements for Collateral Standard: Programmable Electrical Medical Systems
- FDA Guidance on Dental Handpieces (Draft) July 1995 .
- ISO 7405 Pre-Clinical evaluation of Biocompatibility of medical . devices used in dentistry, test methods for dental materials.
- FDA; Guidance for the Content of Pre-market Submissions for . Software Contained in Medical Devices - May 2005
- . FDA Guidance; Cyber Security for Networked Medical Devices Containing Off the Shelf Software
- . ISO 14971 - Medical devices - Risk management - Part 1: Application of risk analysis

### Conclusion:

There are more similarities than differences between the predicate devices and the 3M ESPE Lava Chairside Oral Scanner (COS). The predicate devices and 3M ESPE Lava Chairside Oral Scanner have the same intended use, warnings and contraindications. Both the 3M ESPE Lava Chairside Oral Scanner and predicate device (CEREC 3) may be used with a powder and powdering delivery system. When used in accordance with the instructions for use, by qualified personnel, the 3M ESPE Lava Chairside Oral Scanner is safe and effective, as indicated, for the intended use.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2007

Brontes Technologies, Incorporated C/O Mr. John Greenbaum President Generic Devices Consulting, Incorporated 20310 SW 48th Street Southwest Ranches, Florida 33332

Re: K073199

Trade/Device Name: 3M ESPE Lava Chairside Oral Scanner (COS) Regulation Number: 21 CFR 872.3661 Regulation Name: Optical Impression Systems for CAD/CAM Regulatory Class: II Product Code: NOF Dated: November 13, 2007 Received: November 13, 2007

Dear Mr. Greenbaum:

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.

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 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 your device in the Federal Register.

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Page 2 - Mr. Christenson

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); 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,

*Sheila H. Murphy, DPs, Charter R.*

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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Page 1 of 1

510(k) Number (if known): K073199

Device Name: 3M ESPE Lava Chairside Oral Scanner (COS)

Indications For Use:

The 3M ESPE Lava Chairside Oral Scanner (COS) is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth.

Prescription Use X (Per 21 CRF 801.109)

OR

Over - The - Counter Use

# PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 1-2-96)

(Division Sign-Off Division of Anesthesiology C neral Hospital Infection Control, Dental Devices

510(k) Number: K073144