3M TRUE DEFINITION SCANNER

K122467 · 3M Company · NOF · Nov 20, 2012 · Dental

Device Facts

• Record ID: K122467
• Device Name: 3M TRUE DEFINITION SCANNER
• Applicant: 3M Company
• Product Code: NOF · Dental
• Decision Date: Nov 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3661
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

3M True Definition Scanner is an optical impression system used to record the topographical characteristics of the dentition and/or full arch and preparation areas (including features such as implant scan locator fixtures, braces, brackets, etc.). In addition it can record the topographical characteristics of the oral anatomy (such as soft tissue, gingivae and palate). The three dimensional (3D) model generated from the scan may be further used for the design and manufacturing of dental restorations including implant supported prostheses and partial frameworks, and can be used to design and manufacture physical models of the teeth. It may also be used in conjunction with production of orthodontic appliances, retainers and accessories.

Device Story

Digital impression system; captures high-resolution video of oral anatomy via handheld optical scanning wand. Wand uses low-intensity LEDs and light sensor; captures video at 20 fps; converts to 3D data sets in real-time. System includes mobile cart, PC, touch screen, and contrast powder/sprayer. Used by dentists/clinicians in clinical settings. Software performs image processing, real-time modeling, case management, and archival. Facilitates digital workflow; eliminates traditional steps like tray selection, plaster pouring, and physical shipping. Output is 3D model used for CAD/CAM design/manufacturing of restorations, models, and orthodontic appliances. Benefits include improved accuracy and streamlined clinical workflow.

Clinical Evidence

Bench testing only. Software verification and validation performed, including accuracy, case processing, data management, and workflow testing. Accuracy testing showed 0.13% initial average error and 0.22% initial max error, compared to 0.57% and 0.74% for predicate devices, respectively. Biocompatibility testing conducted per ISO 10993-1 and ISO 7405. Electrical safety and EMC testing performed per ANSI/AAMI ES60601-1 and IEC 60601-1-2. Photobiological safety confirmed per IEC 62471.

Technological Characteristics

Optical impression system; handheld wand with 6 LEDs (465 nm) and single imaging sensor. PC-based (Intel Xeon) running Fedora 15 Linux. Connectivity via wireless 802.11 b/g/n and USB 3.0. Contrast powder contains titanium dioxide, amorphous silica, and aluminium hydroxide. Biocompatible materials per ISO 10993-1/ISO 7405. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2; photobiological safety per IEC 62471.

Indications for Use

Indicated for recording topographical characteristics of dentition, full arch, preparation areas (implants, braces, brackets), and oral anatomy (soft tissue, gingivae, palate) in patients requiring dental restorations, implant-supported prostheses, partial frameworks, physical models, or orthodontic appliances/retainers.

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 (C.O.S.) (K073199)
• 3M Unitek Lava Chairside Oral Scanner (C.O.S.) (K081961)

Submission Summary (Full Text)

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122467

3M ESPE Dental Products 3M Center St. Paul, MN 55144-1000 651 733 1110

NOV 2 0 2012

Image /page/0/Picture/4 description: The image shows the logo for 3M ESPE. The logo is in black and white. The text is in a sans-serif font.

# 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, 275-2W-08 2510 Conway Avenue St. Paul, MN 55144-1000 USA Contact person .......................................... Ginger Cantor, RAC Regulatory Affairs Advanced Specialist Phone: [phone] Fax: [phone] [e-mail] Date Summary was Prepared .......... November 16, 2012 Trade Name ................................................................................................................................................................... Common Name(s) ..............................Intra-Oral Scanner Recommended Classification ........... Optical Impression Systems for

CAD/CAM, Class II device, (21 CFR § 872.3661, Product Code: NOF)

3M True Definition Scanner 510k 510(k) Summary, November 16, 2012 3M ESPE Dental Products

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### Predicate Devices:

3MTM ESPETM Lava Chairside Oral Scanner (C.O.S.), K073199 3MTM Unitek™ Lava Chairside Oral Scanner (C.O.S.), K081961

## Description of Device:

The 3M True Definition Scanner is a digital impression generating system consisting of a computer system on a mobile cart, a lightweight scanning wand, and embedded software (including firmware). Accessory items include a contrast powder to be applied to the patient's teeth and/or oral anatomy and a battery powered powder sprayer.

The computer system consists of a commercial off-the-shelf personal computer (PC) and a touch screen monitor.

The scanning wand is a hand held optical device that captures high-resolution video images, in real time, as the patient is being scanned. The wand contains an optical system comprised of low intensity LED's, a light sensor, a lens and supporting electronics. The wand is connected to the cart via a high speed data transfer cable. The wand is designed to be easily maneuvered inside the patient's mouth and captures video imagery at 20 frames per second. Those images are converted to 3D data sets and displayed in real time.

The software contains high-speed image processing algorithms, real-time modeling, case management, and archival functionality.

3M True Definition Scanner facilitates a digital workflow which reduces or eliminates many steps traditionally required by the dentist and lab, including tray selection, plaster pouring, material dispensing, base & pin, material setting, die cutting, trimming, articulation, packaging and shipping.

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#### Indications for Use:

3M True Definition Scanner is an optical impression system used to record the topographical characteristics of the dentition and/or full arch and preparation areas (including features such as implant scan locator fixtures, braces, brackets, etc.). In addition it can record the topographical characteristics of the oral anatomy (such as soft tissue, gingivae and palate).

The three dimensional (3D) model generated from the scan may be further used for the design and manufacturing of dental restorations including implant supported prostheses and partial frameworks, and can be used to design and manufacture physical models of the teeth.

It may also be used in conjunction with production of orthodontic appliances, retainers and accessories.

### Electrical Safety/Electromagnetic Compatibility (EMC)

3M ESPE provided data in the 510(k) to demonstrate the device meets the requirements of ANSI/AAMI ES60601-1:2005 (i.e., IEC 60601-1: 2005), Medical electrical equipment - Part1: General requirements for basic safety and essential performance, IEC60601-1:1998 + A1:1992 + A1:1995, Medical electrical equipment – Part 1: General requirements for safety, and IEC 60601-1-2: 2007, Medical Electrical Equipment -Part 1: General Requirements for Safety: Collateral Standard: Electromagnetic Compatibility Requirements and Tests.

In addition, information was provided in the 510(k) to demonstrate the 3M True Definition Scanner meets the requirements of IEC62471:2006, Photobiological safety of lamps and lamp systems.

3M concludes that the 3M True Definition Scanner is safe for its intended use/indications for use.

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#### Biocompatibility

3M provided data in this 510(k) to demonstrate the 3M True Definition Scanner meets the requirements of relevant parts of ISO10993-1(2009), Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process and that the device meets the requirements of ISO 7405: 2008, Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry.

#### Non-Clinical Testing

3M successfully performed software verification and validation activities including testing of the device's accuracy, case processing, data management, fault management, network access and remote service, patient, doctor and prescription management, scanning operations and workflows to laboratories and mills. Results of accuracy testing are shown in the Substantial Equivalence summary below.

#### Substantial Equivalence:

3M ESPE's evaluation of the substantial equivalence of the True Definition Scanner to the Lava C.O.S. predicates was based on a comparison of device classification, intended use and indications for use, contraindications, labeling, technological attributes, accuracy, and accessories. 3M also compared risks and End-of Useful Life for both devices.

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| Comparison of Intended Use/Indications for Use/Contraindications | | | |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | 3M True Definition<br>Scanner<br>(FDA 510(k)# K122467) | 3M ESPE Lava C.O.S.<br>(FDA 510(k)# K073199) | 3M Unitek Lava C.O.S.<br>(FDA 510(k)# K081961) |
| Procode | NOF | NOF | NOF |
| Classification | Optical Impression<br>System for CAD/CAM<br>21 CFR §872.3661 | Optical Impression<br>System for CAD/CAM<br>21 CFR §872.3661 | Optical Impression System<br>for CAD/CAM<br>21 CFR §872.3661 |
| Indications for Use | 3M True Definition<br>Scanner is an optical<br>impression system used to<br>record the topographical<br>characteristics of the<br>dentition and/or full arch<br>and preparation areas<br>(including items such as<br>implant scan locator<br>fixtures, braces, brackets,<br>etc.). In addition, it can<br>record the topological<br>characteristics of the oral<br>anatomy (such as soft<br>tissue, gingivae, and<br>palate).<br><br>The three dimensional<br>(3D) model generated<br>from the scan may be<br>further used for the design<br>and manufacturing of<br>dental restorations<br>including implant<br>supported prostheses and<br>partial frameworks, and<br>can be used to design and<br>manufacture physical<br>models of the teeth.<br>It may also be used in<br>conjunction with the<br>production of orthodontic<br>appliances, retainers and<br>accessories. | The 3M ESPE Lava<br>Chairside Oral Scanner<br>(C.O.S.) is an optical<br>impression system<br>(CAD/CAM) used to<br>record the topographical<br>characteristics of teeth. | The 3M Unitek Lava<br>Chairside Oral Scanner<br>(C.O.S.) is an optical<br>impression system<br>(CAD/CAM) used to record<br>the topographical<br>characteristics of teeth.<br><br>Data generated from the 3M<br>Unitek Lava Chairside Oral<br>Scanner may be used in<br>conjunction with the<br>production of orthodontic<br>appliances, retainers and<br>accessories. |
| Contra-indications | None | None | None |

:

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| Technological Comparison | | | | | | | |
|-------------------------------------|--------------------------------------------|----------------------------------------------------------|-------------------------------------------------------|--|--|--|--|
| Item | 3M True Definition<br>Scanner<br>(K122467) | Lava C.O.S.<br>(510(k)# K073199) | Lava C.O.S.<br>(510(k)# K081961) | | | | |
| Operating System | Fedora 15 (Linux) | Custom Gentoo Linux | Custom Gentoo Linux | | | | |
| Computer Hardware | Intel XEON processor -<br>closed system | AMD based processor -<br>closed system | AMD based processor - closed<br>system | | | | |
| Internet<br>Communications | Wireless 802.11 b/g/n | Wireless 802.11 b/g/n | Wireless 802.11 b/<br>g/n | | | | |
| Scanning Wand<br>Computer Interface | USB 3.0 Interface | Proprietary serial<br>interface to custom PCI<br>adapter | Proprietary serial interface to<br>custom PCI adapter | | | | |
| Scanning Wand<br>Imaging Sensor(s) | Single | Three | Three | | | | |
| Scanning Wand | 6 LEDs | 192 LEDs | 192 LEDs | | | | |
| LEDs (# and<br>wavelength) | (465 nm wavelength) | (465 nm wavelength) | (465 nm wavelength) | | | | |
| Isolation Transformer | Powertronix Isolation<br>StationTM | Custom built | Custom built | | | | |

| Accuracy Comparison | | |
|------------------------------|-----------------------------------------|-----------------------------------|
| Parameter | 3M True Definition Scanner<br>(K122467) | Lava COS<br>(K073199 and K081961) |
| Initial Average<br>Error (%) | 0.13% | 0.57% |
| Initial Max Error<br>(%) | 0.22% | 0.74% |

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| Accessories Comparison | | | | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | 3M True Definition<br>Scanner<br>(K122467) | 3M ESPE Lava<br>C.O.S.<br>(510(k)# K073199) | 3M Unitek Lava<br>C.O.S.<br>(510(k) #081961) | Comments |
| Contrast<br>patterning<br>Powder | Composition:<br>• titanium dioxide<br>• amorphous silica<br>• aluminium<br>hydroxide<br>• synthetic<br>• amorphous silica | Composition:<br>• titanium dioxide<br>• amorphous silica<br>• aluminium<br>hydroxide<br>• synthetic<br>• amorphous silica | Composition:<br>• titanium dioxide<br>• amorphous silica<br>• aluminium<br>hydroxide<br>• synthetic<br>• amorphous silica | No change- the<br>same powder<br>described in<br>K073199 was<br>used in K081961<br>and will be used<br>for the 3M True<br>Definition<br>Scanner |
| Powder delivery<br>device | Battery (9V) powered<br>sprayer | Battery (9V) powered<br>sprayer | Battery (9V) powered<br>sprayer | No change - the<br>same sprayer<br>described in<br>K073199 was<br>used in K081961<br>and will be used<br>for the 3M True<br>Definition<br>Scanner |

3M ESPE concludes that 3M True Definition Scanner is substantially equivalent to the named predicate devices (3M ESPE Lava C.O.S. (K073199) and 3M Unitek Lava C.O.S (K081961)). Any differences between the 3M True Definition Scanner and the predicate(s) do not raise new questions of safety or efficacy.

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or an abstract human figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

#### November 20, 2012

3M Company C/O Mr. Mark Job Regulatory Technology Services, Limited Liability Company 1394 25TH Street, North West Buffalo, Minnesota 55313

Re: K122467

Trade/Device Name: 3M True Definition Scanner (Model G5) Regulation Number: 21 CFR 872.3661 Regulation Name: Optical Impression Systems for CAD/CAM Regulatory Class: II Product Code: NOF Dated: November 2, 2012 Received: November 5, 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. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Job

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulme

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, 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): K122467

Device Name: 3M True Definition Scanner (Model G5)

Indications for Use:

3M True Definition Scanner is an optical impression system used to record the topographical characteristics of the dentition and/or full arch and preparation areas (including features such as implant scan locator fixtures, braces, brackets, etc.). In addition it can record the topographical characteristics of the oral anatomy (such as soft tissue, gingivae and palate).

The three dimensional (3D) model generated from the scan may be further used for the design and manufacturing of dental restorations including implant supported prostheses and partial frameworks, and can be used to design and manufacture physical models of the teeth.

It may also be used in conjunction with production of orthodontic appliances, retainers and accessories.

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 Runner DDS, MA >05'00' 2012.11.20 12:13:34

> (Division Sign-Off) (Division Sign-Off)
> Division of Anesthesiology, General Hospital Division of Atlest.ico.org/?
> Infection Control, Dental Devices

K122467 510(k) Number:

3M True Definition Scanner 510(k) 02 July 2012

3M ESPE Dental Products