DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE

K122065 · Ormco Corp. · NOF · Feb 8, 2013 · Dental

Device Facts

• Record ID: K122065
• Device Name: DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
• Applicant: Ormco Corp.
• Product Code: NOF · Dental
• Decision Date: Feb 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3661
• Device Class: Class 2

Intended Use

The Digital Impression System for Orthodontic Use is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva and/or palate. The Digital Impression System is intended for use in conjunction with the production of orthodontic appliances.

Device Story

Handheld intraoral 3D imager; captures 3D topography of teeth, gingiva, and palate. Operates via blue laser diode (405 nm) using interferometry to measure surface geometry. Video camera in wand captures images; proprietary software processes data into 3D models in real-time. Used in orthodontic offices by orthodontists or assistants; replaces traditional PVS cast impressions. Output is digital 3D file used by manufacturers to design/produce customized orthodontic appliances. System includes handheld wand, computer base unit, and touch screen monitor. Disposable wand tips used for cross-contamination control. Benefits include elimination of traditional impression materials and powdering requirements (unlike predicate), and streamlined digital workflow for appliance fabrication.

Clinical Evidence

No clinical data. Bench testing included biocompatibility studies (cytotoxicity, irritation, sensitization) on disposable wand tips and validation of software performance. 3D topographical accuracy verified by comparing digital files generated by the system against digitized PVS traditional impressions.

Technological Characteristics

Handheld intraoral 3D imager. Light source: 405 nm blue laser diode. Measurement principle: interferometry. Components: handheld wand, computer base unit, touch screen monitor. Connectivity: cable-connected wand to base unit. Disposable single-patient use wand tips. Software: proprietary 3D image acquisition and processing. No tooth coating required.

Indications for Use

Indicated for dental professionals to record topographical characteristics of teeth, gingiva, and/or palate for the production of orthodontic appliances.

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 Unitek Lava Chairside Oral Scanner (K081961)

Submission Summary (Full Text)

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K122065

510(k) Summary

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FEB 8 2013

## Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Wendy Garman - Contact Person

Date Summary Prepared:

February 2013

### Device Name:

- Trade Name Digital Impression System for Orthodontic Use .
- Common Name Intraoral Imaging System .
- Classification Name Optical Impression Systems for CAD/CAM, per 21 CFR § 872.3661 .
- Product Codes Optical Impression System, Computer Assisted Design and Manufacturing . (CAD/CAM) of Dental Restorations (NOF)

### Devices for Which Substantial Equivalence is Claimed:

- 3M Unitek Lava Chairside Oral Scanner, Brontes Technologies, Inc. K081961 .
### Device Description:

The Digital Impression System for Orthodontic Use (DIS) is a handheld intraoral 3D imager intended for use inside the human oral cavity to digitally capture the three-dimensional topography of teeth, gingiva, and/or palate in clinical settings. It is intended to replace traditional cast impressions which are the current standard for recording dental and orthodontic features of patients undergoing orthodontic treatment. The system is intended to be used by orthodontists and orthodontic assistants in an orthodontic office environment. The system consists of a handheld wand connected to a computer which is housed in a base unit. The computer contains proprietary software to acquire, process, and store the digital 3D image data. Patient information is entered into the software using a touch screen monitor connected to the computer. To capture a 3D image of the patient's dental arch and/or bite, the operator

> 1717 West Collins Avenue, Orange, CA 92867 800-537-7824. 714-516-7400.

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moves the wand over the surface of the teeth to be scanned. A video camera inside the wand captures images of the teeth surfaces. Algorithms in the sòftware process these images into a 3D image and display the 3D image on the computer monitor in real time. The software also saves the 3D image data and identifying patient information to be used by orthodontic manufacturers to design and manufacture customized orthodontic appliances.

### Indications for Use:

The Digital Impression System for Orthodontic Use is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate. The Digital Impression System is intended for use in conjunction with the production of orthodontic appliances.

### Summary of Technological Characteristics:

The Digital Impression System for Orthodontic Use is substantially equivalent to another legally marketed device in the United States. The Digital Impression System for Orthodontic Use functions in a manner similar to and is intended for the same use as 3M Unitek Lavo Chairside Oral Scanner that is currently marketed by Brontes Technologies, Inc.

| Features | Digital Impression System for<br>Orthodontic Use | 3M Unitek Lava Chairside Oral<br>Scanner |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Digital Impression System for<br>Orthodontic Use is an optical<br>impression system intended for<br>use by dental professionals to<br>record the topographical<br>characteristics of teeth, gingiva,<br>and/or palate. The Digital<br>Impression System is intended for<br>use in conjunction with the<br>production of orthodontic<br>appliances. | The 3M Unitek Lava Chairside Oral<br>Scanner is an optical impression<br>system (CAD/CAM) used to record<br>the topographical characteristics<br>of teeth. Data generated from the<br>3M Unitek Lava Chairside Oral<br>Scanner may be used in<br>conjunction with the production<br>of orthodontic appliances,<br>retainers and accessories. |
| Target users | Dental Professionals trained in<br>orthodontics | Dental Professionals trained in<br>orthodontics |
| Where used | Dental offices, used at dental chair | Dental offices, used at dental chair |
| Anatomical Sites | Upper and lower arches of teeth,<br>left and right bite | Upper and lower arches of teeth,<br>left and right bite |
| Features | Digital Impression System for<br>Orthodontic Use | 3M Unitek Lava Chairside Oral<br>Scanner |
| Technique to | Interferometry measurement of | Stereoscopic measurement of |

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| Produce 3D Images | video camera images | video camera images |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Light used for illumination | Blue (405 nm) | Blue (405 nm) |
| Light Source | Diode (laser) | Diode (light emitting) |
| Tooth Coating | None | Titanium dioxide powder |
| Components | Handheld imaging wand containing a high accuracy video camera<br>Computer mounted in housing that can be moved from room to room<br>Cable connecting wand with computer<br>Touch screen monitor | Handheld imaging wand containing a high accuracy video camera<br>Computer mounted in housing that can be moved from room to room<br>Cable connecting wand with computer<br>Touch screen monitor |
| Key Characteristics | Handheld wand is moved over the teeth to acquire 3D images<br>Real-time display of 3D images while patient is being imaged | Handheld wand is moved over the teeth to acquire 3D images<br>Real-time display of 3D images while patient is being imaged |
| Device Output | Output is a software file that can be used as input to CAD/CAM dental processes | Output is a software file that can be used as input to CAD/CAM dental processes |
| Patient Contact Areas | Cheek, tongue, lips, teeth, palate | Cheek, tongue, lips, teeth, palate |
| Patient Contact Areas; Cross-contamination Control | Wand tip is single patient/single use disposable | Wand tip must be sterilized between patients |
| Checks of software and hardware function | Scan of verification target | Scan of verification target |

## Non-Clinical Test Data:

Biocompatibility studies (Cytotoxicity, Irritation and Sensitization) have been completed on the disposable wand tip included in the Digital Impression System for Orthodontic Use product.

3D topographical files were created by the Digital Impression System for Orthodontic Use and compared to files derived from, digitized polyvinylsiloxane (PVS) traditional impressions. Test results confirmed that digital impressions generated by the Digital Impression System for Orthodontic Use are substantially equivalent to PVS impressions made by traditional means.

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Additionally, the Digital Impression System for Orthodontic Use software has been successfully validated to confirm the performance of the device.

### Clinical Test Data:

Clinical testing has not been conducted on this product.

### Conclusion:

Based upon the biocompatibility studies, similar technological characteristics to the predicate device, comparison between 3D topographical files created by the Digital Impression System for Orthodontic Use and files created from digitized PVS impressions and successful validation of the Digital Impression System for Orthodontic Use software, the performance of the Digital Impression System for Orthodontic Use is deemed to be substantially equivalent to 3M Unitek Lava Chairside Oral Scanner.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched, symbolizing the department's mission to protect and promote the health and well-being of the nation.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

### February 8, 2013

Ormco Corporation C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties. Incorporated 1717 West Collins Avenue ORANGE CA 92867

Re: K122065

Trade/Device Name: Digital Impression System for Orthodontic Use Regulation Number: 21 CFR 872.3661 Regulation Name: Optical Impression Systems for CAD/CAM Regulatory Class: II Product Code: NOF Dated: February 1, 2013 Received: February 5, 2013

### Dear Ms. Garman:

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 - Ms. Garman

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 devicerelated 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,

Anthony De m

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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KI22065

# Indications for Use

510{k} Number (if known):

Device Name: Digital Impression System for Orthodontic Use

Indications For Use:

The Digital Impression System for Orthodontic Use is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva and/or palate. The Digital Impression System is intended for use in conjunction with the production of orthodontic appliances.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew I. Steen 2013.02.07 15:52:22=05'00'

Division Sianlology, General Hospital

**510(k) Number:** k122065