INSIGNIA DIGICAST

K123118 · Ormco Corp. · DYW · Mar 26, 2013 · Dental

Device Facts

• Record ID: K123118
• Device Name: INSIGNIA DIGICAST
• Applicant: Ormco Corp.
• Product Code: DYW · Dental
• Decision Date: Mar 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

Insignia Digicast is a computer aided system intended for use as an aid in orthodontic diagnostics for use by dental professionals trained in orthodontic treatment including radiographic analyses and diagnostics.

Device Story

Insignia Digicast is a software-based service creating 3D digital study models of patient dentition. Process: dental professional takes traditional alginate or PVS impression; impression scanned; scan processed into digital model; model electronically delivered to clinician. Clinician uses 3D viewer software to perform measurements and analyses (Bolton, Tanaka-Johnston/Moyers, space analysis, ABO discrepancy index, arch/overbite/overjet measurements). Used in dental clinics by trained professionals to support diagnosis and record dentition status prior to treatment. No patient-contacting components.

Clinical Evidence

No clinical testing conducted. Substantial equivalence supported by bench testing comparing performance characteristics (teeth width, space, T-J Moyers, Bolton, Arch, Overbite/Overjet) against the predicate device, OrthoCAD iQ. Software validation confirmed device performance.

Technological Characteristics

Software-based digital study model system. Inputs: scanned traditional alginate or PVS impressions. Outputs: 3D digital models for clinician analysis. Features include automated measurement tools for orthodontic indices. Connectivity: electronic delivery of digital models to dental professionals. No patient-contacting components.

Indications for Use

Indicated for use by dental professionals trained in orthodontic treatment as an aid in orthodontic diagnostics, including radiographic analyses and diagnostics.

Regulatory Classification

Identification

An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

Predicate Devices

• Lava Digital Models (3M Unitek)
• OrthoCAD iQ (Cadent, Inc.) (K082207)

Submission Summary (Full Text)

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K123118

Image /page/0/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo consists of the letters "sds" in a bold, sans-serif font, with a curved line above the letters. Below the letters, the words "Sybron Dental Specialties" are written in a smaller, sans-serif font. The logo is simple and modern, and the use of bold fonts makes it easily recognizable.

MAR 2 6 2013

# 510K SUMMARY

#### Submitter:

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

Date Summary Prepared: March 2013

- . Trade name - Insignia Digicast
- Common name -Digital Study Model
- Classification name Orthodontic Plastic Bracket (21 CFR§872.5470) .
- Product Codes DYW (Orthodontic Plastic Bracket)
- (Orthodontic Metal Bracket) EJF
- NJM (Orthodontic Ceramic Bracket)

### Device for Which Substantial Equivalence is Claimed:

- . Lava Digital Models, Marketed by 3M Unitek Class | Exempt Product Code: LMD (21CFR§892.2020)
- OrthoCAD iQ, Marketed by Cadent, Inc. ● Class II Study model described within K082207 DYW (Orthodontic Plastic Bracket, 21CFR§872.5470) Product Code: EJF (Orthodontic Metal Bracket, 21CFR§872.5410) NJM (Orthodontic Ceramic Bracket, 21CFR§872.5470)

#### Summary

.

#### Device Description

Insignia Digicast is a software product and service that creates digital models of patients' teeth, which are used primarily to record the status of a patients' dentition prior to treatment.

Clinicians may also use the digital model to support their diagnosis. The Insignia Digicast system scans a traditional impression, processes the scan, and electronically delivers a digital study model to the dental professional.

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KI 23118

The dental professional may view, measure, and analyze the Insignin Digicast three dimensional viewer software. The main analysis tools include TJ Moyers, Bolton analyses, ABO scoring, and Arch and Overbite/Overjet measurements.

There are no accessories or patient contacting components of Insignia Digicast.

# Indications for Use of the Device

Insignia Digicast is a computer aided system intended for use as an aid in orthodontic diagnostics for use by dental professionals trained in orthodontic treatment including radiographic analyses and diagnostics.

# Technological Characteristics Compared to Predicate

| Features | Insignia Digicast | OrthoCAD iQ | Lava Digital Model | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Insignia Digicast is a computer<br>aided system intended for use<br>as an aid in orthodontic<br>diagnostics for use by dental<br>professionals trained in<br>orthodontic treatment<br>including radiographic analyses<br>and diagnostics. | Ortho CAD iQ is a<br>computer-guided system<br>intended for use as an aid<br>in orthodontic treatment<br>planning for use by dental<br>professionals trained in<br>orthodontic treatment<br>including radiographic<br>analyses and treatment<br>planning. OrthoCAD iQ is<br>intended for use with<br>commercially-available<br>brackets and wires that<br>apply continuous gentle<br>force to reposition the<br>teeth. It also uses indirect<br>bonding trays to affix the<br>brackets in position. | Lava Digital Models is<br>a software product<br>that allows clinicians<br>to display and interact<br>with digital study<br>models for patient<br>consultations. Lava<br>Digital Models scans a<br>traditional impression,<br>processes the scan<br>and electronically<br>delivers the digital<br>study model to the<br>dental professional.<br>The dental<br>professional may<br>view, measure and<br>analyze the digital<br>study model. | | |
| Indications for<br>Use | | | | | |
| Features (cont.) | Insignia Digicast | OrthoCAD iQ | Lava Digital Model | | |
| Mode of Use | The Insignia Digicast system<br>scans a traditional impression,<br>processes the scan, and<br>electronically delivers a digital<br>study model to the dental<br>professional. | The OrthoCAD iQ system<br>scans a traditional<br>impression, processes the<br>scan, and electronically<br>delivers a digital study<br>model to the dental<br>professional. | The Lava Digital<br>Models system scans<br>a traditional<br>impression, processes<br>the scan, and<br>electronically delivers<br>a digital study model<br>to the dental<br>professional. | | |
| | Manufacturing<br>Method | A dental professional takes an<br>alginate or PVS impression of<br>the patient's teeth. The<br>impression is then scanned and<br>converted into a digital model.<br>This model is then uploaded for<br>use by the practitioner. | A dental professional<br>takes an alginate or PVS<br>impression of the<br>patient's teeth The<br>impression is then<br>scanned and converted<br>into a digital model. This<br>model is then uploaded<br>for use by the<br>practitioner. | A dental professional<br>takes an alginate or<br>PVS impression of the<br>patient's teeth The<br>impression is then<br>scanned and<br>converted into a<br>digital model. This<br>model is then<br>uploaded for use by<br>the practitioner. | |
| | | Analyses<br>Available | The following analyses are<br>available for use by the dental<br>practitioner: Bolton Analysis,<br>Tanaka-Johnston/Moyers<br>Analysis, Space Analysis, and<br>ABO Discrepancy Index Scoring. | The following analyses are<br>available for use by the<br>dental practitioner:<br>Bolton Analysis, Tanaka-<br>Johnston/Moyers<br>Analysis, Space Analysis,<br>and ABO Discrepancy<br>Index Scoring | Instantly obtain point-<br>to-point<br>measurements with<br>automatic calculations<br>and auto-sums<br>(Bolton analysis, arch<br>length, overbite and<br>overjet) |

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K123118

#### Non-Clinical Performance Data

This 510(k) submission includes data from bench testing used to evaluate the performance characteristics of Insignia Digicast compared to the predicate device, OrthoCAD iQ. The characteristics evaluated include, but were not limited to, teeth width, space, T-J Moyers, Bolton, Arch and Overbite/Overjet.

The Insignia Digicast software has been successfully validated to confirm the performance of the device.

#### Clinical Testing

Clinical testing has not been conducted on this product.

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## Conclusion

Based upon the similar technological/performance characteristics as compared to the predicate devices, and successful validation of the Insignia Digicast software, the performance of the Insignia Digicast is deemed to be substantially equivalent to the OrthoCAD iQ and Lava Digital Models. Additionally, there are no functional differences between the devices.

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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 stylized eagle-like symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

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

March 26, 2013

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

Re: K123118

Trade/Device Name: INSIGNIA DIGICAST Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW, NJM, EJF Dated: February 22, 2013 Received: February 25, 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 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. Ulmer -S
for

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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K123118

# Indications for Use

510(k) Number (if known):

Device Name: INSIGNIA DIGICAST

#### Indications For Use:

Insignia Digicast is a computer aided system intended for use as an aid in orthodontic diagnostics for use by dental professionals trained in orthodontic treatment including radiographic analyses and diagnostics.

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)

Andrew I. Steen Concurrence of Collige of Concerner ation (ODE)

> (Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K123118 510(k) Number:

004_Indications for Use - Page 2 of 2