ORTHOCAD IQ

K082207 · Cadent, Inc. · DYW · Oct 23, 2009 · Dental

Device Facts

• Record ID: K082207
• Device Name: ORTHOCAD IQ
• Applicant: Cadent, Inc.
• Product Code: DYW · Dental
• Decision Date: Oct 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2

Intended Use

OrthoCAD iQ is a computer-guided system intended for use as an aid in orthodontic treatment planning for use by dental professionals trained in orthodontic treatment including radiographic analyses and treatment planning. OrthoCAD iQ is intended for use with commercially-available brackets and wires that apply continuous gentle force to reposition the teeth. It also uses indirect bonding trays to affix the brackets in position.

Device Story

OrthoCAD iQ is a computer-guided orthodontic treatment planning system. Input consists of patient stone dental models. Software creates a 3D computer model of the patient's dentition; orthodontist uses this model to plan bracket placement for tooth repositioning. System produces customized indirect bonding trays containing brackets in the prescribed positions. Used in dental clinics by trained orthodontists. Orthodontist uses the bonding trays and commercially-available dental adhesive to affix brackets to patient teeth; wires are then applied to provide continuous force for tooth movement. Benefits include precise, planned bracket placement to facilitate orthodontic treatment.

Clinical Evidence

Clinical cases demonstrate the device functions as intended. Software verification and validation confirmed performance. Electrical safety testing performed. No specific clinical trial metrics (e.g., sensitivity, specificity) provided.

Technological Characteristics

Components: proprietary software, camera wand with light curing feature, customized indirect bonding trays, hard plastic case. Uses commercially-available metal, plastic, or ceramic brackets. Software calculates bracket positioning based on stone models and treatment plans. Connectivity/integration: uses stone models as input; produces physical trays.

Indications for Use

Indicated for orthodontic patients requiring tooth repositioning via brackets and wires; for use by trained dental professionals.

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

• Cadent Inc.'s OrthoCAD System
• Align Technologies, Inc.'s Invisalign System
• OraMetrix, Inc.'s SureSmile System

Submission Summary (Full Text)

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# K082207

### 510(k) SUMMARY

#### Cadent's OrthoCAD iQ

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

OCT 2 3 2009

Cadent. Inc. 640 Gotham Parkway Carlstadt, NJ 07072

Phone: [phone] Facsimile: [phone]

Contact Person: Edward J. Sitar

Date Prepared: October 21, 2009

#### Trade Name of Device

OrthoCAD iQ

#### Common or Usual Name of Device

Accessory to Orthodontic Brackets

# Classification Name, Classification Regulation, and Product Code(s)

Classification Name: Orthodontic Plastic Brackets

Classification Regulation: 21 C.F.R. 872.5470

Product Codes: DYW (Orthodontic Plastic Bracket), NJM (Orthodontic Ceramic Bracket), and EJF (Orthodontic Metal Bracket)

#### Predicate Devices

Cadent Inc.'s OrthoCAD System Align Technologies, Inc.'s Invisalign System OraMetrix, Inc.'s SureSmile System

#### Intended Use / Indications for Use

OrthoCAD iQ is a computer-guided system intended for use as an aid in orthodontic treatment planning for use by dental professionals trained in orthodontic treatment

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including radiographic analyses and treatment planning. OrthoCAD iQ is intended for use with commercially-available brackets and wires that apply continuous gentle force to reposition the teeth. It also uses indirect bonding trays to affix the brackets in position.

#### Technological Characteristics

The device consists of the following components and accessories: proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist, commercially-available metal, plastic, or ceramic brackets supplied by the orthodontist for that patient, a camera wand with a light curing feature, and customized indirect bonding trays containing the brackets, which are in a hard plastic case. The device does not include the adhesive that affixes the brackets to the teeth or the wires that are used with the brackets to form braces.

### Principles of Operation

OrthoCAD iQ's software creates a computer model of the patient's dentition based on a stone model. The orthodontist uses this computer model to determine the placement of dental brackets to achieve the intended repositioning of the teeth. Cadent, using the camera wand, manufactures an indirect bonding tray with the brackets in the positions prescribed by the orthodontist. The orthodontist uses the indirect bonding trays to place the brackets and a commercially-available dental adhesive to affix them to the patient's teeth.

#### Performance Data

Testing has demonstrated the electrical safety of the OrthoCAD iQ. Software verification and validation confirmed the performance of the device. Clinical cases demonstrate that it functions as intended.

### Substantial Equivalence

OrthoCAD iQ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. All of these devices create customized dental appliances based on computer models of the patient's pretreatment and post-treatment dentition. The minor technological differences between this device and its predicate devices raise no new issues of safety or effectiveness. Thus, the OrthoCAD iQ is substantially equivalent.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Cadent, Incorporated C/O Ms. Laurie Clarke King & Spalding, L.L.P. 1700 Pennsylvania Avenue, North West Washington, DC 20006-4706

OCT 2:3 2009

Re: K082207

Trade/Device Name: OrthoCAD iQ Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket 8Regulatory Class: II Product Code: DYW, NJM, EJF Dated: October 19, 2009 Received: October 19, 2009

Dear Ms. Clarke:

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 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. Clarke

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 (OS) 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

for

Susan Runner, D.D.S., M.A. Acting 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

510(k) Number (if known): K082207

Device Name: OrthoCAD iQ

Indications for Use:

OrthoCAD iQ is a computer-guided system intended for use as an aid in orthodontic treatment planning for use by dental professionals trained in orthodontic treatment including radiographic analyses and treatment planning. OrthoCAD iQ is intended for use with commercially-available brackets and wires that apply continuous gentle force to reposition the teeth. It also uses indirect bonding trays to affix the brackets in position.

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)

Keun Mickey for MSE
(Division Sign-Off)

Page 1 of 1 .

Division of Anesthesiology, General Hospital Infection Control, Dental Devices 082207

510(k) Number: