SCANORA 3D

K073350 · Soredex Palodex Group OY · MUH · Dec 19, 2007 · Dental

Device Facts

• Record ID: K073350
• Device Name: SCANORA 3D
• Applicant: Soredex Palodex Group OY
• Product Code: MUH · Dental
• Decision Date: Dec 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Scanora 3D is a dental cone beam computed tomography x-ray system intended to image teeth, jaw and TMJ areas of the skull. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by dentists and other qualified professionals.

Device Story

Scanora 3D is a dental cone beam CT system; captures 3D images of teeth, jaw, and TMJ using a pulsed conical x-ray beam and flat panel detector; optional CCD sensor captures panoramic images. Operated by dentists/qualified professionals in clinical settings. System rotates around patient head; generates 2D projections; software reconstructs 3D images for viewing. Clinicians use reconstructed images to visualize dental/maxillofacial anatomy, aiding diagnostic decision-making and treatment planning. Benefits include high-resolution 3D visualization of complex dental structures.

Clinical Evidence

Bench testing only. Non-clinical image quality comparison demonstrated that the Scanora 3D produces image quality similar to the predicate devices. The device complies with applicable FDA and FDA-recognized performance standards.

Technological Characteristics

Dental cone beam CT; pulsed conical x-ray beam; flat panel detector for 3D imaging; optional CCD sensor for panoramic imaging; system footprint similar to predicate devices; software-based 3D image reconstruction.

Indications for Use

Indicated for dental imaging of teeth, jaw, and TMJ areas of the skull in patients requiring diagnostic x-ray assessment. Operated by dentists and qualified professionals.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• Planmeca Promax 3D (K060328)
• i-CAT Scanner (K061284)

Submission Summary (Full Text)

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K073350
6-1 Pg 1 of 2

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## 510(k) Summarv

Date:

July 23, 2007

## Manufacturer:

SOREDEX. PaloDEx Group Ov P.O.Box 148 (Street address: Nahkelantie 160) FIN-04301 Tuusula, Finland

DEC 1 9 2007

Tel: [phone] Fax: [phone]

Contact person: Mr. Jouni Onnela, Tel [phone]

## United States Sales Representative (U.S. Designated agent):

INSTRUMENTARIUM DENTAL INC. 300 West Edgerton Ave. Milwaukee, WI 53207 -6025 Tel: [phone] Fax: [phone]

Contact Person: Mr. Frank Kashinski, Tel [phone]

### Trade name:

Scanora 3D

#### Common name:

Dental cone beam 3D x-ray system with dedicated panoramic imaging

### Classification name:

Extraoral source X-ray system (21 CFR 872.1800, product code MUH)

## Description:

Scanora 3D is a dental cone beam CT for imaging of teeth, jaw and TMJ areas of the skull. In CT mode it generates a pulsed conical x-ray beam during rotation around a patient's head and produces two dimensional images on a flat panel detector. Three dimensional images are then reconstructed and viewed with software. In panoramic mode panoramic and TMJ images can be taken in the classical way on a separate CCD detector.

#### Intended use:

Scanora 3D is a dental cone beam computed tomography x-ray system intended to image teeth, jaw and TMJ areas of the skull. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by dentists and other qualified professionals.

www.soredex.com

SOREDEX PaloDEx Group Oy, Nahkelantie 160 P.O. Box 148, 04301 Tuusula, FINLAND • TEL [phone] FAX [phone] · [e-mail] · www.soredex.com · VAT FI19810468

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## Substantial Equivalence:

We consider Scanora 3D is similar in design, composition and function to the following predicate devices introduced into commercial distribution after May 28, 1976:

Planmeca Promax 3D (K060328, MUH) i-CAT Scanner (K061284, MUH)

The assesment of characteristics and performance supports substantial equivalence.

## Assesment of characteristics and performance:

Scanora 3D has the same technological characteristics as the predicate devices. It has similar x-ray generation, detectors, imaging technique and system footprint to the predicate devices. A non-clinical image quality comparison demonstrated Scanora 3D produces similar image quality to the predicate device. Scanora 3D complies with applicable FDA and FDA recognized performance standards.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SOREDEX, PaloDEx Group Oy % Mr. Daniel W. Lehtonen Senior Staff Engineer-Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K073350

Trade/Device Name: Scanora 3D Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: MUH and JAK Dated: November 27, 2007 Received: November 29, 2007

#### Dear Mr. Lehtonen:

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.

DEC 1 9 2007

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known):

Device Name: Scanora 3D

Indications for Use:

Scanora 3D is a dental cone beam computed tomography x-ray system intended to image teeth, jaw and TMJ areas of the skull. A flat panel detector is nevel to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by dentists and other qualified professionals.

Prescription Use (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)

Tony M. Whan

on Sian-Off) ivision of Reproductive, Abdominal and adiological Devices

70(k) Number P615350

www.soredex.com

SOREDEX PaloDEx Group Oy, Nahkelantie 160 P.O. Box 148, 04301 Tuusula, FINLAND • TEL [phone] FAX [phone] · [e-mail] · www.soredex.com · VAT FI19810468