SNAPSHOT

K081925 · Instrumentarium Dental, Palodex Group OY · MUH · Sep 2, 2008 · Dental

Device Facts

• Record ID: K081925
• Device Name: SNAPSHOT
• Applicant: Instrumentarium Dental, Palodex Group OY
• Product Code: MUH · Dental
• Decision Date: Sep 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

Snapshot is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

Device Story

Snapshot is a digital intraoral sensor system used in dental clinics by dentists or qualified professionals. It captures intraoral dental x-ray images when used with general intraoral X-ray units. The system consists of a CMOS sensor (available in two sizes), sensor holders, hygienic covers, and workstation software. The sensor connects to a workstation PC via a USB 2.0 high-speed cable, which also serves as the power source. Captured images are transferred to the PC for display and diagnostic review by the clinician. The device facilitates dental diagnosis by providing digital radiographs of dentition, jaws, and oral structures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Digital intraoral sensor system using CMOS sensor technology. Connectivity via USB 2.0 for data transfer and power. System includes sensor, workstation software, holders, and hygienic covers. Form factor includes two sensor sizes.

Indications for Use

Indicated for dentists and qualified professionals to produce diagnostic x-ray radiographs of dentition, jaws, and oral structures in patients requiring dental imaging.

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

• Sigma M (K063837)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for INSTRUMENTARIUM. The logo consists of a stylized lowercase "i" inside of a circle on the left, followed by the word "INSTRUMENTARIUM" in all caps. The font is a simple sans-serif typeface.

K081925

SEP - 2 2008

# 510(k) Summary

#### Date:

June 26, 2008

#### Manufacturer:

Instrumentarium Dental, PaloDEx Group Oy Nahkelantie 160 04300 Tuusula, Finland

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:

Snapshot

#### Common name:

Digital intraoral sensor system.

#### Classification name:

System, x-ray, extraoral source, digital (21 CFR 872.1800, product code MUH)

#### Predicate device:

.

Sigma M, K063837, MUH

#### Description:

Snapshot is a digital intraoral sensor system that can be connected to a workstation PC via USB connection. The essential function and purpose of the system in a dental clinic is to capture intraoral digital dental x-ray images. The system can be used with general intraoral X-ray units.

Snapshot utilizes existing designs and share parts with the predicate Sigma M sensor. The sensor is the same CMOS sensor as that of the predicate device. USB 2.0 High speed connection is used for image transfer to a PC.

The basic system consists of

- Sensor, which is available in two sizes
- . Workstation software
- . Sensor holders and hygienic covers

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Image /page/1/Picture/0 description: The image shows the word "INSTRUMENTARIUM" next to a logo. The logo is a stylized letter "i" inside of a circle. The text is in all caps and appears to be a sans-serif font.

## Intended use:

Snapshot is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

## Technological characteristics:

Snapshot has the same sensor design and materials as the predicate device. The terminal unit between the sensor and a PC is smaller in size than that of the predicate device. The energy source is USB from the PC compared to the rechargeable battery of the predicate device. USB 2.0 High speed connection is used for image transfer to the PC compared to wireless image transfer (WLAN) of the predicate device.

## Substantial Equivalence:

We consider Snapshot is similar in design, composition and function to the predicate device Sigma M, K063837, MUH.

The comparison of characteristics also by following the guidance document "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" supports substantial equivalence.

As conclusion Snapshot is as safe, as effective, and performs as well as or better than the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2008

Mr. Jouni Onnela Regulatory Manager Instrumentarium Dental, PaloDEx Group Oy Nahkelantie 160 Tuusula, 00430 FINLAND

Re: K081925

Trade/Device Name: Snapshot Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 26, 2008 Received: July 7, 2008

#### Dear Mr. Onnela:

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 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 I toase oc actived that I be results at your device complies with other requirements of the Act that IDA has inder a decornments administered by other Federal agencies. You must or any I catal statutios and regarations, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of K Part 807), incenter (21 (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) I mis lotter with and in your e finding of substantial equivalence of your device to a legally promation notinetation " 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/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C. Brogdon

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Instrumentarium. The logo consists of a stylized letter "i" inside of a circle on the left, followed by the word "INSTRUMENTARIUM" in a simple, sans-serif font. The logo is black and white.

# Indications for Use

08/925 510(k) Number (if known):

Device Name: Snapshot

Indications for Use:

Snapshot is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

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)

Division

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number