DEGOTZEN SYNCHRO

K021245 · The Gotzen Group, Inc. · EHD · May 3, 2002 · Dental

Device Facts

• Record ID: K021245
• Device Name: DEGOTZEN SYNCHRO
• Applicant: The Gotzen Group, Inc.
• Product Code: EHD · Dental
• Decision Date: May 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The de Gotzen "synchro" Intraoral Dental X-Ray System is an Extraoral Source X-Ray System, intended to be used for dental radiographic examinations and diagnosis of the teeth, jaw, and oral structures.

Device Story

The de Gotzen synchro is an extraoral dental X-ray system used in clinical settings by dental professionals. It consists of an X-ray tubehead, yoke, articulating arm, wall mount, and an electronic control timer. The system generates X-rays at a fixed 70kVp and 8mA. Operators select exposure times (0.08 to 3.2 seconds) via the control timer switchpads. The device uses 8" or 12" collimating cones to direct the X-ray beam toward the patient's oral region for intraoral imaging. The output is an X-ray beam used to capture dental radiographs, which the clinician interprets to diagnose conditions of the teeth, jaw, and oral structures. The system is designed to be compatible with both film and digital imaging receptors.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technical performance comparisons, including tube voltage, current, focal spot size, and leakage radiation measurements.

Technological Characteristics

Extraoral dental X-ray system; 70kVp fixed voltage; 8mA fixed current; 0.7 x 0.7mm focal spot; 8"/12" collimating cones; >2.0mm Al filtration; AC generator; electronic timer with 17-step exposure selection (0.08-3.2s); wall-mounted articulating arm; compatible with film and digital receptors.

Indications for Use

Indicated for dental radiographic examinations and diagnosis of teeth, jaw, and oral structures in patients requiring intraoral 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

• Aztech 70 (K984524)
• Gendex Gx770 (K935046)
• Sirona Heliodent Vario (K000672)
• Dent-x image X-70 Plus (K000551)
• Belmont Belray 096 (K963699)

Submission Summary (Full Text)

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MAY 0-3 2002

<021245
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## 510K Summary Statement for the de Gotzen "synchro" Intraoral Dental X-Ray System.

### General Information

| Manufacturer: | de Gotzen S.r.l<br>Via Roma 45<br>21057 OLIGIATE OLONA (Varese) Italy |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------|
| Establishment Registration: | |
| Telephone: | (011) 39 0331 376760 |
| Fax Line: | (011) 39 0331 376763 |
| Contact Person: | Antonella GASPARRI, International Compliance Office |
| Submitter: | The Gotzen Group, Inc., (dba) TG Group, Inc. Canada<br>3505 Laird Road, Unit #7<br>Mississauga, Ontario L5L 5Y7 |
| Establishment Registration: | #9615032 & Health Canada Establishment: # 692 |
| Telephone: | [phone] (Watts Line) |
| Fax Line: | [phone] |
| Contact Person: | Wayne Lebeau, President |
| USA Office: | TG Group USA, LLC<br>30 Alden Terrace<br>Flanders, NJ 07836 |
| Telephone: | [phone] |
| Fax Line: | [phone] |
| Contact Person: | Donald R. Hill, VP Sales & Marketing<br>USA FDA Liaison |
| Summary Preparation Date: | January 24, 2002 |

## Name and Classification

Device Name:

de Gotzen synchro Intraoral Dental X-Ray System 90EHD - Unit, X-Ray, Extraoral with Timer Dental

## Primary Classification Name: Classification Panel:

#### Predicate Devices

The de Gotzen synchro Intraoral Dental x-ray System is substantially equivalent to the following previously cleared and currently marketed devices.

Aztech 70 Gendex Gx770 Sirona Heliodent Vario Dent-x image X-70 Plus Belmont Belray 096

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#### Product Description

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The de Gotzen synchro Intraoral Dental X-Ray System is comprised of the following main components:

- X-Ray tubehead and yoke .
- . Articulating arm
- Horizontal arm, standard length ●
- Wall Mount
- Electronic control timer (which may be mounted remotely) .
- 8" and 12" Collimating cones .

Optional components:

- . Horizontal arm, short length
- Horizontal arm, long length .
- . Rectangular collimating cone

The power supply (Timer) is regulated to provide a fixed 70kVp, and the x-ray target current is fixed at 8ma. Predefined exposure times may be selected directly through the control timer switchpads. The range of exposure time is 0.08 through 3.2 seconds

#### Intended Use:

The de Gotzen synchro Intraoral Dental X-Ray System is an Extraoral source of x-rays for Intraoral images in dental radiography.

#### Comparison of Technological Characteristics:

Rationale for Substantial Equivalence.

The de Gotzen synchro Intraoral Dental X-Ray System shares the same indications for use, similar materials, design, operational, and functional features and therefore is Substantially Equivalent to the predicate devices listed in this summary.

Table comparing performance of de Gotzen synchro with predicate devices:

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| Specifications | Aztech 70 | Gendex Gx770 | Sirona Heliodent Vario | Dent-x Image x-70 Plus | Belmont Belray 096 | de Gotzen synchro |
|-----------------------------------------------------|-------------------------|--------------------------|--------------------------------------------------------|--------------------------------|-----------------------|-------------------------------------------------------|
| Registration Number | K984524 | K935046 | K000672 | K000551 | K963699 | |
| Line Requirements | 110V-120V 50Hz-<br>60Hz | 110V - 130V 60Hz | 100V/110V/120V, 11A<br>220V/230V/240V, 6A<br>50Hz/60Hz | 110V/220V, 50Hz/60Hz | 108V - 132V 50Hz.60Hz | 220V/230V/240V, 8A<br>110V - 120V 5.5A<br>50hZ - 60hZ |
| Generator Type | AC | AC | AC Single Pulse | AC | AC | AC |
| Tube Voltage | 65 kV | 70 kV | 70 kV | 70 kV | 70 kV | 70 kV |
| Tube Current | 8 mA | 7 mA | 7mA | 8 mA | 10 mA | 8 mA |
| Exposure Time Selection | 0.03 -3.0 Sec | 3-99 impulses (28 Steps) | 0.03 - 3.2 Sec | 0.08- 3.2 Sec | 0.02 -3.0 Sec | 0.08- 3.2 Sec. 17 Steps |
| Focal Spot | 0.7 | 0.6mm | 0.8mm | 0.7 X 0.7 mm | 0.8 X 0.8mm | 0.7 X 0.7mm |
| Focal Length | 8in/12in | 8in/12in | 8in/12in | 8in/12in | 8in/12in | 8in/12in |
| Total Filtration in X-ray tube unit | Unknown | Unknown | >2 mm Al | >2.5 mm Al | >2.1 mm Al | >2.0 mm Al |
| | | | | 28 mR/hr at 1m from focal spot | | Less than 2.5 mGy/h |
| Leakage Radiation Compatiabel with Film and Digital | Yes | Yes | Yes | Yes | Yes | Yes |

:

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### Conclusion

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The deGotzen synchro Intraoral Dental X-Ray System was found to be /is substantially Equivalent to the predicate devices; the Aztech 70, Gendex Gx770, Siron Heliodent Vario, Dent-x image x-70, and Belmont Belray 096. The de Gotzen synchro shares the same indications for use, similar materials, design, operational, and functional features as the current marketed predicate devices. It has been shown to be safe and effective when used as labeled.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is a stylized image of an eagle.

#### Public Health Service

**MAY 03 2002**

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Gotzen Group, Inc. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K021245 Trade/Device Name: deGotzen synchro Intraoral X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: April 18, 2002 Received: April 19, 2002

Dear Mr. Mosenkis:

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.

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.

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This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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

Enclosure

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# XI. INDICATIONS FOR USE STATEMENT

Applicant: de Gotzen S.r.L.

510(k) Number (if known): k_02/245

Device Name: de Gotzen "synchro" Intraoral Dental X-Ray System

Indications for Use: The de Gotzen "synchro" Intraoral Dental X-Ray System is an Extraoral Source X-Ray System, intended to be used for dental radiographic examinations and diagnosis of the teeth, jaw, and oral structures.

(Please do not write below this line – Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: underline;">✓</span> | OR | Over-The-Counter Use | <span style="text-decoration: underline;">_____</span> |
|----------------------|----------------------------------------------------|----|----------------------|--------------------------------------------------------|
| (Per 21 CFR 801.109) | | | | |


| (Division Sign-Off) | |
|--------------------------------------|---------|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K021245 |

| (Division Sign-Off) |
|------------------------------------------|
| Division of Reproductive, Abdominal, ENT |
| And Radiological Devices |

510K Number___________________________________________________________________________________________________________________________________________________________________