ENDOS DC

K030634 · Villa Sistemi Medicali S.P.A. · EHD · Jul 21, 2003 · Dental

Device Facts

• Record ID: K030634
• Device Name: ENDOS DC
• Applicant: Villa Sistemi Medicali S.P.A.
• Product Code: EHD · Dental
• Decision Date: Jul 21, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

Device Story

ENDOS DC is an extraoral dental X-ray system used by dental professionals in clinical settings. It generates X-ray radiation to produce radiographic images of teeth for diagnostic purposes. The device utilizes a high-frequency generator to produce X-rays, with exposure parameters (time) managed by an integrated microprocessor-controlled system. Operators use a 'dead man' command switch to initiate exposure, accompanied by acoustic and visual signaling for safety. The system is designed for dental radiographic examination and diagnosis of dental diseases. By providing high-quality imaging, it assists clinicians in identifying dental pathologies, thereby facilitating appropriate treatment planning and improving patient outcomes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

High-frequency X-ray generator; 65 kVp output; 4-5 mA tube current; 0.7 mm focal spot (IEC 336); 19° anode inclination; >2.0 mm Al total filtration; microprocessor-controlled exposure timing (0.010-2 sec); dead man switch; acoustic/visual signaling. Operates at 120V.

Indications for Use

Indicated for dental radiographic examination and diagnosis of diseases of the teeth in patients requiring extraoral X-ray imaging. Prescription only.

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

• GENDEX DENTSPLY model 765DC (K992610)

Submission Summary (Full Text)

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K030634

## Appendix 1 - 510 (k) SUMMARY

# 510(k) summary for STRATO X

#### Identification

| Applicant | Villa Sistemi Medicali S.p.A.<br>Via delle Azalee 3,<br>20090 BUCCINASCO - Milan- Italy<br>Registration Number: 8021091 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | dr. Roberto Daglio – QA Director |
| Telephone (applicant) | + 39 02 48859233 |
| Designated Agent<br>in the US | Andrew Hryndza<br>Del Medical<br>11550 West King Street<br>Franklin Park<br>Illinois 60131<br>Tel. [phone] FAX. [phone] |
| Manufacturing site | Villa Sistemi Medicali S.p.A.<br>Via delle Azalee 3,<br>20090 BUCCINASCO - Milan - Italy |

Trade name: ENDOS DC

Common name: ENDOS DC

Classification name: according to 21 CFR 872-1800, ENDOS DC is in Class II.

Substantial equivalent device: the ENDOS DC is defined as Substantially Equivalent (SE) to the GENDEX DENTSPLY model 765DC. The predicate device has been approved by FDA and has 510(k) approval number K992610

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| | ENDOS DC | GENDEX 765 DC |
|---------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Intended use | extra oral source X-ray<br>system for dental<br>radiographic examination<br>of the teeth | extra oral source X-ray<br>system for dental<br>radiographic examination |
| High Voltage value | 65 kVp+/-5% | 65 kVp +/- 3kV |
| Tube current | 4-5 mA +/-5% | 7 mA +/- 5% |
| Focal spot size | 0.7 mm (IEC 336) | 0.4 mm (IEC 336) |
| Anode inclination | 19° | 12.5° |
| Total filtration | > 2.0 mm Al | 2.0 mm Al |
| HVL | > 1.5 mm Al | 2.0 mm Al |
| H.V. generator: | High frequency | High frequency |
| X-Ray exposure<br>time control | Automatic - pre-<br>programmed<br>Microprocessor<br>Controlled | Automatic - pre-<br>programmed<br>Microprocessor<br>Controlled |
| X-Ray exposure<br>timing | 0.010 sec to 2 sec | 0.020 sec to 2 sec |
| Electrical<br>characteristics | 120 V<br>4.5 impulsive A max | 120 V<br>5 impulsive A max |
| Focus film distance | > 20 cm<br>or > 30cm | > 20 cm<br>or > 30cm |
| Leakage radiation | < 25 mR/h at 1 meter from<br>focus | < 28 mR/h at 1 meter from<br>focus |
| X-ray beam<br>dimension at 20cm | < 6cm | < 6cm |
| Safety features | Dead man command | Dead man command |
| Signaling devices | Acustic and visual signal | Acustic and visual signal |

The following table compares the ENDOS DC V with the predicate device

### Indication for use.

The indication for use of the ENDOS DC is: : extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

510(k) ENDOS DC

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a caduceus, a traditional symbol of medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2003

Mr. Roberto Daglio QA Director Villa Sistemi Medicali via Azalee 3 20090 Buccinasco, Milan ITALY

Re: K030634

Trade/Device Name: ENDOS DC Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: May 7, 2003 Received: May 9, 2003

Dear Mr. Daglio:

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 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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

Nancv 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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#### Indication for use Statement 4.1.

510(k) Number: 长 030634

Device Name: ENDOS DC

The indication for use of the ENDOS DC is: : extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

used as:
prescription only: \$\checkmark\$*_*_

David A. Seppanen

IVISION Sion-