EXPLOR-X 70

K991310 · Villa Sistemi Medicali S.P.A. · EHD · Jun 18, 1999 · Dental

Device Facts

• Record ID: K991310
• Device Name: EXPLOR-X 70
• Applicant: Villa Sistemi Medicali S.P.A.
• Product Code: EHD · Dental
• Decision Date: Jun 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Explor X 70 AP TIME X (the Explor X 70 with the AP TIME X timer) is intended for the examination and diagnosis of diseases related to the dental radiological application and use of an extra oral source x-ray system commonly referred to as intraoral x-ray equipment.

Device Story

Explor-X 70 is an intraoral X-ray system equipped with an AP Time X timer. Device functions as an extra-oral source X-ray system for dental imaging. Operated by dental professionals in clinical settings to capture radiographic images for diagnostic purposes. Timer controls exposure duration to ensure appropriate radiation delivery. Output consists of X-ray radiation directed at dental structures to produce diagnostic images. Clinical benefit includes visualization of dental anatomy for disease detection and treatment planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intraoral X-ray system; includes AP Time X timer for exposure control. Class II device (21 CFR 872.1800).

Indications for Use

Indicated for dental patients requiring extra-oral or intra-oral radiographic examination and diagnosis of dental diseases.

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

• Explor-X 70 with Diamatic AP timer

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a logo for Villa Sistemi Medicali. The logo consists of a stylized letter "V" above the words "VILLA" and "SISTEMI MEDICALI", which are stacked on top of each other. The logo is in black and white, with the letter "V" and the text being white against a black background.

K 991310

## Annex 1 - 510 (k) SUMMARY

# 510(k) summary for Explor-X 70

#### Identification

| Applicant | Villa Sistemi Medicali S.p.A.<br>Via delle Azalee 3,<br>20090 BUCCINASCO - Milan- Italy |
|-------------------------------|------------------------------------------------------------------------------------------|
| Contact Person | dr. Francesco Attuati |
| Telephone (applicant) | + 39 2 488591 |
| Official Correspondent | Chicago X-Ray Systems, Inc.<br>Wheeling, IL 60090 |
| Contact Person | Al SOSA - President |
| Telephone<br>(contact person) | 847 - 459 3889 |
| Manufacturing site | Villa Sistemi Medicali S.p.A.<br>Via delle Azalee 3,<br>20090 BUCCINASCO - Milan - Italy |

Trade name: Explor-X 70

Common name: Explor-X 70 with AP Time X timer

Classification name: according to 21 CFR 872-1800, Explor-X 70 device is in Class II.

Substantial equivalent device: the proposed equipment is defined as Substantially Equivalent (SE) to the Explor-X 70 with Diamatic AP timer. This assumption is based on the comparison table contained on the following page.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present.

Image /page/1/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 perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 18 1999

Villa Sistemi Medicali S.P.A. C/o Chicago X-Ray Systems, Inc. Attn: Al Sosa 251 E. Dundee Road Wheeling, IL 60090

Re:

510(k) 991310 Trade Name: Explor-X-70 with AP Time X timer Dated: February 23, 1999 Received: April 16, 1999. Classification: II 21CFR 872.1800 Product Code: 90 EHD

Dear Mr.Sosa:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will vertly such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

| CC: | HFZ-401 | DMC |
|-----|----------|--------------|
| | HFZ-404 | 510(k) Staff |
| | HFZ-D.O. | Division |

.

:

:

·

{3}------------------------------------------------

Page 1 of 1

#### 510(k) NUMBER (IF KNOWN): K991310 DEVICE NAME: EXPLOR X 70 AP TIME X INDICATIONS FOR USE:

The Explor X 70 AP TIME X (the Explor X 70 with the AP TIME X timer) is intended The Explor A 70 AC THIO II (Miassion and diagnosis of deseases related to the for the demail rablog applie exammistion and singless use of an extra oral source x-ray system commonly referred to as intraoral x-ray equipment.

### (PLEASE DO NOT WRITE BELOW - CONTINUE ON ANOTHER PAGE IF NEEDED.)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|------------------------------------------------------------------------|----|--------------------------|
| Prescription Use | OR | Over-The-Counter-Use |
| (Per 21 CFR 801.109) <span style="text-decoration: overline;">✓</span> | | (Optional Format 1-2-96) |

| (Division Sign-Off) | <img alt="Signature" src="signature.png"/> |
|--------------------------------------------------------------------|--------------------------------------------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K991310 |