(40 days)
Not Found
No
The description focuses on the hardware components and basic microprocessor control for exposure timing, with no mention of AI or ML for image processing, diagnosis, or other functions.
No
The device is described as an X-ray source system for diagnostic imaging, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures."
No
The device description clearly outlines hardware components such as an X-Ray source, generator, tube, timer, and adjustable arm, indicating it is a physical medical device system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HELIODENT Plus Function: The HELIODENT Plus is an extraoral X-Ray source system. It generates X-rays that pass through the patient's body to create an image. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures." This is an imaging procedure, not an in vitro test.
Therefore, based on the provided information, the HELIODENT Plus is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HELIODENT Plus is an extraoral X-Ray source System intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Product codes (comma separated list FDA assigned to the subject device)
EHD
Device Description
The HELIODENT Plus is an extraoral source dental X-ray system intended for intraoral imaging. X-rays are produced using a multi-pulse generator with a selectable tube voltage of 60 and 70 kV and a tube current of 7 mA. A microprocessar-controlled timer allows for consistent and accurate exposure control, and an adjustable arm allows for easy positioning. The system can be used either with conventional film or a digital imaging system. Basic settings of exposure times are programmed and may be selected by buttons.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
teeth, jaw, and oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
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.(b)
Classification. Class II.
0
510(k) Summary for Sirona Dental Systems HELIODENT Plus
DEC 2 3 2008
1. SPONSOR
Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany
Contact Person: Fritz Kolle 49 6251 16 32 94 Telephone:
Date Prepared: August 25, 2008
2. DEVICE NAME
| Proprietary Name: | HELIODENT Plus |
|---|---|
| Common/Usual Name: | Unit, X-Ray, Extraoral with Timer |
| Classification Names: | Extraoral source x-ray system |
3. PREDICATE DEVICE
Sirona HELIODENT DS (K960819) and Progeny Preva Dental X-Ray System (K043092)
4. INTENDED USE
The HELIODENT Plus is an extraoral X-Ray source System intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
ડ. DEVICE DESCRIPTION
The HELIODENT Plus is an extraoral source dental X-ray system intended for intraoral imaging. X-rays are produced using a multi-pulse generator with a selectable tube voltage of 60 and 70 kV and a tube current of 7 mA. A microprocessar-controlled timer allows for consistent and accurate exposure control,
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and an adjustable arm allows for easy positioning. The system can be used either with conventional film or a digital imaging system. Basic settings of exposure times are programmed and may be selected by buttons.
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
Based on the comparison of intended use, construction, and technical features, Sirona Dental Systems believes that the HELIODENT Plus is substantially equivalent to the HELIODENT DS (K960819) and Progeny Preva Dental X-Ray System (K043092). The proposed and predicate devices have the same intended use and principles of operation. The overall designs of the proposed and predicate devices are similar. Technical specifications of the HELIODENT Plus are the same or very similar to those of the predicate devices. All devices generate the X-ray radiation using a multipulse generator source. The characteristics of the X-ray tube, including tube voltage, tube current, focal spot, focal length and X-ray filtration, and the X-ray exposure times are all within equivalent ranges.
August 25, 2008
2
Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an emblem of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the top and left side of the circle. The eagle emblem is stylized with three curved lines representing the wings and a wavy line representing the body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sirona Dental Systems GmbH % Mr. Olaf Teichert Third Party Reviewer TUV SUD America, Inc. 1775 Old Hwy. 8 N.W., Suite 104 NEW BRIGHTON MN 55112-1891
DEC 2 3 2008
Re: K083344
Trade/Device Name: HELIODENT Plus Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: December 9, 2008 Received: December 11, 2008
Dear Mr. Teichert:
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 intersted 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 (c. The general controls provisions of the Act include requirements for annual registration, l'isting of devices, good manufacturing practice, labeling, and prohibitions against misburanding 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 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 (2) CFR Party of 1 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 10(t) 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (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 Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Pro 210-2 (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 (800) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/suport/index.html
Sincerely yours.
loque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
ਾਂ
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510(k) Number (if known): Ko83344
Device Name: _________ HELIODENT Plus
Indications for Use:
The HELIODENT Plus is an extraoral X-Ray source System intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrenge of CDRH, Office of Device Evaluation (ODE)
Hozui Do Nhang
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Sirona Dental Systems 510(k) HELIODENT Plus
(
August 25, 2008
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