Who is the manufacturer of Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph?

Fona S.R.L filed the 510(k) submission for Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph (K213579).

What is the FDA product code for Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph?

OAS. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

K213579 · Fona S.R.L · OAS · Mar 2, 2022 · Radiology

Device Facts

Record ID	K213579
Device Name	Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
Applicant	Fona S.R.L
Product Code	OAS · Radiology
Decision Date	Mar 2, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	Pediatric

Intended Use

Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry. Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations. Stellaris 3D: Extraoral source dental X-ray system intended to perform 3D and panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry. Stellaris 3D Ceph: Extraoral source dental X-ray system intended to perform 3D, panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.

Device Story

Extraoral dental X-ray system; performs panoramic, cephalometric, and 3D (CBCT) imaging. Rotating arm with motor-driven rototranslatory movements follows patient morphology; X-ray generator produces beam based on user-selected technique factors; CMOS or CsI flat panel sensors capture X-rays, converting them to electrical signals. Operated by dental professionals in clinical settings; patient head stabilized via bite blocks, chin rests, and temple supports; exposure controlled by manual hand-switch with dead-man functionality. Ethernet connection transmits data to external PC for image acquisition, processing, and storage using third-party software (e.g., OrisWin DG Suite). Provides diagnostic images for dento-maxillo-facial region; aids surgeons, dentists, and radiologists in diagnosis and treatment planning.

Clinical Evidence

No formal clinical trial; clinical evidence consists of an evaluation of sample clinical images by the manufacturer to confirm diagnostic adequacy per FDA guidance for solid-state digital X-ray panels.

Technological Characteristics

Extraoral X-ray system; CMOS/CsI flat panel sensors; high-frequency multi-pulse generator (ripple ≤4%); 0.5 focal spot (IEC 60336); 60-86 kV tube voltage; 2.5-10 mA tube current. Class I laser aiming lights (650 nm). Ethernet connectivity. Biocompatible patient-contact materials (ISO 10993-1). Standards: IEC 60601-1 (Safety), IEC 60601-1-2 (EMC), IEC 60601-1-3 (Radiation), EN 60601-2-63 (Performance), EN 62304 (Software).

Indications for Use

Indicated for general and pediatric dentistry patients requiring extraoral dental X-ray imaging, including panoramic, cephalometric, and 3D dento-maxillo-facial exams, and carpal images for clinical investigations.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

ORTHOPHOS SL (K150217)

Reference Devices

FONA XPan DG (K161131)
XPan DG Plus (K161131)
ART Plus (K161131)
ART Plus C (K161131)

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K161131 — FONA Pan/Ceph · Fona S.R.L · Nov 3, 2016
K142247 — RAYSCAN A-EXPERT 3D · Ray Co., Ltd. · Apr 17, 2015
K232287 — RAYSCAN a-Expert3D · Ray Co., Ltd. · Aug 31, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ March 2, 2022 Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is an emblem representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, and the words "U.S. FOOD & DRUG" are stacked above the word "ADMINISTRATION". FONA S.r.l % Krupa Srivastava RA Consultant Via G. Galilei 11 Assago, Milan 20057 ITALY Re: K213579 Trade/Device Name: Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: January 25, 2022 Received: January 14, 2022 #### Dear Krupa Srivastava: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Laurel Burk Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213579 Device Name Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph #### Indications for Use (Describe) Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry. Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations. Stellaris 3D: Extraoral source dental X-ray system intended to perform 3D and panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry. Stellaris 3D Ceph: Extraoral source dental X-ray system intended to perform 3D, panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for "FONA". The word "FONA" is written in large, bold, gray letters. Above the word "FONA" is a curved yellow line. Below the word "FONA" is the phrase "CLOSER TO YOU" written in smaller, gray letters. #### 510(k) SUMMARY K213975 | Date Prepared: | January 11, 2022 | |---------------------------|------------------------------------------------------------------------| | Submitters Information | | | Name | FONA s.r.l. | | Address | Via G.Galilei 11 20057 Assago (MI), Italy | | Contact Person | Luigi Germanò | | Contact Telephone | +39 0245712171 | | Device Information | | | Device/ Trade Name | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | | Common Name | X-Ray, Tomography, Computed, Dental | | Classification Name | Computed Tomography X-ray system | | Classification Regulation | 21 CFR 892.1750 - Computed Tomography X-ray system | | Product code | OAS | #### Predicate Devices: The following legally marketed predicate devices have been chosen for the determination of substantial equivalence: | Primary Predicate Device Trade Name | ORTHOPHOS SL | |----------------------------------------|----------------------------------| | 510(k) Number | K150217 | | Classification Name | Computed Tomography X-ray system | | Classification Regulation | 21 CFR 892.1750 | | Product code | OAS | Traditional 510(k)- Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph FONA S.r.l {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for FONA. The word "FONA" is written in large, bold, gray letters. Below the word "FONA" are the words "CLOSER TO YOU" in smaller, gray letters. Above the word "FONA" is a curved yellow line. Reference Device | Trade Name | FONA XPan DG, XPan DG Plus, ART Plus & ART Plus C | |---------------------------|---------------------------------------------------| | 510(k) Number | K161131 | | Classification Name | Extraoral Source X-Ray System | | Classification Regulation | 21 CFR 872.1800 | | Product code | MUH | ## Indications for use Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillofacial region and in subregions, for general and pediatric dentistry. Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subreqions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations. Stellaris 3D: Extraoral source dental X-ray system intended to perform 3D and panoramic exams with production of diagnostic images in the dentomaxillo-facial region and in subregions, for general and pediatric dentistry. Stellaris 3D Ceph: Extraoral source dental X-ray system intended to perform 3D, panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations. ## Device Description: Stellaris 3D is a dental X-ray system for Panoramic and Cone Beam Computed Tomography (CBCT) which allows to perform all the radiographic projections, both 2D and 3D, of most interest for the dentist, the surgeon and the maxilla-facial radiologist. In addition to the functions of Panoramic and 3D radiography, Stellaris 3D Ceph also allows to perform One-Shot Cephalometric radiographs. Stellaris 2D is a dental X-ray system for Panoramic which allows to perform all the radiographic projections of most interest for the dentist, the surgeon and the maxilla-facial radiologist. In addition to the functions of Panoramic, Stellaris 2D Ceph also allows to perform One-Shot Cephalometric radiographs. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for FONA. The word "FONA" is written in large, gray, sans-serif letters. Above the word "FONA" is a yellow swoosh. Below the word "FONA" are the words "CLOSER TO YOU" in smaller, gray, sans-serif letters. Except for the panoramic acquisition sensor, the remaining mechanical, electrical and software characteristics of Stellaris 2D are exactly identical to those of Stellaris 3D. The control panel interface on the unit provides a complete control of the operation and for the setting of the desired technique factors. Class I LASER aiming lights support positioning of patient's head, which is stabilized through the use of bite blocks, chin rest, and, if required, temple supports. The user controls the exposure using a manual hand-switch, implementing the dead man functionality. An Ethernet connection cable allows the FONA Stellaris devices to interface with a computer for image acquisition, processing and storage. | | Stellaris 3D | Stellaris 3D Ceph | Stellaris 2D | Stellaris 2D Ceph | |---------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------| | X-ray Programs | Pan: 9 programs 3D: 23 programs Ceph: N/A | Pan: 9 programs 3D: 23 programs Ceph: 4 programs | Pan: 9 programs 3D: N/A Ceph: N/A | Pan: 9 programs 3D: N/A Ceph:4 programs | | Exposure Times | Pan: max 14.2 s 3D: max 16.9 s Ceph: N/A | Pan: max 14.2 s 3D: max 16.9 s Ceph: max 4 s | Pan: max 14.2 s 3D: N/A Ceph: N/A | Pan: max 14.2 s 3D: N/A Ceph: max 4 s | | Sensor Technology | Pan/3D: CMOS sensor 15x15 cm Ceph: N/A | Pan/3D: CMOS sensor 15x15 cm Ceph: Csl flat panel 24.4x30.7 cm | Pan: CMOS sensor 15x0.6 cm Ceph: N/A | Pan: CMOS sensor 15x0.6 cm Ceph: Csl flat panel 24.4x30.7 cm | | Sensor Characteristics | Pan: pixel size 100 μm 3D: voxel size down to 79 μm Ceph: N/A | Pan: pixel size 100 μm 3D: voxel size down to 79 μm Ceph: pixel size 120 micron | Pan: pixel size 100 μm 3D: N/A Ceph: N/A | Pan: pixel size 100 μm 3D: N/A Ceph: pixel size 120 micron | | IEC Classification | Class I, Type B | | | | | Nominal line | 230 V ± 10%, 115 V ± 10%, | | | | The following table describes the functionality of each model. Traditional 510(k)- Stellaris 2D, Stellaris 2D Ceph, Stellari 3D & Stellaris 3D Ceph FONA S.r. FONA S.r.l. – Socio Unico - Sede legale e operativa: Via Galilei, 11 - 20057 Assago (MI) Italia - Capitale Sociale 93.000 Euro - Codice Fiscale, Partita I.V.A.: 12983700159 - Iscrizione Registro Imprese di Milano REA:1606385 - Telefono: +39 02 45712171 - Fax: +39 02 45703385 - E-mail: info@fonaitaly.com - Web: www.fonadental.it {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for FONA, a company with the tagline "Closer to You". The word "FONA" is displayed in large, bold, gray letters. Above the word "FONA" is a curved yellow line. Below the word "FONA" is the tagline "CLOSER TO YOU" in smaller, gray letters. | | Stellaris 3D | Stellaris 3D Ceph | Stellaris 2D | Stellaris 2D Ceph | |----------------------------|------------------------------------------------------------------------------|-------------------|--------------|-------------------| | voltage | | | | | | Nominal line frequency | 50/60 Hz | | | | | Nominal current absorption | MAX 10 A @ 230 V, MAX16 A @ 115 V | | | | | Line fuse | T8 A 250V for 230 V version; T15 A 250V for 115 V version | | | | | Mains Resistance | ≤ 0.8 Ohm at 230 V, ≤ 0.4 Ohm at 115 V | | | | | Rating | 1450W | | | | | Curve form of high voltage | High frequency multi-pulse, ripple ≤ 4% | | | | | X-ray Tube | OPX/105 | | | | | Tube voltage | 60 - 86 kV ± 5%, constant potential | | | | | Tube current | 2.5 - 10 mA ± 10%, direct current (DC) | | | | | Focal spot | 0.5 IEC 60336 | | | | | Total filtration | > 2.5 mm Al /70 kV IEC 60522 | | | | | Maximum duty cycle | 1/8 | | | | | Anatomical selection | 4 Patient size levels: Small, Medium, Large, Extra Large | | | | | kV setting | 14 positions in 2 kV steps: from 60 to 86kV | | | | | mA setting | 7 positions according to R'10 scale: 2.5, 3.2, 4, 5, 6.3, 8, 10 mA | | | | | Aiming lights | 3 laser planes: Median Sagittal Vertical, Canine and Frankfurt Horizontal | | | | | Laser beam Class | I | | | | | Laser wavelength | 650 nm | | | | | Laser Output Power | < 0.15 mW at 100 mm | | | | FONA provides technical and maintenance support for this device to ensure proper operation and to answer any questions regarding the functioning of the device. Contact details are provided to all end users and in the user manual. ## Substantial Equivalence: The FONA Stellaris 3D has a rotating arm which performs motor-driven rototranslatory movements that drive the tube housing assembly and the image detector around the patient head according to different orbits that follow the morphologic profile of the patient. Traditional 510(k)- Stellaris 2D, Stellaris 2D Ceph, Stellari 3D & Stellaris 3D Ceph FONA S.r.l {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for FONA. The word "FONA" is in large, gray, sans-serif font. Above the word is a yellow swoosh. Below the word "FONA" is the text "CLOSER TO YOU" in a smaller, gray, sans-serif font. The tube housing assembly includes an X-ray generator that generates a beam of X-ray as per the inputs selected by the user. Depending on the imaging selection i.e. 2D/panoramic, cephalometric or 3D volume reconstructions, the sensors transform the X-rays into electrical signals. The Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices contain the same type of X-rav tube as the FONA XPan DG. FONA XPan DG Plus, FONA ART Plus and FONA ART Plus C devices. The X-ray generator in the ORTHOPHOS SL device is similar in technology as compared to the FONA Stellaris devices. The construction of the panoramic image of the dental arch is made with a thin X-ray vertical beam from the left to the right of the patient. 3D volume reconstruction is obtained from the acquisition of two-dimensional radiographic images (15x15 cm) via the cone-beam technology, then elaborated with a reconstruction algorithm. Stellaris 2D is equipped with a CMOS sensor that allows the acquisition of panoramic images. The reconstruction is obtained from the acquisition of twodimensional radiographic images (15x 0.6 cm) then elaborated with a reconstruction algorithm. Stellaris 2D Ceph and Stellaris 3D Ceph, in addition, is equipped with a cephalometric arm mountable on Stellaris 2D/ Stellaris 3D respectively, which includes a one shot X-Ray sensor and a cephalostat to hold the patient in position during the examination. Accessories like bite block, chin rest, nasal support, temporal resting bars are provided to permit correct patient positioning. The cephalometric models come with nasion reference and side bars with ear plugs to stabilize the head during exposure. These patient positioning items are likely to enter in contact with the patient during the normal use of the device. The use of standard hygienic protective sleeves (not included in the scope of this submission) to avoid crosscontamination among patients, operators and other persons, is mandatory. The Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices with its associated accessories fulfil the biocompatibility requirements of ISO 10993-1:2018. The panoramic and cephalometric exposures are obtained by standard technology that have been used in dental medicine for a very long time. The principle of operation of the Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices remains the same as the predicates. The difference is the type of sensors used which work on similar principles as the sensors found in the predicate devices. Traditional 510(k)- Stellaris 2D, Stellaris 2D Ceph, Stellari 3D & Stellaris 3D Ceph FONA S.r. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for FONA, a company whose slogan is "Closer to You". The logo features the word "FONA" in large, bold, gray letters. Above the word "FONA" is a curved, yellow line that resembles a smile or an arc. Below the word "FONA" is the slogan "CLOSER TO YOU" in smaller, gray letters. The ORTHOPHOS SL predicate device utilises the SIDEXIS software tool for image acquisition, administration, analysis & diagnosis and the images can be stored in the SIDEXIS database. The Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices can be used with the OrisWin DG Suite software for image acquisition and database (not part of this submission), same as the FONA XPan DG, FONA XPan DG Plus, FONA ART Plus and FONA ART Plus C devices. The use of this software is not mandatory. Any software that allows the viewing and management of radiographic images in DICOM format can also be used. Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices have more volume sizes, positions and collimations than the predicate devices. This results in more possibilities to get an exposure of relevant dento maxillofacial areas. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for FONA. The word "FONA" is written in large, gray, sans-serif letters. Above the word "FONA" is a yellow swoosh. Below the word "FONA" are the words "CLOSER TO YOU" in smaller, gray, sans-serif letters. | | Subject Device | Predicate Device | Reference Device | |--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | ORTHOPHOS SL 2D, ORTHOPHOS SL 2D Ceph, ORTHOPHOS SL 3D and ORTHOPHOS SL 3D Ceph | FONA XPan DG, FONA XPan DG Plus, FONA ART Plus & FONA ART Plus C | | Manufacturer Name | FONA S.r.l | Sirona Dental Systems GmbH | FONA S.r.l | | Device Classification Regulation | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 872.1800 | | Classification Name | Computed Tomography X-ray system | Computed tomography x-ray system | Extraoral Source X-Ray System | | Product Code(s) | OAS | OAS | MUH | | Regulatory Class | 2 | 2 | 2 | | 510(k) | K213579 | K150217 | K161131 | | Indications for Use | Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry. Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry, as well as carpal images for dental clinical investigation. | The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry, including pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and for carpus exposures. | The FONA Pan/Ceph device, comprising models FONA XPan DG, FONA XPan DG Plus, FONA ART Plus, and FONA ART Plus C, is an extraoral source dental X-ray system intended to perform panoramic or cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry, as well as carpal images. | | | Subject Device | Predicate Device | Reference Device | | Device Name | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | ORTHOPHOS SL 2D, ORTHOPHOS SL 2D Ceph, ORTHOPHOS SL 3D and ORTHOPHOS SL 3D Ceph | FONA XPan DG, FONA XPan DG Plus, FONA ART Plus & FONA ART Plus C | | | Stellaris 3D: Extraoral source dental X-ray system intended to perform 3D and panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry. | | | | | Stellaris 3D Ceph: Extraoral source dental X-ray system intended to perform 3D, panoramic and cephalometric exams with production of diagnostic images in the dento- maxillo-facial region and in subregions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations. | | | | Panoramic Programs | P1: Adult Full P2: Child Full P3: Adult Partial Front P4: Adult Partial Left P5: Adult Partial Right P6: Adult Dentition P7: Sinuses P8: Bitewing P9: TMJ Open/Closed Mouth | P1: Panoramic exposure P1A: Panoramic exposure, artifact- reduced P1C: Panoramic exposure, constant 1.25x magnification P2: Panoramic exposure, without ascending rami P2A: Artifact-reduced panoramic exposure without ascending rami | P1 Standard Panoramic Adult P2 Panoramic Child P3 Left Dentition P4 Right Dentition P5 Anterior Dentition P6 TMJ lateral view open/closed mouth P7 Frontal View of Maxillary Sinuses P8 Bitewing (only FONA Art Plus / FONA ART Plus C) | | | Subject Device | Predicate Device | Reference Device | | Device Name | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | ORTHOPHOS SL 2D, ORTHOPHOS SL 2D Ceph, ORTHOPHOS SL 3D and ORTHOPHOS SL 3D Ceph | FONA XPan DG, FONA XPan DG Plus, FONA ART Plus & FONA ART Plus C | | | | P2C: Panoramic exposure without ascending rami at a constant magnification of 1.25x | | | | | P10: Panoramic exposure for children | | | | | P10A: Panoramic exposure for children, without ascending rami, artifact-reduced | | | | | P10C: Panoramic exposure for children, without ascending rami, constant 1.25x magnification | | | | | P12: Thick slice, anterior tooth region | | | | | BW1: Bitewing exposures in the posterior tooth region | | | | | BW2: Bitewing exposures in the anterior tooth region | | | | | TM1.1/TM1.2: Temporomandibular joints from a lateral aspect with the mouth open and closed, two-part exposure | | | | | TM3: Temporomandibular joints lateral, ascending rami | | | | | S1: Paranasal sinuses | | | | | S3: Paranasal sinuses, linear slice orientation | | | Cephalometric Programs | C1: LL (Latero-Lateral) large view C2: LL (Latero-Lateral) small view C3: AP (Anterior-Posterior) / PA (Postero-Anterior) view C4: CEPH Carpus | C1: Posterior-anterior exposure, symmetrical C2: Anterior-posterior exposure, symmetrical C3: Lateral exposure C3F: Full-format exposure, lateral | FONA XPan DG Plus: • P8 Antero-posterior • P9 Letro-lateral • P10 Carpus FONA ART Plus C • P9 Antero-posterior | | | Subject Device | Predicate Device | Reference Device | | Device Name | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | ORTHOPHOS SL 2D, ORTHOPHOS SL 2D Ceph, ORTHOPHOS SL 3D and ORTHOPHOS SL 3D Ceph | FONA XPan DG, FONA XPan DG Plus FONA ART Plus & FONA ART Plus C | | | | C4: Carpus view, symmetrical | P10 Latero-lateral P11 Carpus | | 3D Reconstructions (for 3D model only) | V1: Adult Full View | VOL1 (HS, SD, Low): Volume exposure with a diameter of approx. 8 cm and a height of approx. 8 cm or 5.5 cm collimated. | Not Available | | | V2: Adult Upper Jaw – Surgical/ Implant | VOL2 (HS, SD, Low): Volume exposure with a diameter of about 5 cm and a height of about 5.5 cm for upper or lower mandible. | | | | V3: Adult Lower Jaw - Surgical/ Implant | VOL3 (HS, SD, Low) (optional): Volume exposure with a diameter of about 11 cm and a height of about 10 cm or selection of upper quadrant collimated to 7.5 cm and selection lower quadrant collimated to8.0 cm | | | | V4: Adult Sinuses | | | | | V5: Child Full | | | | | V6: Child Upper Jaw - Surgical/ Implant | | | | | V7: Child Lower Jaw - Surgical/ Implant | | | | | V8: Child Sinuses | | | | | V9: Upper+Lower Jaws - Surgical/Implant Front | | | | | V10: Upper+Lower Jaws - Surgical/Implant Left | | | | | V11: Upper+Lower Jaws - Surg…