(25 days)
No
The description focuses on the hardware components and basic control functions (exposure time, anatomical zones, patient size, receptor type). There is no mention of AI, ML, or advanced image processing that would suggest the use of such technologies.
No.
The device is used for diagnosis, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "diagnosis of diseases related to the anatomical structures of the teeth".
No
The device description explicitly details hardware components including an X-ray generator, CPU, and mechanical suspension system.
Based on the provided information, the FONA XDC is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- FONA XDC Function: The FONA XDC is an intraoral dental X-ray device. Its function is to generate X-rays that pass through the patient's teeth and surrounding structures to create an image. This image is then used by a healthcare professional for diagnosis.
- Mechanism of Action: The device works by emitting radiation and capturing an image, not by analyzing biological samples.
Therefore, the FONA XDC falls under the category of imaging devices used for diagnostic purposes, but it is not an IVD.
N/A
Intended Use / Indications for Use
FONA XDC is an intraoral dental X-ray device intended for dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth in both adult and pediatric patients.
Product codes
EHD
Device Description
The device consists of an X-ray generator, a CPU that manages the exposure time and a mechanical suspension system, for wall mounting or mobile stand.
The image detectors (a necessary component for a fully-functional diagnostic system) are not part of the current submission.
The device, unlike the previous IntraOs 70 with AC power supply of the tube, is powered at constant potential, i.e. direct current, guaranteeing excellent quality of the final image. From an application point of view, FONA XDC radiographic system is similar to the IntraOs 70; it is possible to select nine anatomical zones (two more than in IntraOs 70), two patient body sizes and three types of receptors that can be set at different sensitivities.
The basic radiographic system allows to operate at 20 cm (8") source-skin distance (SSD) with circular radiation beam. The FONA XDC primary collimator, as for the IntraOs 70, consists of a brass cylinder and the limitation of the beam on a circular surface of 6 cm in diameter from the focus for a working distance of 20 cm. It is possible to bring the working distance to 30 cm from the focus by adding a cone extension. It is also possible to reduce the exposed circular area both by working at 20 cm and at 30 cm. with the interposition of rectanqular 3x4 cm or 2x3 cm BLD adaptor, for image receptors of size 2 (adult) or size 0 (child) respectively
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Teeth
Upper incisor
Upper cuspid / premolar
Upper molar
Occlusal upper / lower arch
Occlusal premolar crowns
Occlusal molar crowns
Lower incisor
Lower cuspid / premolar
Lower molar
Indicated Patient Age Range
Adult and pediatric patients.
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)
The device is an evolution of the predicate device based on experience of the predicate device from the field and in compliance with the state of the art in the dental imaging area.
FDA consensus standards have been employed for electrical safety, electromagnetic compatibility, performance and usability. Each produced device is checked against the FDA performance standards for lonizing radiation emitting products. The performance of the predicate device and the subject device have been validated using the same testing models.
Based on the device nature (an x-ray generator similar to the predicate), clinical testing is not required to demonstrate substantial equivalence. Successful bench testing results should be enough proof that the FONA XDC works as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
August 23, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
FONA S.r.l % Krupa Srivastava Regulatory Consultant Via G.Galilei 11 Assago, MILAN 20057 ITALY
Re: K222274
Trade/Device Name: FONA XDC Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: July 29, 2022 Received: July 29, 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 medical devices and radiation-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, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222274
Device Name FONA XDC
Indications for Use (Describe)
FONA XDC is an intraoral dental X-ray device intended for dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth in both adult and pediatric patients.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for FONA, a company that is "Closer to You". The logo consists of the word "FONA" in large, gray, sans-serif letters. Above the word "FONA" is a curved, yellow line. Below the word "FONA" is the phrase "CLOSER TO YOU" in smaller, gray, sans-serif letters.
510(k) SUMMARY
K222274
| Date Prepared: | August 10, 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 | FONA XDC |
| Common Name | Unit, X-Ray, Extraoral With Timer |
| Classification Name | Extraoral source x-ray system |
| Classification Regulation | 21 CFR 872.1800 |
| Product code | EHD |
| Classification | 2 |
Predicate Device:
The predicate device for the FONA XDC along with its 510(k) number is provided below:
| Trade Name | IntraOs 70 |
|---|---|
| 510(k) Number | K031118 |
| Classification Name | Extraoral source x-ray system |
| Classification Regulation | 21 CFR 872.1800 |
| Product code | EHD |
Special 510(k)- FONA XDC FONA S.r.I
FONA S.r.l. - Sede legale Via Victor Hugo 4, 20123 Milano (M) (Ml) Italia - Galileo Gallie, 11 - 20057 Assago
(MI) Italia - Capitale Sociale 10.000 Euro i.v. - Codi 12380490966 - REA: MI - 2657690 - Telefono: +39 02 45712171 - Fax: +39 02 45703385 - E-mail: info@fonaitaly.com - Web: www.fonadental.it
4
Image /page/4/Picture/0 description: The image shows the logo for FONA, a company that is "Closer to You". The logo consists of the word "FONA" 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.
| Classification | 2 |
|---|---|
| ---------------- | --- |
Reference Device:
The reference device for the FONA XDC along with its 510(k) number is provided below:
| Trade Name | Heliodent Plus |
|---|---|
| 510(k) Number | K083344 |
| Classification Name | Extraoral source x-ray system |
| Classification Regulation | 21 CFR 872.1800 |
| Product code | EHD |
| Classification | 2 |
Indications for use
FONA XDC is an intraoral dental X-ray device intended for dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth in both adult and pediatric patients.
Device Description:
The device consists of an X-ray generator, a CPU that manages the exposure time and a mechanical suspension system, for wall mounting or mobile stand.
The image detectors (a necessary component for a fully-functional diagnostic system) are not part of the current submission.
The device, unlike the previous IntraOs 70 with AC power supply of the tube, is powered at constant potential, i.e. direct current, guaranteeing excellent quality of the final image. From an application point of view, FONA XDC radiographic system is similar to the IntraOs 70; it is possible to select nine anatomical zones (two more than in IntraOs 70), two patient body sizes and three types of receptors that can be set at different sensitivities.
The basic radiographic system allows to operate at 20 cm (8") source-skin distance (SSD) with circular radiation beam. The FONA XDC primary collimator, as for the IntraOs 70, consists of a brass cylinder and the limitation Special 510(k)- FONA XDC FONA S.r.
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 is a yellow swoosh. Below the word "FONA" is the phrase "CLOSER TO YOU" in smaller, gray, sans-serif letters.
of the beam on a circular surface of 6 cm in diameter from the focus for a working distance of 20 cm. It is possible to bring the working distance to 30 cm from the focus by adding a cone extension. It is also possible to reduce the exposed circular area both by working at 20 cm and at 30 cm. with the interposition of rectanqular 3x4 cm or 2x3 cm BLD adaptor, for image receptors of size 2 (adult) or size 0 (child) respectively
Substantial Equivalence:
We believe that the FONA XDC, is substantially equivalent to the legally marketed device (the predicate device) in terms of safety and effectiveness.
The primary predicate is the FONA XDC as it is a further development to the IntraOs 70 and performs similar operations and functions.
Both the current FONA XDC and the cleared IntraOs 70 are extra oral source X-ray systems intended for dental radiographic examination and diagnosis of diseases of the teeth.
Both the IntraOs 70 and the FONA XDC are Intraoral dental X-ray devices to be used together with a proper receptor. The medical device is intended to be used in hospitals or in medical dental centers by radiology doctors, dentists and qualified staff who have received proper training. They both can be configured in the wall mounted as well as the mobile versions. The mechanical mobile stand base, the scissor arms and support arms are identical.
Although worded differently, there are no differences between the subject device and the predicate device with respect to indications and intended use.
S.r.l. - Sede legale Via Victor Hugo 4, 20123 Milano (M) Italia - Sede operativa: Via Galileo Galilei, 11 - 20057 Assago Capitale Sociale 10.000 Euro i.v. - Codice Fiscale, Partita I.V.A. e Iscrizione Registro Imprese di Milano: 80490966 - REA: MI - 2657690 - Telefono: +39 02 45712171 - Fax: +39 02 45703385 - E-mail: info@fonaitaly.com - Web www.fonadental.it
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Image /page/6/Picture/0 description: The image shows the logo for FONA, a company that is "Closer to You". The logo consists of the word "FONA" in large, gray, sans-serif letters, with the tagline "CLOSER TO YOU" in smaller, gray letters underneath. Above the word "FONA" is a curved, yellow line that resembles a smile or an arc.
Comparison of the subject modified device to the cleared predicate device
| Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Device Name | FONA XDC | IntraOs 70 | Heliodent Plus |
| Manufacturer Name | FONA S.r.l | FONA S.r.I (Formerly known as Blue | |
| X Imaging S.r.l) | Sirona Dental Systems GmbH | ||
| Product Illustration | Image: FONA XDC | Image: IntraOs 70 | Image: Heliodent Plus |
| Device Classification Regulation | 21 CFR 872.1800 | 21 CFR 872.1800 | 21 CFR 872.1800 |
| Regulation/Classification Name | Extraoral source x-ray system | Extraoral source x-ray system | Extraoral source x-ray system |
| Common Name | Unit, X-Ray, Extraoral with Timer | Unit, X-Ray, Extraoral with Timer | Unit, X-Ray, Extraoral with Timer |
| Product Code(s) | EHD | EHD | EHD |
| 510(k) | K222274 | K031118 | K083344 |
| Device | Predicate Device | Reference Device | |
| Device Name | FONA XDC | IntraOs 70 | Heliodent Plus |
| Intended Use / Indications for Use | FONA XDC is an intraoral dental X- | ||
| ray device intended for dental | |||
| radiographic examination and | |||
| diagnosis of diseases related to the | |||
| anatomical structures of the teeth in | |||
| both adult and pediatric patients. | The IntraOs 70 (with Autoset Timer) is | ||
| intended for the dental radiographic | |||
| examination and diagnosis of | |||
| diseases related to the anatomical | |||
| structures of the teeth. Such a device | |||
| makes use of an extra oral source x- | |||
| ray system commonly referred to as | |||
| intraoral x-ray equipment. | The Heliodent Plus is an X-ray device | ||
| for established dental surgeries and | |||
| clinics intended to be used for | |||
| intraoral radiography for examination | |||
| and diagnosis of diseases of the | |||
| teeth, jaw, and oral structures. | |||
| Power Supply | DC | AC | DC |
| Line Voltage | 110-127 V ± 10% | ||
| 220-240 V ± 10% | 110-120 V (from 99 V to 132 V) | ||
| 220-24 OV (from 198 V to 264 V) | 120 V ± 10% | ||
| 200-240 V ± 10% | |||
| Line Fuse | T 8AH at 110-127 V | ||
| T 5AH at 220-240 V | 6.3 A at 115 V | ||
| 4 A at 230 V | 16 A slow blow | ||
| Line Frequency | 50-60 Hz | 50/60 Hz ± 1 Hz | 50/60 Hz |
| Line Resistance | ≤ 0.5 Ohm at 110-127 V | ||
| ≤ 1.0 Ohm at 220-240 V | ≤ 0.4 Ohm at 115 V | ||
| ≤ 0.8 Ohm at 230 V | 0.3 Ohm at 120 V | ||
| 0.8 Ohm at 200-240 V | |||
| Maximum Line Current | 8 A at 110-127 V | ||
| 5 A at 220-240 V | 6 A at 120 V | ||
| 4 A at 230 V | 10 A at 120 V | ||
| 6-5 A at 200-240 V | |||
| Focal Spot | 0.4 as per IEC 60336 | 0.8 as per IEC 60336 | 0.4 as per IEC 60336 |
| Inherent Filtration | ≥ 2.3 mm Al at 70 kV | > 2.5 mm Al at 70 kVp | > 1.5 mm Al at 70 |
| Tube Voltage | 60 or 70 kV ± 5% selectable | 70 kVp ± 8% at nominal line voltage | |
| 66 kVp ± 8% at nominal line voltage - | |||
| 10% | |||
| 74 kVp ± 8% at nominal line voltage+ | |||
| 10% | 60 kV / 70 kV switchable | ||
| (max. tolerance ± 5 kV) | |||
| Tube Current | 7 mA ± 10% | 7.0 mA ± 15% at nominal line voltage | |
| 5.3 mA ± 15% at nominal line voltage – | |||
| 10% | |||
| 8.3 mA ± 15% at nominal line voltage |
- 10% | 7 mA (max. tolerance ± 1.4 mA) |
| | Device | Predicate Device | Reference Device |
| Device Name | FONA XDC | IntraOs 70 | Heliodent Plus |
| Anatomical Areas | Upper incisor
• | Maxillary incisor
• | Maxillary front tooth
• |
| | Upper cuspid / premolar
• | Maxillary canine or premolar
• | Maxillary canine / premolar
• |
| | Upper molar,
• | Maxillary molar
• | Maxillary molar
• |
| | Occlusal upper / lower arch
• | Mandibular incisor
• | Bite-wing exposure
• |
| | Occlusal premolar crowns
• | Mandibular canine or premolar
• | Mandibular front tooth
• |
| | Occlusal molar crowns
• | Mandibular molar
• | Mandibular canine / premolar
• |
| | Lower incisor
• | Bite-wing premolar
• | Mandibular molar
• |
| | Lower cuspid / premolar
• | | |
| | Lower molar
• | | |
| Image receptors | Film, Phosphor plate, digital sensor | Film and digital sensor | Film and digital sensor |
| Patient population | Adult and Child | Adult and Child | Adult and Child |
| Exposure time | 0.01-3.2 s ± 5% | 0.06-3.2 s ± 5% | 0.01 – 3.2 s |
| | R20 scale | R10 scale | (max. tolerance ± 10% +1 ms) |
| | | | |
| Principle of Operation | The device consists of an X-ray | The device consists of an X-ray | The device consists of
an X-ray |
| | generator, a CPU that manages the | generator, a CPU that manages the | generator, a CPU that manages the |
| | exposure time and a mechanical | exposure time and a mechanical | exposure time and a mechanical |
| | suspension system, for wall mounting | suspension system, for wall mounting | suspension system, for wall mounting |
| | or mobile stand. | or mobile stand. | or mobile stand. |
| | The device is powered at constant | IntraOs 70 is a traditional AC tube- | The device is powered at constant |
| | potential, i.e. direct current. | head, 70 kVp, 7 mA. | potential, i.e. direct current. |
| Xray exposure time control | Microprocessor controlled | Microprocessor controlled | Microprocessor controlled |
| Sterilization | Not Sterile, disinfect and use | Not Sterile, disinfect and use | Not Sterile, disinfect and use |
| Operating Conditions | Temperature 10°C to 40°C | Temperature 10°C to 40°C | Ambient temperature +10°C - +35°C |
| | Humidity 30 to 75% | Humidity 30 to 75% | With room temperatures > 35°C (> |
| | Pressure 700 to 1060 hPa | Pressure 700 to 1060 hPa | 95°F) |
| | | | Dentsply Sirona recommends the use |
| | | | of |
| | | | an air conditioning system. |
| | | | Relative humidity: 30% - 85% (no |
| | | | condensation) |
| | Device | Predicate Device | Reference Device |
| Device Name | FONA XDC | IntraOs 70 | Heliodent Plus |
| Performance Standards | IEC 60601-1 (Electrical Safety) | IEC 60601-1 (Electrical Safety) | IEC 60601-1 (Electrical Safety) |
| | IEC 60601-1-2 (EMC) | IEC 60601-1-2 (EMC) | IEC 60601-1-2 (EMC) |
| | IEC 60601-1-3 (Radiation Protection) | IEC 60601-1-3 (Radiation Protection) | IEC 60601-1-3 (Radiation Protection) |
| | IEC 60601-2-65 (Performance) | IEC 60601-2-65 (Performance) | IEC 60336 (Focal Spots) |
| | IEC 60336 (Focal Spots) | IEC 60336 (Focal Spots) | IEC 60601-2-65 (performance) |
| | IEC 62304 (Software) | IEC 62304 (Software) | |
| | IEC 60601-1-6 & IEC 62366-1
(Usability) | IEC 60601-1-6 & IEC 62366-1
(Usability) | |
| | IEC 61223-3-4 (performance) | IEC 61223-3-4 (performance) | |
| | ISO 10993-1 (Biocompatibility) | ISO 10993-1 (Biocompatibility) | |
| | 21CFR1020.30 & 21CFR 1020.31 | 21CFR1020.30 & 21CFR 1020.31 | |
Page 4 of 8
Ill FON Sci. - Sede legale Via Victor Hugo 4, 20123 Millio Galler Callier Callier Catile 10,00 Euro in - Codice Sociale 10,00 Euro i. - Codice Fiscale, Partile III. - Corizio Registro Imprese di Miano: 12380490966 - REA: NI - 2657690 - Telefon: +39 02 45703385 - E-mail: info@fonaitay.com - Web: www.fonadental.i.
7
Image /page/7/Picture/0 description: The image shows the logo for FONA, a company whose slogan is "Closer to You". The logo consists of the word "FONA" 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.
Page 5 of 8
ll FONA S.r.I. - Sece legale Via Victor Hugo 4, 2012 Milen Callie, 11 - 2005 Assap (M) Jalia - Capitele Sociale 10,000 Euro i. - Codize Fisale, Partid V.A. e sozizine Registro Imprese di Miano: 1230049096 - REA: M - 2657690 - Telefon: +39 02 45703385 - E-mail: info@fonaitaly.com - Web: www.fonadental.i.
8
Image /page/8/Picture/0 description: The image shows the logo for FONA. The logo consists of the word "FONA" in large, gray, sans-serif letters. Above the word "FONA" is a curved, yellow line. Below the word "FONA" are the words "CLOSER TO YOU" in smaller, gray, sans-serif letters.
Page 6 of 8
■ FONA S.r.l. - Sede legale Via Vidia - Sede cperatia: Va Galles Galle, 11 - 2007 Assago (M) Jalia - Copitele Sociale 10.00 Euro i.r. - Codie Fisale, Partia V.A. e sozizn Registro Imprese di Miano: 1230049096 - REA: M - 2657690 - Telefon: +39 02 45703385 - E-mail: info@fonaitaly.com - Web: www.fonadental.i.
9
Image /page/9/Picture/0 description: The image shows the logo for FONA, a company whose slogan is "Closer to You". The logo consists of the word "FONA" in large, bold, gray letters. Above the word "FONA" is a yellow arc. Below the word "FONA" are the words "CLOSER TO YOU" in smaller, gray letters.
Page 7 of 8
ll FONA S.r.I. - Sece legale Via Victor Hugo 4, 2012 Milen Callie, 11 - 2005 Assap (M) Jalia - Capitele Sociale 10,000 Euro i. - Codize Fisale, Partid V.A. e sozizine Registro Imprese di Miano: 1230049096 - REA: M - 2657690 - Telefon: +39 02 45703385 - E-mail: info@fonaitaly.com - Web: www.fonadental.i.
10
Image /page/10/Picture/0 description: The image shows the logo for FONA. The word "FONA" is written in large, gray, sans-serif letters. Above the word is a yellow swoosh. Below the word "FONA" is the phrase "CLOSER TO YOU" in smaller, gray, sans-serif letters.
Summary of Non Clinical Testing:
The device is an evolution of the predicate device based on experience of the predicate device from the field and in compliance with the state of the art in the dental imaging area.
FDA consensus standards have been employed for electrical safety, electromagnetic compatibility, performance and usability. Each produced device is checked against the FDA performance standards for lonizing radiation emitting products. The performance of the predicate device and the subject device have been validated using the same testing models.
Based on the device nature (an x-ray generator similar to the predicate), clinical testing is not required to demonstrate substantial equivalence. Successful bench testing results should be enough proof that the FONA XDC works as intended.
Conclusion:
The proposed device has the same intended use and principles of operation as the predicate device.
There are no significant changes to the materials, dimensions or to the assembly process of the device. No new biocompatibility testing is deemed to be required as compared to the predicate device.
In conclusion, the FONA XDC is as safety and effective as the predicate device.
Special 510(k)- FONA XDC