(666 days)
Infinity / Infinity Cross Flex Dental Systems are intended for use in general dental applications by providing the dental practitioner a user interface to control of the dental chair and attached dental devices. The, system delivers air, water and vacuum to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed by the dentist / dental assistant.
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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Infinity / Infinity Cross Flex Dental Systems" does not contain any information regarding acceptance criteria, device performance metrics, study design (sample sizes, data provenance, expert qualifications, adjudication methods), or details about a multi-reader multi-case (MRMC) study or standalone algorithm performance.
This document is a standard FDA clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device. It specifies the product name, regulation number, regulatory class, and product code. It also outlines the general controls provisions of the Act that the manufacturer must comply with, and provides contact information for regulatory inquiries. The "Indications for Use" section simply states the intended general dental applications of the device, which involves controlling dental chairs and delivering air, water, and vacuum for patient treatment procedures.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This information would typically be found in the more detailed technical documentation submitted as part of the 510(k) application, which is not included here.
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August 9, 2021
Olsen Industria e Comercio S.A. % Lilian Llull Regulatory Affairs Manager TechLink International 16445 Collins Ave # 522 Sunny Isles, Florida 33160
Re: K180935
Trade/Device Name: Infinity / Infinity Cross Flex Dental Systems Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: Class I, reserved Product Code: EIA
Dear Lilian Llull:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 5, 2020. Specifically, FDA is updating this SE Letter for incorrect manufacturer name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Michael Adjodha, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6276, Michael.Adjodha@fda.hhs.gov.
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the text "ADMINISTRATION".
February 5, 2020
Olsen Insdústria de Equipamentos Odontomédicos % Lilian Llull Regulatory Affairs Manager TechLink International 16445 Collins Ave # 522 Sunny Isles, Florida 33160
Re: K180935
Trade/Device Name: Infinity / Infinity Cross Flex Dental Systems Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: Class I, reserved Product Code: EIA Dated: December 26, 2019 Received: January 7, 2020
Dear Lilian Llull:
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.
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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 (21 CFR Part 807); labeling (21 CFR Part 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,
Image /page/2/Picture/5 description: The image shows the name "Michael E. Adjodha -S" in a large, sans-serif font. The text is arranged vertically, with "Michael E." on the top line and "Adjodha -S" on the bottom line. The text is black, and the background is white.
Digitally signed by Michael E. Adjodha -S Date: 2020.02.05 11:25:25 -05'00'
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180935
Device Name Infinity / Infinity Cross Flex Dental Systems
Indications for Use (Describe)
Infinity / Infinity Cross Flex Dental Systems are intended for use in general dental applications by providing the dental practitioner a user interface to control of the dental chair and attached dental devices. The, system delivers air, water and vacuum to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed by the dentist / dental assistant.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart G) |
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.