Infinity / Infinity Cross Flex Dental Systems

K180935 · Olsen Industria E Comercio S.A. · EIA · Feb 5, 2020 · Dental

Device Facts

• Record ID: K180935
• Device Name: Infinity / Infinity Cross Flex Dental Systems
• Applicant: Olsen Industria E Comercio S.A.
• Product Code: EIA · Dental
• Decision Date: Feb 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

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.

Device Story

Infinity / Infinity Cross Flex Dental Systems function as a centralized control interface for dental operatory equipment. The system manages the delivery of air, water, and vacuum utilities to support standard dental procedures. It serves as a user interface for the dental practitioner to operate the dental chair and integrated dental instruments. Used in clinical dental settings, the system is operated by dentists or dental assistants to facilitate patient treatment. By providing an intuitive control center, the device streamlines the management of operatory functions, supporting the practitioner in performing routine dental care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental operative unit providing air, water, and vacuum delivery; includes user interface for chair and instrument control. Class I, reserved device (21 CFR 872.6640).

Indications for Use

Indicated for use in general dental applications to provide a control interface for dental chairs and attached dental devices, including delivery of air, water, and vacuum for standard patient treatment procedures performed by dentists or dental assistants.

Regulatory Classification

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.

Submission Summary (Full Text)

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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, [e-mail].

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 [phone] 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) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10px;"> </span> <span style="font-size: 10px;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </div> | <div> <span> <span style="font-size: 10px;"> </span> <span style="font-size: 10px;">Over-The-Counter Use (21 CFR 801 Subpart G)</span> </span> </div> |

> Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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