Who is the manufacturer of T-8000 THEROZONE UNIT?

Therozone USA, Inc. filed the 510(k) submission for T-8000 THEROZONE UNIT (K141504).

What is the FDA product code for T-8000 THEROZONE UNIT?

EIA. It is classified under 21 CFR 872.6640 as a Class 1 device in the Dental panel.

What is the regulatory pathway for T-8000 THEROZONE UNIT?

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

What are the predicate devices for T-8000 THEROZONE UNIT?

UltraKleen (K991946); Odyssey Dental Water Unit (K964796).

Who can help prepare an FDA 510(k) submission like T-8000 THEROZONE UNIT?

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.

T-8000 THEROZONE UNIT

K141504 · Therozone USA, Inc. · EIA · Feb 24, 2015 · Dental

Device Facts

Record ID	K141504
Device Name	T-8000 THEROZONE UNIT
Applicant	Therozone USA, Inc.
Product Code	EIA · Dental
Decision Date	Feb 24, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.6640
Device Class	Class 1
Attributes	Therapeutic

Intended Use

The T-8000 TherOzone Unit is intended for the reduction of microorganisms in dental unit water lines.

Device Story

T-8000 TherOzone Unit cleans dental unit water lines; utilizes ozone generator to create ozone from ambient air; ozonated gas applied to water lines; mechanism involves oxidation leading to cell lysis; operated by dental professionals in clinical settings; daily flush cycle; device consists of ozone generator and dispensing bottles; output is ozonated water for microbial reduction; benefits patient by reducing microbial contamination in dental water systems.

Clinical Evidence

Bench testing only. Performance testing included microbial challenge, software validation, environmental evaluation, functional verification, material compatibility analysis, usability evaluation, and pressure verification. No clinical data provided.

Technological Characteristics

Materials: Polyethylene, Fluoropolymers. Principle: Ozone generation from ambient air via electrical power (100-240VAC). Mechanism: Oxidation/cell lysis. Dimensions: 8"x 9.5" x 18.25". Weight: 12 lbs. Connectivity: Standalone. Sterilization: Non-sterile, reusable.

Indications for Use

Indicated for the reduction of microorganisms in dental unit water lines for use by dental professionals.

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.

Predicate Devices

UltraKleen (K991946)
Odyssey Dental Water Unit (K964796)

Related Devices

K051657 — A-DEC SELF-CONTAINED WATER SYSTEM · A-Dec, Inc. · Aug 30, 2005
K971727 — DCI WATER PURIFIER · Dental Components, Inc. · Sep 12, 1997
K033925 — BIOFREE · Dental Components, Inc. · Apr 7, 2004
K964271 — IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID · Airel-West · Dec 19, 1997
K983847 — MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT · Germiphene Corp. · Dec 1, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 24, 2015 TherOzone USA. Inc. Ms. Rebecca K Pine Official Correspondent 2701 Ocean Park Blvd, Suite 108 Santa Monica, CA 90405 Re: K141504 Trade/Device Name: T-8000 TherOzone Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit (accessory) Regulatory Class: II Product Code: EIA Dated: January 27, 2015 Received: January 28, 2015 #### Dear Ms. Pine: 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. 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. {1}------------------------------------------------ Page 2 - Ms. Pine 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 (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K141504 Device Name T-8000 TherOzone Unit Indications for Use (Describe) The T-8000 TherOzone Unit is intended for the reduction of microorganisms in dental unit water lines. 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 C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ #### 6. 510(k) Summary This 510(k) [K141504] summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | APPLICANT: | TherOzone USA, Inc. | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | DATE PREPARED: | February 24, 2015 | | CONTACT PERSON: | Rebecca K Pine Official Correspondent TherOzone USA, Inc. 2701 Ocean Park Blvd, Suite 108 Santa Monica, CA 90405 Phone: 760.809.5178 FAX: 760.290.3216 Email: beky@cox.net | | TRADE NAME: | T-8000 TherOzone Unit | | COMMON NAME: | Accessory, Dental Unit | | CLASSIFICATION NAME: | Dental Operative Unit (accessory) | | DEVICE CLASSIFICATION: | Class II, per 21 CFR 872.6640 | | PRODUCT CODE | EIA | | PREDICATE DEVICES: | UltraKleen(K991946) Odyssey Dental Water Unit (K964796) | ### Substantially Equivalent To: The T-8000 TherOzone Unit is substantially equivalent in intended use, principal of operation and technological characteristics to the existing UltraKleen and the Odyssey Dental Water Unit devices. ### Description of the Device Subject to Premarket Notification: The T-8000 TherOzone Unit is a device intended to clean dental unit water lines. The device consists of an ozone generator and dispensing bottles. ### Indication for Use: The T-8000 TherOzone Unit is intended for the reduction of microorganisms in dental unit water lines. {4}------------------------------------------------ ### Technical Characteristics: The T-8000 TherOzone Unit has similar physical and technical characteristics to the predicate devices, as illustrated in the table below. | | T-8000 TherOzone Unit | Odyssey I Dental Water Unit Germiphene Corp. (K964796) | UltraKleen, Sterilex (K991946) | Substantial Equivalence | |--------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | For the reduction of microorganisms in dental unit water lines. | Indicated to be used as an in-line water disinfecting system to reduce microorganisms in the dental water lines | The product has been specially formulated and clinically proven to clean deposits and control bacterial contamination in Dental Unit Water Lines. | Although minor grammatical difference exist, the intended use of the subject device is substantially equivalent to the predicate devices | | Function | Dental unit water line cleaner | Dental unit water line cleaner | Dental unit water line cleaner | Same. The subject device is substantially equivalent to the predicate devices. | | Principle of Operation | Creates ozone from air. Ozonated gas (in water) applied to dental unit water lines | Creates ozone from air. Ozonated gas (in water) applied to dental unit water lines | Anti-microbial chemical agent | Same. The subject device is substantially equivalent to the predicate device. | | Mechanism of Action | Oxidation, leading to cell lysis | Oxidation, leading to cell lysis | Oxidation Hydrolysis Microbubbling | Same. The subject device is substantially equivalent to the predicate device. | | Patient contact | None | In-line use | None | Same. The subject device is substantially equivalent to the predicate device. | | Intended User | Dental professional | Dental professional | Dental professional | Same. The subject device is substantially equivalent to the predicate devices. | | Delivery to Site | Direct application to dental water lines | Direct application to dental water lines | Direct application to dental water lines | Same. The subject device is substantially equivalent to the predicate devices. | | Microorganis m reduction cycle | Daily flush through water lines | Continuous flush | Flush with overnight soak | Similar. The subject device cycle varies slightly, but all device cycles | | | T-8000 TherOzone Unit | Odyssey I Dental Water Unit Germiphene Corp. (K964796) | UltraKleen, Sterilex (K991946) | Substantial Equivalence | | Materials (wetted) | Polyethylene Fluoropolymers | Polycarbonate, 304V stainless steel, Kynar, polyethylene | Sodium carbonate Sodium percarbonate Benzenemethanaminium, N, N- dimethyl-N- tetradecyl-. Chloride Tetrasodium EDTA | effective microorganism reduction. The minor differences do not pose a functional difference, therefore the subject device is substantially equivalent to the predicate devices. Similar, subject device and the predicate device are both fabricated from common medical device materials, therefore the subject device and predicate device are substantially equivalent | | Air Supply | Ambient, compressed to 5- 25psi | 60 PSIG, min | N/A | Same. The subject device and predicate device both use a pressurized air source. The differences in operating parameters are minor and do not affect the fundamental technology therefore the subject device and the predicate device are substantially equivalent. | | Electrical | 100-240VAC,50- 60Hz,1.5 65 watts | 100-130 VAC, 50- 60 Hz, 20 watts, grounded | N/A | Same. The subject device and predicate device both use electrical power. The differences in electrical specifications are | | | T-8000 TherOzone Unit | Odyssey I Dental Water Unit Germiphene Corp. (K964796) | UltraKleen, Sterilex (K991946) | Substantial Equivalence | | Water capacity | ~ 600mL | 1 liter (1,000 mL) | N/A | minor and do not affect the fundamental technology therefore the subject device and the predicate device are substantially equivalent. Same. The minor differences in volume do not affect the fundamental technology therefore the subject device and the predicate device are substantially equivalent. | | Water requirements | Distilled only | Distilled only | Distilled only | Same. The subject device is substantially equivalent to the predicate device. | | Equipment Weight (dry) | 12 lbs | 7 lbs | N/A | Same. The minor differences in equipment weight do not affect the fundamental technology therefore the subject device and the predicate device are substantially equivalent. | | Dimensions | 8"x 9.5" X 18 1/4" | 6" x 6" x 12 ½ " | N/A | Same. The minor differences in equipment dimension do not affect the fundamental technology therefore the subject device and the predicate device are substantially equivalent. | | How provided | Non-sterile, reusable | Non-sterile, reusable | Non-sterile, single use | Same. The subject device is | | T-8000 TherOzone Unit | Odyssey I Dental Water Unit Germiphene Corp. (K964796) | UltraKleen, Sterilex (K991946) | Substantial Equivalence | | | | | | substantially equivalent to the predicate device. | | TherOzone USA, Inc. T-8000 TherOzone Unit Page 12 of 56 Premarket Notification {5}------------------------------------------------ TherOzone USA, Inc. T-8000 TherOzone Unit Page 13 of 56 Premarket Notification {6}------------------------------------------------ TherOzone USA, Inc. T-8000 TherOzone Unit Page 14 of 56 Premarket Notification {7}------------------------------------------------ ## Performance Data: All necessary verification and validation testing has been performed for the T-8000 TherOzone Unit to assure substantial equivalence to the predicate devices and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Performance Testing included: - Microbial challenge - Software Validation ● - Environmental Evaluation ● - Functional Verification - Material Compatibility Analysis - Usability Evaluation - Pressure Verification ● - Environmental Condition Verification The performance testing conducted demonstrates that the T-8000 TherOzone Unit is substantially equivalent to the predicate devices. ### Basis for Determination of Substantial Equivalence: Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed, the subject T-8000 TherOzone Unit is substantially equivalent and is as safe and as effective as the legally marketed predicate devices, UltraKleen(K991946) and Odyssey Dental Water Unit (K964796).

T-8000 THEROZONE UNIT

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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T-8000 THEROZONE UNIT

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

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