(147 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on basic power toothbrush components and a trial program kit.
No
The device is described as a power toothbrush to promote good oral hygiene, not to treat or cure a disease or condition. Its use is focused on education and demonstration for hygiene purposes.
No
The device is described as a power toothbrush intended to promote good oral hygiene, not to diagnose any condition. Its use is focused on cleaning and introducing the product to potential users.
No
The device description explicitly states the program kit contains a power toothbrush consisting of a rechargeable handle, a charger, and replacement brush heads, which are hardware components. While software verification and validation are mentioned, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "power toothbrush to promote good oral hygiene." This is a physical device used for cleaning teeth, not for performing tests on biological samples to diagnose or monitor medical conditions.
- Device Description: The description details a power toothbrush, charger, brush heads, and dental sheaths. These are all components of an oral hygiene device.
- No mention of biological samples: There is no indication that this device is used to analyze blood, urine, tissue, or any other biological sample.
- No mention of diagnostic purpose: The purpose is to introduce and promote the use of a toothbrush, not to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Oral-B® iO Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene.
The Oral-B® iO Test Drive Power Brush Trial Program Kit is indicated for use under the direct supervision of a dental professional, exclusively at conventions (e.g. professional, scientific, trade shows), as part of the Oral-B® iO Test Drive Power Brush Trial Program.
Product codes (comma separated list FDA assigned to the subject device)
JEQ
Device Description
The Oral-B® iO Test Drive Power Brush Trial Program for conventions (e.g. professional, scientific, trade shows), is designed to introduce convention delegates to the newest, most advanced Oral-B electric rechargeable toothbrush as a means to promote good oral hygiene. The program kit contains a power toothbrush consisting of a rechargeable handle, a charger, replacement brush heads, and instructions for the proper use and care of the device. The program kit also contains plastic dental sheaths to prevent soiling and therefore allowing for easier cleaning of the multi-user handle. The sheath is manufactured by TIDI Products, LLC, is provided to Procter & Gamble as a finished, packaged non-sterile device (K132953) for inclusion in the program kit as an accessory. Detailed instructions for cleaning and disinfection of the reusable handle are also included. The program kit is indicated for use as an introductory trial, exclusively within the confines of a convention (e.g. professional, scientific, trade shows), under the direct supervision of a dental professional as part of the Oral-B® iO Test Drive Power Brush Trial Program.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Convention attendee (e.g. dentist, hygienist, dental researcher) under the direct supervision of a dental professional (18 years or older).
Dental professionals (e.g. dentist, hygienist, assistants, students) responsible for the cleaning and disinfection of the handle will be trained and supervised (18 years or older).
Intended User / Care Setting
Under the direct supervision of a dental professional, exclusively at conventions (e.g. professional, scientific, trade shows).
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)
Biocompatibility Testing: Biocompatibility was demonstrated through testing consistent with ISO 10993 and FDA's guidance on how to use ISO 10993-1 within a risk management process. Results from cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-12) studies passed all tests, confirming the device was non-cytotoxic, non-sensitizing, and non-irritating after cleaning and disinfection.
Electrical Safety and Electromagnetic Compatibility: Electrical safety testing in accordance with UL 1431, IEC 60335-1, and IEC 60335-2-52 (as outlined in ISO 20127) showed compliant results, confirming risk of fire, shock, and physical injury addressed. Electromagnetic compatibility testing performed in accordance with Title 47 CFR Parts 15B, 15C, and 18 showed compliant results, ensuring unintentional and intentional radiation are within federally proscribed limits.
Software Verification and Validation Testing: Completed in accordance with FDA guidance documents. Verification activities demonstrated that the device performs as intended.
Cleaning and Disinfection Validation Testing: Performed under simulated normal use and worst-case scenarios. Demonstrated satisfactory cleaning and high-level disinfection, and that repeated exposure to cleaning and disinfection procedures had no effect on physical characteristics or performance. Established a reuse life of 240 uses and subsequent cleaning and disinfection cycles.
Human Factors Usability testing: Several formative and a summative Human Factors Usability studies were performed. Formative studies helped develop and test use instructions, software, and training for proper cleaning and disinfection. The summative study validated that users could read and understand product labeling and follow instructions with software aid to properly clean and disinfect the reusable toothbrush handle after training.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6865 Powered toothbrush.
(a)
Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
May 25, 2021
The Procter & Gamble Company Michael Kaminski Principal Scientist 8700 Mason Montgomery Road Mason, Ohio 45040
Re: K200881
Trade/Device Name: Oral-B iO Test Drive Power Brush Trial Program Kit Regulation Number: 21 CFR 872.6865 Regulation Name: Powered toothbrush Regulatory Class: Class I Product Code: JEQ
Dear Michael Kaminski:
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 August 27, 2020. Specifically, FDA is updating this SE Letter for typographical errors in the company name and regulatory class 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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
August 27,2020
The Proctor & Gamble Company Michael Kaminski Principal Scientist 8700 Mason Montgomery Road Mason, Ohio 45040
Re: K200881
Trade/Device Name: Oral-B iO Test Drive Power Brush Trial Program Kit Regulation Number: 21 CFR 872.6865 Regulation Name: Powered Toothbrush Regulatory Class: Class I, reserved Product Code: JEQ Dated: August 5, 2020 Received: August 6, 2020
Dear Michael Kaminski:
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.
2
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.
Bobak Shirmohammadi -S
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 Ouality Center for Devices and Radiological Health
Enclosure
3
K200881
4. Indications for Use Statement
510(k) Number (if known): To Be Assigned
Device Name: Oral-B® iO Test Drive Power Brush Trial Program Kit
Indications for Use:
The Oral-B® iO Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene.
The Oral-B® iO Test Drive Power Brush Trial Program Kit is indicated for use under the direct supervision of a dental professional, exclusively at conventions (e.g. professional, scientific, trade shows), as part of the Oral-B® iO Test Drive Power Brush Trial Program.
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)
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)
4
The Procter & Gamble Company Mason Business Center Mason, Ohio 45040-9462
| 5. 510(k) Summary | |
|---|---|
| K200881 | |
| SUBMITTER | |
| 510(k) Owner: | The Procter & Gamble Company |
| 1 Procter & Gamble Plaza Cincinnati, Ohio 5202 | |
| Telephone: (513) 206-4331 | |
| Establishment Registration Number: 9915005 | |
| Contact Person: | Michael A. Kaminski Ph.D. |
| Principal Scientist Oral Care | |
| The Procter & Gamble Company | |
| Telephone: (513) 206-4331 Email: kaminski.ma@pg.com | |
| Date Prepared: | August 26, 2020 |
| DEVICE | |
| Trade Name: | Oral-B® iO Test Drive Power Brush Trial Program Kit |
| Common Name: | Power Toothbrush |
| Classification Name: | Toothbrush, Powered |
| Product Code: | JEO |
PREDICATE / REFFERENCE DEVICE
The Oral-B® iO Test Drive Power Brush Trial Program kit") is substantially equivalent to the predicate Oral-B® Test Drive Power Brush Trial Program Kit marketed by Procter & Gamble, Premarket Notification Number: K141018, FDA Product Code JEQ (Class I, 510(k) Exempt).
The Oral-B® iO Test Drive Power Brush Trial Program Kit uses as a reference device the Oral-B® iO Rechargeable Toothbrush; a class I, 510(k) exempt device. The reference device is available as an overthe-counter device marketed under regulatory reference number 21 CFR 872.6865. The Oral-B® iO Rechargeable Toothbrush is cited as a reference device because it is for all intents and purposes, the same device as the subject device. The reference device, a 510k exempt device, is compliant with ISO 20127, Dentistry - Powered toothbrushes - General requirements and test methods which we also relied on to demonstrate the performance of the subject device. Additionally, with the exception of the colorant in the adapter which was used in the predicate, all the materials found in the reference device are used in the subject device.
Neither the predicate device nor the reference device have been the subject of any design-related recalls.
5
DEVICE DESCRIPTION
The Oral-B® iO Test Drive Power Brush Trial Program for conventions (e.g. professional, scientific, trade shows), is designed to introduce convention delegates to the newest, most advanced Oral-B electric rechargeable toothbrush as a means to promote good oral hygiene. The program kit contains a power toothbrush consisting of a rechargeable handle, a charger, replacement brush heads, and instructions for the proper use and care of the device. The program kit also contains plastic dental sheaths to prevent soiling and therefore allowing for easier cleaning of the multi-user handle. The sheath is manufactured by TIDI Products, LLC, is provided to Procter & Gamble as a finished, packaged non-sterile device (K132953) for inclusion in the program kit as an accessory. Detailed instructions for cleaning and disinfection of the reusable handle are also included. The program kit is indicated for use as an introductory trial, exclusively within the confines of a convention (e.g. professional, scientific, trade shows), under the direct supervision of a dental professional as part of the Oral-B® iO Test Drive Power Brush Trial Program.
INDICATIONS FOR USE
The Oral-B® iO Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene.
The Oral-B® iO Test Drive Power Brush Trial Program Kit is indicated for use under the direct supervision of a dental professional, exclusively at conventions (e.g. professional, scientific, trade shows), as part of the Oral-B® iO Test Drive Power Brush Trial Program.
The indication for use for the subject device differs from that of the predicate in that we have narrowed the use environment to conventions only. The results in user group, those who will brush their teeth, being a sub population of the predicates target population. The more controlled use environment also allows for the assurance of a regimented and standardized training program to insure proper cleaning and disinfection of the device after use. These differences in indication for use do not affect the safety and effectiveness of the device when used as labeled.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The Oral-B® iO Test Drive Power Brush Trial Program Kit is substantially equivalent to the predicate device. Oral-B® Test Drive Power Brush Trial Program Kit (K141018). The Oral-B® iO Test Drive Power Brush Program Kit that is the subject of this 510(k) differs slightly from the predicate with regards to design, dimensions and materials yet none of these modifications affect the safety or effectiveness of the device. The most notable difference between the Oral-B® iO Test Drive Power Brush Trial Program Kit and the predicate device are a new drive mechanism and elimination of the elastomeric seal that previously presented a physical barrier to saliva and other fluids from potentially contaminating the handle drive shaft. These changes necessitated a change to the reprocessing, including the use of an FDA-cleared high-level disinfectant and is the reason for this pre-market notification. In addition, the target population for the subject device is much more specific in that the Oral-B® iO Test Drive Power Brush Trial Program will be executed at conventions only under the direct supervision of a dental professional and the device cleaned and disinfected by trained professionals. The subject device, the reference and predicate are all manufactured by Procter & Gamble Manufacturing GmbH (Marktheidenfeld, Germany) and distributed in the U.S.A. by Procter & Gamble, Co. (Cincinnati, Ohio).
6
The OTC Oral-B® iO Rechargeable Power Toothbrush (reference device) for all intents and purposes, is the same device as the subject device. Marketed as class I, 510k exempt device, the reference device is available for purchase OTC for consumers and satisfies all the requirements of a class I 510k exempt device including compliance with ISO 20127, Dentistry - Powered toothbrushes - General requirements and test methods.
While there are differences in indication for use, use environment, color of the adapter, software and labelling all have been addressed in the 510k with data that supports a finding of substantial equivalence to the predicate.
7
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) Number | To be assigned | K141018 | Class I, 510(k) exempt |
| Product Code | JEQ | JEQ | JEQ |
| Common Name | Toothbrush, Powered | Toothbrush, Powered | Toothbrush, Powered |
| Trade Name | Oral-B® iO Test Drive Power Brush Trial | ||
| Program Kit | Oral-B® Test Drive Power Brush Trial Program | ||
| Kit | Oral-B® iO Rechargeable Power Toothbrush | ||
| FDA Class | Class I, 510(k) exempt, Rx | Class I, 510(k) exempt, Rx | Class I, 510(k) exempt, OTC |
| Regulation | 21CFR§872.6865 | 21CFR§872.6865 | 21CFR§872.6865 |
| Manufacturer | Procter & Gamble Manufacturing GmbH | Procter & Gamble Manufacturing GmbH | Procter & Gamble Manufacturing GmbH |
| Sold Sterile | No | No | No |
| Description | The Oral-B® iO Test Drive Program allows | ||
| users to experience the benefit of brushing with | |||
| an electric rechargeable toothbrush specifically | |||
| within a convention setting | The Oral-B® Test Drive Power Brush Trial | ||
| Program Kit is a rechargeable power toothbrush | |||
| designed to promote good oral hygiene, including | |||
| the reduction of dental plaque for the treatment and | |||
| prevention of gingivitis. | The Oral-B® iO Power Toothbrush is a rechargeable | ||
| power toothbrush designed to promote good oral | |||
| hygiene, including the reduction of dental plaque for | |||
| the treatment and prevention of gingivitis. | |||
| Indication for Use | The Oral-B® iO Test Drive Power Brush Trial | ||
| Program Kit is intended for use as a power | |||
| toothbrush to promote good oral hygiene. | |||
| The Oral-B® iO Test Drive Power Brush Trial | |||
| Program Kit is indicated for use under the | |||
| direct supervision of a dental professional, | |||
| exclusively at conventions (e.g. professional, | |||
| scientific, trade shows), as part of the Oral-B® | |||
| iO Test Drive Power Brush Trial Program. | The Oral-B® Test Drive Power Brush Trial | ||
| Program Kit is intended for use as a power | |||
| toothbrush to promote good oral hygiene, | |||
| including the reduction of dental plaque, for the | |||
| treatment and prevention of gingivitis. | |||
| The Oral-B® Test Drive Power Brush Trial | |||
| Program Kit is indicated for use under the | |||
| supervision of a dental professional as part of the | |||
| Oral-B® Test Drive Power Brush Trial Program. | The Oral-B® iO Power Toothbrush is intended for use | ||
| as a power toothbrush to promote good oral hygiene by | |||
| removing adherent plaque and food debris from the | |||
| teeth to reduce tooth decay and treat and prevent | |||
| gingivitis. | |||
| Use Environment | Convention (e.g. professional, scientific, trade | ||
| show) under the direct supervision of a dental | |||
| professional. | Dental Office under the supervision of a dental | ||
| professional. | Home | ||
| Subject Device | Predicate Device | Reference Device | |
| Target Population | Convention attendee (e.g. dentist, hygienist, | ||
| dental researcher) under the direct supervision | |||
| of a dental professional (18 years or older). | |||
| Dental professionals (e.g. dentist, hygienist, | |||
| assistants, students) responsible for the | |||
| cleaning and disinfection of the handle will be | |||
| trained and supervised (18 years or older). | Consumer use under dental professional | ||
| supervision (General population 3 years and | |||
| above). | |||
| Dental professionals (e.g. dentist, hygienist, | |||
| assistants) responsible for the cleaning and | |||
| disinfection of the handle did not receive any | |||
| training or supervision (18 years or older). | Over-the-Counter - General population (3 years and | ||
| above) | |||
| Components | Oral-B® iO Test Drive Power Brush Trial | ||
| Program Kit (2 boxes): | |||
| • Oral-B® iO Test Drive Power Toothbrush | |||
| Kit (1 box) | |||
| o Handle (1) | |||
| o Charger (1) | |||
| o User Manual (1) | |||
| • Oral-B® iO Test Drive Refill Kit (1 box) | |||
| o Oral-B® iO brush heads (25) | |||
| o Plastic Sheaths (30) | |||
| o Cleaning and Disinfection Quick | |||
| Reference Guide (1) | |||
| Cleaning and Disinfection Manual (1) | Oral-B® Test Drive Power Brush Trial Program | ||
| Kit (2 boxes): | |||
| • Oral-B® Test Drive Power Toothbrush Kit (1 | |||
| box) | |||
| o Handle (1) | |||
| o Charger (1) | |||
| o User Manual (1) | |||
| • Oral-B® Test Drive Refill Kit (1 box) | |||
| o Oral-B® brush heads (50) | |||
| o Plastic Sheaths (55) | |||
| Cleaning and Disinfection Manual (1) | Oral-B® iO Power Brush (1 box): | ||
| o Handle (1) | |||
| o Charger (1) | |||
| o Oral-B® brush heads (vaiable) | |||
| o User Manual (1) | |||
| Model | Program Kit – Product code 80338870 | ||
| Handle - OPO24 | |||
| Brush Head - ORO20 | |||
| Charger - OPO23 | Program Kit - D34.503.5e | ||
| Handle - D34e | |||
| Brush Head – EB50e | |||
| Charger - 3757 | OTC Kit - Product code 80338571 | ||
| Handle - OPO20 | |||
| Brush Head – ORO15 | |||
| Charger - OPO23 | |||
| Accessory | Disposable plastic sheath to prevent soiling and | ||
| facilitate cleaning (K132953) | Disposable plastic sheath to prevent soiling and | ||
| facilitate cleaning (K132953) | No Applicable | ||
| Labeling | o User Manual | ||
| o Cleaning and Disinfection Manual with | |||
| Quick Start Guide | |||
| o Training Script | |||
| o Checklist for Validation and Revalidation | o User Manual | ||
| o Cleaning and Disinfection Manual | o User Manual | ||
| Subject Device | Predicate Device | Reference Device | |
| Cleaner | Opti-Cide3 Solution | ||
| (EPA Reg. No. 70144-1) | |||
| Micro-Scientific, LLC |
Ingredients: 0.154% n Alkyl (60% C14 30% C15
5% C12 5% C18) dimethyl benzyl ammonium
chloride,
0.154% n Alkyl (68% C12 32% C14) dimethyl
benzyl ammonium chloride,
21% Isopropanol
Contact Conditions: 2 min at 20°C
Or
General Purpose Non-Ammoniated
Ultrasonic Cleaner (e.g. Crosstex)
Crosstex international
Ingredients: