Acid Etchant

K172953 · American Orthodontics · KLE · Feb 6, 2018 · Dental

Device Facts

• Record ID: K172953
• Device Name: Acid Etchant
• Applicant: American Orthodontics
• Product Code: KLE · Dental
• Decision Date: Feb 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

Device Story

Acid Etchant is a 37% phosphoric acid solution used in dental/orthodontic procedures to etch enamel and dentin. It promotes adhesion of primer/bonding agents to tooth structure and restorative materials. The device is available in two forms: a gel (contained in syringes) and a liquid (contained in dropper bottles). The gel includes silica as a thickener to control flow behavior and viscosity, and a green dye for visual contrast during application. The liquid form is a thickened fluid. The device is used by dental professionals in a clinical setting. By etching the tooth surface, the etchant increases surface area and reactivity, facilitating a stronger bond for subsequent restorative or orthodontic materials, thereby improving the clinical success of the dental treatment.

Clinical Evidence

No clinical performance testing was conducted. Bench testing included performance testing per ISO 29022:2013, viscosity testing, pH and acid content testing, and compatibility testing. Results demonstrated that the subject device performs comparably to the predicate, with average bond strengths of 27.20 N/mm² (gel) and 26.91 N/mm² (liquid) versus 26.71 N/mm² for the predicate.

Technological Characteristics

Composition: 37% phosphoric acid (CAS# 7664-38-2), water, colloidal silica (thickener), and green dye. Forms: Thixotropic gel (syringe) and thickened fluid (dropper bottle). pH: 1.6. Performance standards: ISO 29022:2013 (bond strength).

Indications for Use

Indicated for etching enamel and dentin to facilitate adhesion of dental adhesives to tooth structure and restorative materials in patients undergoing orthodontic or restorative dental procedures.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

• E Dental Products e-1 Etchants (K152110)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.

American Orthodontics Trang Adams Regulatory Affairs Specialist 3524 Washington Avenue Sheboygan, Wisconsin 53081 February 6, 2018

### Re: K172953

Trade/Device Name: Acid Etchant Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: November 13, 2017 Received: November 16, 2017

#### Dear Trang Adams:

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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mary S. Runner -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) unknown K172953

Device Name

Acid Etchant

Indications for Use (Describe)

Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized, blue font, followed by the words "AMERICAN ORTHODONTICS" in a smaller, sans-serif font, also in blue. The "AO" is larger and bolder than the rest of the text, making it the focal point of the logo. The overall design is clean and professional, conveying a sense of trust and expertise.

American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081

www.americanortho.com

1 800 558 7687 [phone] office [phone] fax Page 5-1

K172953

# 510(k) Summary

#### Preparation Date: October 25, 2017

#### Company Information:

American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 Phone: [phone] Fax: [phone]

#### Contact Information:

Trang Adams / Regulatory Affairs Specialist

#### Device Information:

Trade Name: Acid Etchant Common Name: Acid Etchant Classification Name: Agent, Tooth Bonding, Resin Product Code: KLE Regulation Number (21CFR): 872.3200

#### Predicate Device Information:

Product/Trade Name: E Dental Products e-1 Etchants Manufacturer: E Dental Products 510(k) #: K152110 Classification Name: Agent, Tooth Bonding, Resin Product Code: KLE Regulation Number (21CFR): 872.3200

#### Description of the Device:

Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative material. The Acid Etchant will be available in gel and liquid form. The gel form will be contained in syringes and the liquid form will be contained in dropper bottles. Applicator tips will be provided with the gel form.

The Acid Etchant contains water, 37% phosphoric acid (CAS# 7664-38-2), silica and green dye. The silica is used as a thickener. The amount of silica will determine the flow behavior and viscosity of the Acid Etchant. The green dye is to provide contrast to the tooth's color. The combination of the flow behavior, delivery system and green dye provides and facilitates accurate and controlled application of the Acid Etchant during orthodontic treatment.

#### Indications for Use:

Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

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Image /page/4/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized, blue font, followed by the words "AMERICAN ORTHODONTICS" in a smaller, sans-serif font. The word "AMERICAN" is on the top line, and the word "ORTHODONTICS" is on the bottom line. The logo is simple and modern, and the blue color gives it a professional look.

American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081

www.americanortho.com

1 800 558 7687 [phone] office [phone] fax Page 5-2

#### Substantial Equivalence Discussion:

The Indications for Use statement for American Orthodontics' Acid Etchant is not identical to the predicate in that the subject device includes glass ionomer cements and wording is slightly different; however, the differences do not alter the intended use of the device relative to the predicate. Both devices have the same intended use, to be used as etching agents.

Both devices have the same technological characteristics through delivery system, flow behavior, consistency, % Phosphoric Acid (CAS #: 7664-38-2), pH and incorporation of similar materials.

The table below outlines the comparison of the predicate device, E Dental Products e-1 Etchants and American Orthodontics' Acid Etchant to show substantial equivalency.

| Device Name / Manufacturer | | |
|-------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Element | PREDICATE<br>Device: E Dental Products e-1 Etchants<br>Manufacturer: E Dental Products | Device: Acid Etchant<br>Manufacturer: American Orthodontics |
| 510(k) Number | K152110 | unknown |
| Classification Code/<br>Regulation Number | KLE<br>872.3200 | KLE<br>872.3200 |
| Intended Use | Etch enamel, dentin, and glass ionomer cements. | Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials. |
| Delivery System | Syringe | Syringe/Dropper Bottle |
| Material Composition | water<br>phosphoric acid<br>silica<br>dye | water<br>phosphoric acid<br>colloidal silica<br>dye |
| % Phosphoric Acid | 37.0% | 37.0% |
| pH | 1.6 | 1.6 |
| Flow Behavior | Viscous | Viscous/Low Viscous |
| Consistency | Thixotropic Gel | Thixotropic Gel/Thickened Fluid |

The biocompatibility of the predicate device (E Dental Products e-1 Etchants: K152110) and American Orthodontics' Acid Etchant is essentially equivalent due to the fact that the chemical composition and properties are the same. Additionally, the original manufacturer's post-market experience has not shown any significant or adverse events. The predicate device (E Dental Products e-1 Etchants: K152110) did not have any reported issues or recalls according to FDA requirements.

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Image /page/5/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized font, followed by the words "AMERICAN ORTHODONTICS" in a smaller, sans-serif font. The logo is in blue color. The logo is simple and modern.

American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081

www.americanortho.com

1 800 558 7687 [phone] office [phone] fax Page 5-3

### Performance Data:

Clinical Performance Testing No clinical performance testing has been conducted.

Non-Clinical Performance Testing

The following non-clinical performance tests were conducted:

- 1. Performance Test in Accordance with ISO 29022:2013
- 2. Viscosity Testing
- 3. pH and Acid Content Testing
- 4. Compatibility Testing

The combination of in-house testing and side-by-side comparison performed by the original manufacturer has demonstrated the efficacy or suitability to the intended purpose of Acid Etchant. Results of bench testing indicate that Acid Etchant performs as well as the predicate E Dental Products e-1 Etchants. Any slight differences do not affect the original function or intended purpose of the device.

| Device Name: | Average Bond<br>Strength<br>[N/mm²] | Viscosity<br>(Pas): | Calculated<br>pH: | % Phosphoric<br>Acid: |
|--------------------------------------------|-------------------------------------|---------------------|-------------------|-----------------------|
| Acid Etchant (Gel) | 27.20 | 10.8 | 1.6 | 37.5 |
| Acid Etchant (Liquid) | 26.91 | 0.54 | 1.6 | 37.6 |
| E Dental Products e-1 Etchants (Predicate) | 26.71 | 7-4.7 | 1.6 | 37* |

Test Method Summary:

*Stated value from manufacturer

Compatibility Testing: It was determined that there were no incompatibilities or negative interactions found between the acid etchant and packaging/containers.

#### Conclusion:

Acid Etchant has the following similarities to the legally marketed predicate E Dental Products e-1 Etchants (K152110):

- Same intended use, and
- Same technological characteristics through delivery system, flow behavior, consistency, % Phosphoric Acid (CAS #: 7664-38-2), pH and incorporation of similar materials.