(133 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of the etchant, with no mention of AI or ML.
No.
This device is a dental etchant used to prepare tooth surfaces for bonding, which is not considered a therapeutic function.
No
The device is an etchant used to promote adhesion of dental materials, not to diagnose a condition or disease.
No
The device description explicitly states it is a phosphoric acid etchant available in gel and liquid forms, contained in syringes and dropper bottles, and includes applicator tips. This indicates a physical chemical substance and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials." This is a direct treatment or preparation of the tooth structure for a dental procedure.
- Device Description: The description details the chemical composition and physical form of the etchant, which is applied directly to the tooth.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to test samples like blood, urine, tissue, etc., to gain information about a patient's health status. This device is a material used in a dental procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel and dentin (tooth structure)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Clinical Performance Testing No clinical performance testing has been conducted.
Non-Clinical Performance Testing
The following non-clinical performance tests were conducted:
-
- Performance Test in Accordance with ISO 29022:2013
-
- Viscosity Testing
-
- pH and Acid Content Testing
-
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average Bond Strength [N/mm²]:
Acid Etchant (Gel): 27.20
Acid Etchant (Liquid): 26.91
E Dental Products e-1 Etchants (Predicate): 26.71
Viscosity (Pas):
Acid Etchant (Gel): 10.8
Acid Etchant (Liquid): 0.54
E Dental Products e-1 Etchants (Predicate): 7-4.7
Calculated pH:
Acid Etchant (Gel): 1.6
Acid Etchant (Liquid): 1.6
E Dental Products e-1 Etchants (Predicate): 1.6
% Phosphoric Acid:
Acid Etchant (Gel): 37.5
Acid Etchant (Liquid): 37.6
E Dental Products e-1 Etchants (Predicate): 37* (*Stated value from manufacturer)
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
§ 872.3200 Resin tooth bonding agent.
(a)
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.(b)
Classification. Class II.
0
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);
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
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
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax Page 5-1
510(k) Summary
Preparation Date: October 25, 2017
Company Information:
American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 Phone: 920-457-5051 Fax: 920-457-5773
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.
4
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
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 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 | |
| Device: E Dental Products e-1 Etchants | ||
| Manufacturer: E Dental Products | Device: Acid Etchant | |
| Manufacturer: American Orthodontics | ||
| 510(k) Number | K152110 | unknown |
| Classification Code/ | ||
| Regulation Number | KLE | |
| 872.3200 | KLE | |
| 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 | |
| phosphoric acid | ||
| silica | ||
| dye | water | |
| phosphoric acid | ||
| colloidal silica | ||
| 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.
5
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
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 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:
-
- Performance Test in Accordance with ISO 29022:2013
-
- Viscosity Testing
-
- pH and Acid Content Testing
-
- 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
Strength
[N/mm²] | Viscosity
(Pas): | Calculated
pH: | % Phosphoric
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.