(170 days)
Not Found
No
The summary describes a material used for fabricating orthodontic appliances and focuses on its physical, mechanical, and antimicrobial properties. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as inhibiting adhesion of Candida albicans and reducing Streptococcus mutans and Actinomyces naselunii, and a limited clinical study shows it reduces biofilm formation, which indicates a therapeutic function.
No
Explanation: The device is intended for the fabrication of orthodontic appliances, which are used for treatment (e.g., retainers, bite guards), not for diagnosing a condition or disease. The performance studies focus on physical properties, antimicrobial effects, and biocompatibility of the material itself.
No
The device description clearly states it is a "fast curing self-cure 2 part system consists of a powder and a liquid" which are physical components, not software. The performance studies also focus on physical and biological properties of the material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of orthodontic appliances that are placed in the mouth (retainers, bite guards, bite plates). This is a direct interaction with the patient's body, not an in vitro test performed on samples taken from the body.
- Device Description: The device is a material used to create a physical appliance.
- Performance Studies: While some of the performance studies involve in vitro testing (like the anti-bacterial and anti-fungal tests), these tests are evaluating the properties of the material itself and its effect on microorganisms, not diagnosing a condition in a patient. The clinical study also evaluates the performance of the appliance in reducing biofilm formation in patients.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
Therefore, Orthodontic Acrylic 2 is a medical device used for fabricating orthodontic appliances, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Orthodontic Acrylic 2 is intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.).
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
Orthodontic Acrylic 2 is a fast curing self-cure 2 part system consists of a powder and a liquid. The combination of the powder and liquid is converted into a hard methacrylate finished product.
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
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In-vitro testing of Orthodontic Acrylic 2 shows that QAMS inhibits adhesion of Candida albicans and reduces Streptococcus mutans and Actinomyces naselunii for at least 3 months.
Orthodontic Acrylic 2 containing QAMS has been shown in a limited clinical study involving 32 patients to reduce biofilm formation on the surface of the appliance, as compared to Orthodontic Acrylic that does not contain QAMS. In addition, in-vitro studies conducted after three months showed a substantial reduction in S. mutans, A. naeslundii and C. albicans biofilm formation on the device.
Physical / Mechanical Property Orthodontic Acrylic 2:
Flexural Strength (ISO 20795-2:2010): Orthodontic Acrylic 2 meets the requirements of ISO 20795-2:2010 for flexural strength.
Flexural Modulus (ISO 20795-2:2010): Orthodontic Acrylic 2 meets the requirements of ISO 20795-2:2010 for flexural modulus.
Fracture Toughness (ISO 20795-2:2010): Orthodontic Acrylic 2 meets the requirements of ISO 20795-2:2010 for fracture toughness.
Water sorption (ISO 20795-2:2010): Orthodontic Acrylic 2 meets the requirements of ISO 20795-2:2010 for water sorption.
Water Solubility ( ISO 20795-2:2010): Orthodontic Acrylic 2 meets the requirements of ISO 20795-2-2010 for water solubility.
Anti-Bacterial Testing (in vitro): Orthodontic Acrylic 2 is equivalent to the predicate against S. mutans and A. naeslundii.
Anti-fungal testing (in vitro): Orthodontic Acrylic 2 is equivalent to the predicate against C. albicans.
Biocompatibility: An evaluation of biocompatibility was conducted using ISO 10993-1:2009. Orthodontic Acrylic 2 was tested for Guinea Pig Maximization Testing and Oral Mucosal Irritation (ISO 10992-10) and cytotoxicity (ISO 10993-5); Orthodontic Acrylic 2 met the requirements for these tests.
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
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2017
Lang Dental Manufacturing Co., Inc. Dave Lang President 175 Messner Drive Po Box 969 Wheeling, Illinois 60090
Re: K163482
Trade/Device Name: Orthodontic Acrylic 2 Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: February 27, 2017 Received: March 3, 2017
Dear Dave Lang:
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
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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
Indications for Use
510(k) Number (if known)
Device Name Orthodontic Acrylic 2
Indications for Use (Describe)
Orthodontic Acrylic 2 is intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.)
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)
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3
510(k) SUMMARY
| Applicant: | Lang Dental Manufacturing Company Incorporated
175 Messner Drive
P. O. Box 969
Wheeling, Illinois 60090-0969 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David Lang
Tel: 847-215-6622
Fax: 847-215-6678 |
| Date Prepared: | 30 May, 2017 |
| Trade Name:
Common Name: | Orthodontic Acrylic 2
Fast Curing Orthodontic Acrylic Resin Powder and Liquid |
| Product Code:
Classification/Name: | EBI
Denture relining, repairing, or rebasing resin
Class II per CFR 872.3760 |
Predicate Devices:
Orthodontic Acrylic 2 is substantially equivalent to the following Lang Dental Manufacturing Company Incorporated's:
Orthodontic Acrylic, K141439
Indications for Use:
Orthodontic Acrylic 2 is intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.).
Description of Applicant Device:
Orthodontic Acrylic 2 is a fast curing self-cure 2 part system consists of a powder and a liquid. The combination of the powder and liquid is converted into a hard methacrylate finished product.
Technological Characteristics:
Orthodontic Acrylic 2 is based upon industry standard chemistry. The Orthodontic Acrylic 2 Liquid contains Quaternary Ammonium Methacryloxy Silicate (QAMS). Since QAMS is copolymerizable, the antibacterial/antifungal properties are independent of loss of surface layer since it is incorporated throughout the entire polymer network. In-vitro testing of Orthodontic Acrylic 2 shows that QAMS inhibits adhesion of Candida albicans and reduces Streptococcus mutans and Actinomyces naselunii for at least 3 months.
4
Orthodontic Acrylic 2 containing QAMS has been shown in a limited clinical study involving 32 patients to reduce biofilm formation on the surface of the appliance, as compared to Orthodontic Acrylic that does not contain QAMS. In addition, in-vitro studies conducted after three months showed a substantial reduction in S. mutans, A. naeslundii and C. albicans biofilm formation on the device. QAMS in Orthodontic Acrylic 2 aids in keeping the oral appliance clean and is not a substitute for regular cleaning of the appliance by the patient. A reduction in biofilm on the surface of appliance has not been shown to have enhanced clinical outcomes.
The indications for use of Orthodontic Acrylic 2 are the same as those for Orthodontic Acrylic and are summarized in the table below:
Orthodontic Acrylic
Orthodontic Acrylic is intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.).
Orthodontic Acrylic 2
Orthodontic Acrylic 2 is intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards and bite plates, etc.).
Comparison of the chemical composition of Orthodontic Acrylic 2 to the predicate is provided in the following table:
| Chemical Composition | Orthodontic
Acrylic | Orthodontic
Acrylic 2 |
|----------------------|-----------------------------------|-----------------------------------|
| Formulation | Methacrylate liquid | Methacrylate liquid |
| Formulation | Powder | Powder |
| Presentation | 2-part system | 2-part system |
| Polymerization | Self-Cured | Self-Cured |
| Additional Feature | Anti-bacterial/ Anti-Fungal Agent | Anti-bacterial/ Anti-Fungal Agent |
Performance Date:
The following physical/mechanical properties of Orthodontic Acrylic 2 were tested: Physical / Mechanical Property Orthodontic Acrylic 2
| Flexural Strength (ISO 20795-2:2010) | Orthodontic Acrylic 2 meets the requirements of
ISO 20795-2:2010 for flexural strength |
|---------------------------------------|--------------------------------------------------------------------------------------------|
| Flexural Modulus (ISO 20795-2:2010) | Orthodontic Acrylic 2 meets the requirements of
ISO 20795-2:2010 for flexural modulus |
| Fracture Toughness (ISO 20795-2:2010) | Orthodontic Acrylic 2 meets the requirements of
ISO 20795-2:2010 for fracture toughness |
| Water sorption (ISO 20795-2:2010) | Orthodontic Acrylic 2 meets the requirements of
ISO 20795-2:2010 for water sorption |
| Water Solubility ( ISO 20795-2:2010) | Orthodontic Acrylic 2 meets the requirements of
ISO 20795-2-2010 for water solubility |
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Physical / Mechanical Property
Anti-Bacterial Testing (in vitro)
Anti-fungal testing (in vitro)
Orthodontic Acrylic 2
Orthodontic Acrylic 2 is equivalent to the predicate against S. mutans and A. naeslundii. Orthodontic Acrylic 2 is equivalent to the predicate against C. albicans.
Biocompatibility:
An evaluation of biocompatibility was conducted using ISO 10993-1:2009 to determine the biological testing requirements for Orthodontic Acrylic 2.
Orthodontic Acrylic 2 was tested for Guinea Pig Maximization Testing and Oral Mucosal Irritation (ISO 10992-10) and cytotoxicity (ISO 10993-5); Orthodontic Acrylic 2 met the requirements for these tests.
Conclusion:
Side by side comparisons demonstrate that the applicant device is substantially equivalent in safety and effectiveness to the predicate device.