(170 days)
Orthodontic Acrylic 2 is intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.)
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.
The provided text describes the regulatory clearance for "Orthodontic Acrylic 2" and details its performance against specific acceptance criteria.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Measure) | Reported Device Performance (Orthodontic Acrylic 2) |
|---|---|
| Flexural Strength (ISO 20795-2:2010) | Meets the requirements of ISO 20795-2:2010 for flexural strength. |
| Flexural Modulus (ISO 20795-2:2010) | Meets the requirements of ISO 20795-2:2010 for flexural modulus. |
| Fracture Toughness (ISO 20795-2:2010) | Meets the requirements of ISO 20795-2:2010 for fracture toughness. |
| Water Sorption (ISO 20795-2:2010) | Meets the requirements of ISO 20795-2:2010 for water sorption. |
| Water Solubility (ISO 20795-2:2010) | Meets the requirements of ISO 20795-2:2010 for water solubility. |
| Anti-Bacterial Testing (in vitro) against S. mutans and A. naeslundii | Equivalent to the predicate against S. mutans and A. naeslundii. |
| Anti-fungal testing (in vitro) against C. albicans | Equivalent to the predicate against C. albicans. |
| Guinea Pig Maximization Testing (ISO 10992-10) | Met the requirements for this test. |
| Oral Mucosal Irritation (ISO 10992-10) | Met the requirements for this test. |
| Cytotoxicity (ISO 10993-5) | Met the requirements for this test. |
| Clinical reduction of biofilm formation | Reduced biofilm formation on the surface of the appliance compared to the predicate (Orthodontic Acrylic without QAMS). |
| In-vitro reduction in S. mutans, A. naeslundii, and C. albicans biofilm formation after 3 months | Substantial reduction shown. |
2. Sample size used for the test set and the data provenance:
- Clinical Study: "a limited clinical study involving 32 patients"
- In-vitro Testing (QAMS inhibition): Not explicitly stated, but performed "In-vitro."
- In-vitro Studies (3-month biofilm reduction): Not explicitly stated, but performed "in-vitro."
- Physical/Mechanical Properties: Not explicitly stated, but performed according to ISO 20795-2:2010.
- Biocompatibility Testing: Not explicitly stated, but tested per ISO 10993-1:2009 for various tests.
The provenance of clinical data is not specified (e.g., country of origin, retrospective or prospective), but the mention of a "limited clinical study" suggests it was likely a prospective study. The in-vitro tests are laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies conducted (physical/mechanical, in-vitro antimicrobial, biocompatibility, and a limited clinical study) likely relied on standard laboratory measurements and clinical observations rather than expert consensus for ground truth determination in the way it's typically applied to AI model evaluations (e.g., radiologists reviewing images).
4. Adjudication method for the test set:
This information is not provided. Given the nature of the tests (laboratory measurements, in-vitro studies, and a limited clinical trial comparing biofilm formation), a formal adjudication method like "2+1" or "3+1" for establishing ground truth from multiple readers/experts is not applicable here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not conducted. This device is a material (Orthodontic Acrylic), not an AI-assisted diagnostic or therapeutic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is not an AI algorithm. The performance evaluation is for a physical medical device (orthodontic acrylic material), not a software or AI product.
7. The type of ground truth used:
- Physical/Mechanical Properties: Manufacturer's specifications and compliance with international standards (ISO 20795-2:2010) for material properties (e.g., flexural strength).
- Anti-bacterial/Anti-fungal Testing: Laboratory assays measuring microbial inhibition and biofilm reduction.
- Biocompatibility: Results from validated in-vitro and in-vivo tests as per ISO 10993-1:2009 (e.g., cytotoxicity, irritation, sensitization).
- Clinical Study: Direct measurement of biofilm formation on orthodontic appliances in patients.
8. The sample size for the training set:
This information is not applicable/provided. This is a physical material being evaluated, not a machine learning model that requires a training set. The development of the material involved chemical formulation and testing, not AI training.
9. How the ground truth for the training set was established:
This information is not applicable/provided as there is no training set for this type of device.
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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.
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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
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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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510(k) SUMMARY
| Applicant: | Lang Dental Manufacturing Company Incorporated175 Messner DriveP. O. Box 969Wheeling, Illinois 60090-0969 |
|---|---|
| Contact Person: | David LangTel: 847-215-6622Fax: 847-215-6678 |
| Date Prepared: | 30 May, 2017 |
| Trade Name:Common Name: | Orthodontic Acrylic 2Fast Curing Orthodontic Acrylic Resin Powder and Liquid |
| Product Code:Classification/Name: | EBIDenture relining, repairing, or rebasing resinClass 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.
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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 | OrthodonticAcrylic | OrthodonticAcrylic 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 ofISO 20795-2:2010 for flexural strength |
|---|---|
| Flexural Modulus (ISO 20795-2:2010) | Orthodontic Acrylic 2 meets the requirements ofISO 20795-2:2010 for flexural modulus |
| Fracture Toughness (ISO 20795-2:2010) | Orthodontic Acrylic 2 meets the requirements ofISO 20795-2:2010 for fracture toughness |
| Water sorption (ISO 20795-2:2010) | Orthodontic Acrylic 2 meets the requirements ofISO 20795-2:2010 for water sorption |
| Water Solubility ( ISO 20795-2:2010) | Orthodontic Acrylic 2 meets the requirements ofISO 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.
§ 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.