ORTHODONTIC ACRYLIC (NOT FINALIZED)

K141439 · Bisco, Inc. · EBI · Sep 12, 2014 · Dental

Device Facts

• Record ID: K141439
• Device Name: ORTHODONTIC ACRYLIC (NOT FINALIZED)
• Applicant: Bisco, Inc.
• Product Code: EBI · Dental
• Decision Date: Sep 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Orthodontic Acrylic intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.).

Device Story

Orthodontic Acrylic is a fast-curing, self-cure 2-part system consisting of a powder and a liquid. When combined, the components polymerize into a hard methacrylate finished product used for fabricating orthodontic appliances like retainers and bite guards. The device incorporates Quaternary Ammonium Methacryloxy Silicate (QAMS). It is intended for use by dental professionals in a clinical setting. The device benefits patients by providing a material for custom orthodontic appliance construction. Clinical decision-making is supported by the material's physical and mechanical properties, which are verified against ISO standards.

Clinical Evidence

Bench testing only. Physical/mechanical properties (flexural strength, flexural modulus, fracture toughness, water sorption, water solubility) tested per ISO 20795-2:2010. Biocompatibility testing performed per ISO 7405:2008 and ISO 10993 (sensitization, oral mucosal irritation, cytotoxicity). In-vitro testing conducted on Candida albicans, Streptococcus mutans, and Actinomyces naselundii. No in-vivo clinical studies performed.

Technological Characteristics

Self-cure 2-part methacrylate resin system (powder/liquid). Contains Quaternary Ammonium Methacryloxy Silicate (QAMS). Tested per ISO 20795-2:2010 (mechanical) and ISO 7405:2008/ISO 10993 (biocompatibility).

Indications for Use

Indicated for the fabrication of methacrylate-based orthodontic appliances, including retainers, bite guards, and bite plates.

Regulatory Classification

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.

Predicate Devices

• Ortho-Jet Acrylic Resin - Sparkle (K941925)
• Ortho-Jet (pre-amendment device)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 12, 2014

Lang Dental Manufacturing Co., Inc. c/o Michelle Schlitz-Taing Regulatory Affairs Product Registration Manager Bisco. Inc. 1100 West Irving Park Road Schaumburg, IL 60193

Re: K141439

Trade/Device Name: Orthodontic Acrylic Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Codes: EBI Dated: June 24, 2014 Received: June 26, 2014

Dear Ms. Schlitz-Taing:

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.

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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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# 510 (k) SUMMARY

| Applicant: | Lang Dental Manufacturing Company Incorporated<br>175 Messner Drive<br>P.O. Box 969<br>Wheeling, Illinois 60090-0969 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michelle Schiltz-Taing<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | 22 May 2014 |
| Trade Name:<br>Common Name: | Orthodontic Acrylic<br>Fast Curing Orthodontic Acrylic Resin Powder and Liquid |
| Product Code:<br>Classification/Name: | EBI<br>Denture relining, repairing, or rebasing resin<br>Class II per 21 CFR 872.3760 |
| Predicate Devices: | |

Orthodontic Acrylic is substantially equivalent to the following Lang Dental Manufacturing Company Incorporated's:

Ortho-Jet Acrylic Resin - Sparkle (K941925) and Ortho-Jet (a pre-amendment device in continuous distribution since 1969)

# Indications for Use:

Orthodontic Acrylic intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.).

### Description of Applicant Device:

Orthodontic Acrylic is a fast curing self-cure 2-part system. The 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 is based upon industry standard chemistry. The Orthodontic Acrylic Liquid contains Quaternary Ammonium Methacryloxy Silicate (QAMS). In-vitro testing on Candida albicans, Streptococcus mutans and Actinomyces naselundii was conducted. In-vivo clinical studies to evaluate the effect of QAMS in the oral

# www.lango

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environment and the prevention of bacteria and fungus-induced stomatitis have not been performed.

Comparisons of the chemical composition of Orthodontic Acrylic to the predicate are provided in the following table:

| Chemical Composition | Ortho-Jet Acrylic Resin -<br>Sparkle<br>K941925 | Orthodontic<br>Acrylic |
|-----------------------------------------------------|-------------------------------------------------|------------------------|
| Auto-Polymerizing | X | X |
| Methacrylate Resin | X | X |
| Plasticized poly-methyl methacrylate | X | X |
| 3:1 (Powder: Liquid) ratio | X | X |
| Quaternary Ammonium Methacryloxy<br>Silicate (QAMS) | --- | X |

### Performance Data:

The physical/mechanical properties of Orthodontic Acrylic were tested in the lab using ISO 20795-2:2010 for flexural strength, flexural modulus, fracture toughness, water sorption, and water solubility. The information provided in this 510(k) for Orthodontic Acrylic compared to the predicate demonstrates that they are similar.

In-vitro testing was conducted on Candida albicans, Streptococcus mutans and Actinomyces naselundii.

# Biocompatibility:

An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to testing requirements to determine the safety of Orthodontic Acrylic.

Orthodontic Acrylic was tested for Guinea Pig Maximization Sensitization Testing and Oral Mucosal Irritation (150 10993-10) and cytotoxicity (150 10993-5); Orthodonic Acrylic met the requirements for these tests.

# Conclusion:

Side by side comparisons demonstrate that the applicant device is substantially equivalent to the predicate legally marketed devices.

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