(102 days)
K941925, Ortho-Jet (a pre-amendment device in continuous distribution since 1969)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a material, with no mention of AI or ML.
No
The device is a material (Orthodontic Acrylic) used for fabricating orthodontic appliances, not the therapeutic device itself. These appliances are used to apply force to teeth for orthodontic treatment, hence the material itself is not a therapeutic device.
No
Explanation: The device is an orthodontic acrylic used for fabricating appliances like retainers, not for diagnosing conditions.
No
The device is a physical material (acrylic powder and liquid) used to fabricate orthodontic appliances, not a software program.
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 used in the oral environment. This is a device used on or in the body for a therapeutic or corrective purpose, not for diagnosing a condition by testing samples in vitro (outside the body).
- Device Description: The description details a material that hardens to form a physical appliance. This aligns with a medical device used for treatment or correction, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the material and its resistance to certain microorganisms, which are relevant to its use as an orthodontic appliance, not as a diagnostic tool.
Therefore, this device falls under the category of a medical device used for orthodontic treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Orthodontic Acrylic 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 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.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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.
K941925, Ortho-Jet (a pre-amendment device in continuous distribution since 1969)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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.
1
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 (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" (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 (800) 638-2041 or (301) 796-7100 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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50 (k) Number (if known) 6 E F L F T Y
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LANG®
510 (k) SUMMARY
| Applicant: | Lang Dental Manufacturing Company Incorporated
175 Messner Drive
P.O. Box 969
Wheeling, Illinois 60090-0969 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michelle Schiltz-Taing
Tel: 847-534-6146
Fax: 847-534-6146 |
| Date Prepared: | 22 May 2014 |
| Trade Name:
Common Name: | Orthodontic Acrylic
Fast Curing Orthodontic Acrylic Resin Powder and Liquid |
| Product Code:
Classification/Name: | EBI
Denture relining, repairing, or rebasing resin
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
4
Image /page/4/Picture/0 description: The image shows the logo for LANG. The logo is in a light gray color, except for the "A" which has a blue arrow going through it. There is a line going through the bottom of the letters.
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 -
Sparkle
K941925 | Orthodontic
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
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.