(82 days)
The indication for use of Ortho-1 is a bracket bonding system in the oral cavity of dental patients.
Ortho-1 is an orthodontic no-mix direct bonding system consisting of Paste, a Primer, and Liquid Etchant. The micromechanical bond to enamel utilizes the acid.etch technique and Bisco's unique composite chemistry. Ortho-1 will bond to brackets (such as metal, plastic, or porcelain) without additional conditioners. Ortho-1 will also bond any type of bracket to properly conditioned dental material restorative materials (such as porcelain, composites, and metal).
The acceptance criteria and study proving the device meets those criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Property | Acceptance Criteria (Predicate) | Reported Device Performance (Ortho-1) |
|---|---|---|
| Chemical Composition | Chemical Cure Present | Chemical Cure Present (X) |
| Solvent-free, unfilled, methacrylate-based primer present | Solvent-free, unfilled, methacrylate-based primer present (X) | |
| Silica filled methacrylate-based paste present | Silica filled methacrylate-based paste present (X) | |
| Phosphoric Acid present (Liquid Etchant) | Phosphoric Acid present (X) | |
| Physical/Mechanical Properties | Low viscosity Primer (Ortho-One K962946) | Low viscosity Primer (X) |
| Tacky Paste (Ortho-One K962946) | Tacky Paste (X) | |
| Medium viscosity paste (Not specified for predicate) | Medium viscosity paste (X) | |
| Low viscosity paste (Not specified for predicate) | Low viscosity paste (X) | |
| High viscosity paste (Ortho-One K962946) | High viscosity paste (X) | |
| Low viscosity, semi-gel (Bisco Etchants K101485) | Low viscosity, semi-gel (X) | |
| Green color (Bisco Etchants K101485) | Green color (X) | |
| Biocompatibility | Safe for intended uses (implied from legally marketed predicate) | Cytotoxicity-agarose diffusion testing conducted; safe for intended uses |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a numerical sample size for the test set. The performance data section states that "The physical/mechanical properties of Ortho-1 and Liquid Etchant were tested in the lab using R&D testing protocols."
The data provenance is retrospective, as the testing was conducted in a lab setting by the manufacturer (BISCO, Inc.) for the purpose of demonstrating substantial equivalence to predicate devices. The country of origin can be inferred as USA, where BISCO, Inc. is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance data appears to be based on internal R&D testing protocols rather than expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document, as the testing described is primarily laboratory-based physical/mechanical property comparison, not clinical evaluation requiring adjudication.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an orthodontic adhesive, and the evaluation focuses on its chemical and physical properties for bonding, not on interpretation by human readers. Therefore, the concept of improvement with AI assistance is not applicable in this context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical orthodontic adhesive, not a software algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation is primarily comparison to established chemical and physical characteristics of legally marketed predicate devices. For biocompatibility, "cytotoxicity-agarose diffusion testing" was conducted, indicating a laboratory-based biological assessment.
8. The Sample Size for the Training Set
This information is not applicable as this is not an artificial intelligence or machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is not an artificial intelligence or machine learning device that requires a training set.
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Image /page/0/Picture/1 description: The image shows the logo for BISCO. The logo is made up of hexagons with the letters B, I, S, C, and O inside. Below the logo is the text "Bringing Science to the Art of Dentistry™".
FEB - 7 2012
510 (k) SUMMARY
Applicant:
Contact Person:
Date Prepared: Trade Name: Common Name: Product Code: Classification/Name: Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193 Michelle Schiltz-Taing Tel: 847-534-6146 Fax: 847-534-6146
Ortho-1 Orthodontic Adhesive DYH Bracket Adhesive Resin Class II per 21 CFR 872.3750
Predicate Devices:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Light Bond (Quick Cure) by Reliance Orthodontic Products Inc., Itasca IL K001048: And Bisco Etchants by Bisco, Inc. Schaumburg IL K101485.
Indications for Use:
The indication for use of Ortho-1 is a bracket bonding system in the oral cavity of dental patients.
Description of Applicant Device:
Ortho-1 is an orthodontic no-mix direct bonding system consisting of Paste, a Primer, and Liquid Etchant. The micromechanical bond to enamel utilizes the acid.etch technique and Bisco's unique composite chemistry. Ortho-1 will bond to brackets (such as metal, plastic, or porcelain) without additional conditioners. Ortho-1 will also bond any type of bracket to properly conditioned dental material restorative materials (such as porcelain, composites, and metal).
Technological Characteristics:
All components of Ortho-1 are based upon industry standard monomer chemistry and are found in the legally marketed predicate device Ortho-One (K962946) and Bisco Etchants K101485. Comparisons of the chemical composition of Ortho-1 to the predicates are provided on the following page:
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.
800-247-3368 or 847-534-6000 Fax: 847-891-5049 ww.bisco.com
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Image /page/1/Picture/0 description: The image shows the logo for BISCO, a dental supply company. The logo consists of the letters "BISCO" arranged in a hexagonal pattern. Below the logo is the tagline "Bringing Science to the Art of Dentistry."
| Chemical Composition | Ortho-OneK962946 | Ortho-1 |
|---|---|---|
| Chemical Cure | X | X |
| Solvent free, unfilled, methacrylate based primer | X | X |
| Silica filled methacrylate based paste | X | X |
| Chemical Composition | Bisco EtchantsK101485 | Liquid Etchant |
| Phosphoric Acid | X | X |
Performance Data:
The physical/mechanical properties of Ortho-1 and Liquid Etchant were tested in the lab using R&D testing protocols. The information provided in this 510(k) of Ortho-1 and Liquid Etchant compared to the predicates demonstrates that they are effective for its indications of use. A comparison of the physical/mechanical properties are included below: --
| Physical / Mechanical PropertyComparison | Ortho-OneK962946 | Ortho-1 |
|---|---|---|
| Low viscosity Primer | X | X |
| Tacky Paste | X | X |
| Medium viscosity paste | X | |
| Low viscosity paste | X | |
| High viscosity paste | X | X |
| Physical / Mechanical PropertyComparison | Bisco EtchantsK101485 | Liquid Etchant |
|---|---|---|
| Low viscosity, semi-gel | X | X |
| Green color | X | X |
Biocompatibility:
An evaluation of biocompatibility was conducted to determine the safety of Ortho-1 and Liquid Etchant. Ortho-1 had cytotoxicity-agarose diffusion testing conducted. The conclusions of the safety evaluations are that Ortho-1 and Liquid Etchant are safe for their intended uses.
Conclusion:
Side by side comparisons clearly demonstrate that the applicantially equivalient to other legally marketed devices. It is concluded that the information supplied in this submission has BISCO, Inc. proven the safety and efficacy of these products.
An ISO 13485 Certified Company
1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A. 800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle or bird-like figure with outstretched wings, rendered in black. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is also in black and is arranged around the upper and left portions of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 7 2012
Ms. Michelle Schiltz-Taing Regulatory Affairs Coordinator BISCO, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K113401
Trade/Device Names: Ortho-1 Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: November 15, 2011 Received: November 17, 2011
Dear Ms. Schiltz-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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Page 2 - Ms. Schiltz-Taing
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number (if known):
Device Name: _ Ortho-1
Indications for Use:
The indication for use of Ortho-1 is a bracket bonding system in the oral cavity of dental patients.
2113 40
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rummie
(Division Sign-Offi) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113401
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.