(82 days)
No
The device description focuses on the chemical and mechanical properties of a bonding system, with no mention of AI or ML.
No
The device is described as a bracket bonding system for orthodontic use, which is a dental adhesive system, not a therapeutic device designed to treat or prevent disease.
No
The device is described as a bracket bonding system used for orthodontic purposes, primarily for bonding brackets to teeth. Its function is to facilitate mechanical bonding, not to diagnose medical conditions or diseases.
No
The device description clearly states that Ortho-1 is a "direct bonding system consisting of Paste, a Primer, and Liquid Etchant," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "a bracket bonding system in the oral cavity of dental patients." This describes a device used directly on a patient's body for a therapeutic or structural purpose (bonding brackets).
- Device Description: The description details a system for bonding orthodontic brackets to teeth and restorative materials. This is a physical process performed within the oral cavity.
- Lack of In Vitro Testing: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The description and performance studies focus on the physical and mechanical properties of the bonding system itself, not on analyzing biological samples.
- Anatomical Site: The anatomical site is the "oral cavity," indicating direct application to the patient.
Therefore, Ortho-1 is a medical device used in vivo (within the living body) for a dental procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indication for use of Ortho-1 is a bracket bonding system in the oral cavity of dental patients.
Product codes (comma separated list FDA assigned to the subject device)
DYH
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity of dental patients.
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 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 Property Comparison | Ortho-One K962946 | 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 Property Comparison | Bisco Etchants K101485 | Liquid Etchant |
|---|---|---|
| Low viscosity, semi-gel | X | X |
| Green color | X | X |
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.
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
§ 872.3750 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.
0
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
1
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-One
K962946 | Ortho-1 |
|---------------------------------------------------|---------------------------|----------------|
| Chemical Cure | X | X |
| Solvent free, unfilled, methacrylate based primer | X | X |
| Silica filled methacrylate based paste | X | X |
| Chemical Composition | Bisco Etchants
K101485 | 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 Property
Comparison | Ortho-One
K962946 | 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 Property
Comparison | Bisco Etchants
K101485 | 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
2
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.
3
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
4
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