(79 days)
Not Found
No
The document describes a chemical primer for dental restorations and does not mention any computational or data-driven processes indicative of AI/ML.
No
The device is described as a "universal restoration primer" used for indirect restorations and intraoral repairs of fractured crowns and bridges, which are dental materials and procedures, not directly treating a disease or health condition.
No
The device is a universal restoration primer used for indirect restorations and intraoral repairs. It is not used to diagnose a medical condition.
No
The device description and intended use clearly indicate a physical product (a universal restoration primer) used in dental procedures, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Primer Plus is a "universal restoration primer" used for bonding dental restorations and repairing fractured crowns and bridges. This is a direct application to a patient's teeth/mouth, not a test performed on a sample taken from the body.
- Device Description: The description reinforces its function as a primer for restorations.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Measuring analytes or biomarkers
The device is a dental material used in restorative procedures, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Primer Plus is a universal restoration primer. The principle uses of the Primer Plus are:
- Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics)
- Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, porcelain, zirconia, alumina, ceramics, hybrid ceramics, or composite resin)
Product codes
KLE
Device Description
The Primer Plus is a universal restoration primer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An evaluation of biocompatibility was conducted to determine the safety of the Primer Plus using FDA and internationally recognized guidelines. The conclusion of the safety evaluation and subsequent testing is that the Primer Plus is safe for its intended use.
Side by side comparisons clearly demonstrate that the applicant device is substantially equivalent to other legally marketed devices. It is concluded that the information supplied in this submission has proven the safety and efficacy of this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for BISCO. The logo consists of the letters "BISCO" in a stylized font, with each letter contained within a hexagon. Below the logo is the text "Bringing Science to the Art of Dentistry".
AUG 2 8 2009
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: 847-534-6000 Fax: 847-534-6111 June 9, 2009 Primer Plus Universal Restoration Primer KLE Resin tooth bonding Agent Class II per 21 CFR 872.3200
Description of Applicant Device:
The Primer Plus is a universal restoration primer.
The principle uses of the Primer Plus are:
-
- Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics).
-
- Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, porcelain, zirconia, alumina, ceramics, hybrid ceramics, or composite resin).
Substantial Equivalence
All components of the Primer Plus are found in legally marketed predicate devices. The Primer Plus is based upon industry standard monomer chemistry and has similar technological characteristics as other legally marketed devices. Information is provided in this 510(k) submission that . the Primer Plus is substantially equivalent to the predicate devices Clearfil Ceramic Primer (K061906) and One Step Plus (K011159) in terms of intended use, indications for use, chemical composition and physical properties.
An evaluation of biocompatibility was conducted to determine the safety of the Primer Plus using FDA and internationally recognized guidelines. The conclusion of the safety evaluation and subsequent testing is that the Primer Plus is safe for its intended use.
Side by side comparisons clearly demonstrate that the applicant device is substantially equivalent to other legally marketed devices. It is concluded that the information supplied in this submission has proven the safety and efficacy of this product.
An ISO 13485 Certified Company
BISCO, Inc. 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
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Michelle Schiltz-Taing Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
JG 2 8 2009
Re: K091705
Trade/Device Name: Primer Plus Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 9, 2009 Received: June 10, 2009
Dear Ms. 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.
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.
2
Page 2 - Ms. 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Suarez
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510 (k) Number (if known):
Device Name: Primer Plus
Indications for Use:
Primer Plus is a universal restoration primer.
The principle uses of the Primer Plus are:
-
- Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics)
K091705
- Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics)
-
- Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, 1 porcelain, zirconia, alumina, ceramics, hybrid ceramics, or composite resin)
Prescription Use ✓ (Part 21 CFR 801 Subpart D) AND/OR
- Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, 1 porcelain, zirconia, alumina, ceramics, hybrid ceramics, or composite resin)
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)
Kevin Miller for NSE
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091705