(79 days)
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)
The Primer Plus is a universal restoration primer.
The provided text is for a 510(k) summary for a dental product called "Primer Plus Universal Restoration Primer" by Bisco, Inc. This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
The document is a regulatory submission for a dental material, not an AI/ML diagnostic or assistive device. Therefore, the concepts of "acceptance criteria," "test set," "ground truth," "MRMC study," "standalone performance," and "training set" as they relate to AI/ML device performance are not applicable to this submission.
The document discusses:
- Description of the Device: "Primer Plus is a universal restoration primer."
- Intended Use: Indirect restorations and intraoral repairs of fractured crowns and bridges.
- Substantial Equivalence: The device is being cleared based on its substantial equivalence to legally marketed predicate devices (Clearfil Ceramic Primer (K061906) and One Step Plus (K011159)) in terms of intended use, indications for use, chemical composition, and physical properties.
- Biocompatibility: An evaluation of biocompatibility was conducted to determine safety.
In a traditional medical device 510(k) submission like this, "acceptance criteria" would refer to the performance benchmarks demonstrated by the predicate device that the new device must meet or exceed to prove substantial equivalence. The "study" mentioned would typically involve material property testing (e.g., bond strength, mechanical properties, biocompatibility) to show that the new device performs comparably to the predicates.
However, none of the specific AI/ML-related questions you asked can be answered from this document.
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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
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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.
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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
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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
§ 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.