(70 days)
Not Found
No
The document describes a dental adhesive and its intended use and performance characteristics, with no mention of AI or ML technology.
No.
The device is an adhesive used for bonding dental materials, not for treating or diagnosing diseases or conditions.
No
Explanation: The device is a dental adhesive used for bonding, not for diagnosing medical conditions. Its function is to join or seal, which is a therapeutic or restorative action, not a diagnostic one.
No
The device description clearly indicates that B1P Adhesive is a physical substance (a dental bonding agent) and 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 clearly describes the device as an adhesive for bonding dental materials to teeth (dentin and enamel) and other dental restorations. This is a direct application within the body (or on a part of the body, the teeth).
- Device Description: The description reinforces its use as a dental bonding agent applied directly to the tooth structure.
- Lack of In Vitro Testing: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. There is no mention of this device being used for any such testing of bodily specimens.
- Anatomical Site: The anatomical site is listed as "Dentin and/ or enamel," which are parts of the tooth, not bodily fluids or tissues being tested in vitro.
The device is a dental material used for restorative procedures, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
B1P Adhesive is an adhesive designed to be used for all direct and indirect applications including, but not limited to, the following:
Direct Applications
- Direct bonding to dentin and/ or enamel .
- Bonding composite to composite, porcelain and/ or metal .
- . Opaquing metal (used in conjunction with an opaque resin stain or cement)
- Bonding with dual cure and self cure composite resins, such as cements and core build up . materials
- Amalgam sealing
- Dentin sealing ●
Indirect applications
- Indirect bonding of all composite, all ceramic, PFM and alloy crowns, bridges, inlays, ● onlays and veneers (used in conjunction with resin luting agents)
- Bonding of fiber and metal posts (in conjunction with resin luting agents) ●
Product codes
KLE
Device Description
B1P Adhesive is a fifth generation dental bonding agent that is intended to be used for direct composite bonding and indirect restoration in combination with a dental restorative material. The formula is used based on a total etch technique and combines the primer and adhesive into one component. The application procedure requires steps of acid etching and rinsing, followed by the application of the B1P Adhesive. It is a light curable adhesive with the option of being dual cured when mixed with the dual cure activator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin and/or enamel
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)
Biocompatibility studies have been completed according to ISO 10993, which demonstrates that B1P Adhesive is safe for its intended use.
This 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of B1P Adhesive compared to the predicate devices. The characteristics evaluated include direct and indirect bonding strengths.
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
AUG - 1 2011
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person
Date Summary Prepared: May 2011
Device Name:
- . Trade Name - B1P Adhesive
- . Common Name – Bonding Agent
- . Classification Name - Resin Tooth Bonding Agent, per 21 CFR § 872.3200
- . Product Code: KLE
Devices for Which Substantial Equivalence is Claimed:
- . Pentron Clinical, Dentin Conditioning and Adhesive (Bond 1), K973388
- . Kerr Corporation, Optibond Solo Plus 2, K991808
- Heraeus Kulzer GmbH, IBond Total Etch, K083652
Device Description:
B1P Adhesive is a fifth generation dental bonding agent that is intended to be used for direct composite bonding and indirect restoration in combination with a dental restorative material. The formula is used based on a total etch technique and combines the primer and adhesive into one component. The application procedure requires steps of acid etching and rinsing, followed by the application of the B1P Adhesive. It is a light curable adhesive with the option of being dual cured when mixed with the dual cure activator.
1
Intended Use of the Device:
B1P Adhesive is an adhesive designed to be used for all direct and indirect applications including, but not limited to, the following:
Direct Applications
- Direct bonding to dentin and/ or enamel .
- Bonding composite to composite, porcelain and/ or metal Opaquing metal (used . in conjunction with an opaque resin stain or cement)
- Bonding with dual cure and self cure composite resins, such as cements and core . build up materials
- Amalgam sealing .
- Dentin sealing .
Indirect applications
- Indirect bonding of all composite, all ceramic, PFM and alloy crowns, bridges, . inlays, onlays and veneers (used in conjunction with resin luting agents)
- Bonding of fiber and metal posts (in conjunction with resin luting agents) .
Summary of Technological Characteristics:
B1P Adhesive is substantially equivalent to three other legally marketed devices in the United States: Dentin Conditioning and Adhesive (Bond 1), Optibond Solo Plus 2 and lBond Total Etch.
B1P Adhesive functions in a manner similar to and is intended for the same use as Dentin Conditioning and Adhesive (Bond 1) that is currently marketed by Pentron Clinical. Both products are acetone based and utilize the same adhesive monomer. B1P Adhesive differs in that it incorporates glutaraldehyde as a desensitizer, can be stored at ambient temperature, has both a bottle and a single dose configuration, and requires the use of only one coat.
B1P Adhesive functions in a manner similar to and is intended for the same use as Optibond Solo Plus 2 that is currently marketed by Kerr Corporation. Both products can be stored at ambient temperature, are both applied in a single coat, utilize filler technology to increase bond strength, and are both offered in a bottle and a single dose configuration. B1P Adhesive differs in that it uses a different adhesive monomer and it contains glutaraldehyde as a desensitizer.
B1P Adhesive functions in a manner similar to and is intended for the same use as IBond Total Etch that is currently marketed by Heraeus Kulzer GmbH. Both products contain glutaraldehyde as a desensitizing agent, require the use of only one coat, bond to both dentin and enamel, employ filler technology to increase bond strength, require the use
2
of an etching agent and can both be stored at ambient temperature. B1P Adhesive differs in that it may be dual cured when mixed with the dual cure activator, and employs different main adhesive components.
Non-Clinical Test Data
Biocompatibility studies have been completed according to ISO 10993, which demonstrates that B1P Adhesive is safe for its intended use.
This 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of B1P Adhesive compared to the predicate devices. The characteristics evaluated include direct and indirect bonding strengths.
Clinical Testing
Clinical testing has not been conducted on this product.
Conclusion:
Based upon biocompatibility tests, similar technological characteristics to the predicate devices and bench testing, the clinical performance of B1P Adhesive is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like bird with three curved lines representing its wings. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pentron Clinical C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
AUG - 1 2011
Re: K111431
Trade/Device Name: BIP Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: May 20, 2011 Received: May 23, 2011
Dear Ms. Garman: ·
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.
4
Page 2 – Ms. Garman
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Wh 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
5
Indications for Use
510(k) Number (if known):
( 11 431
Device Name: B1P Adhesive
Indications For Use:
B1P Adhesive is an adhesive designed to be used for all direct and indirect applications including, but not limited to, the following:
Direct Applications
- Direct bonding to dentin and/ or enamel .
- Bonding composite to composite, porcelain and/ or metal .
- . Opaquing metal (used in conjunction with an opaque resin stain or cement)
- Bonding with dual cure and self cure composite resins, such as cements and core build up . materials
- Amalgam sealing
- Dentin sealing ●
Indirect applications
- Indirect bonding of all composite, all ceramic, PFM and alloy crowns, bridges, inlays, ● onlays and veneers (used in conjunction with resin luting agents)
- Bonding of fiber and metal posts (in conjunction with resin luting agents) ●
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
rrence of CDRH, Office of Device Evaluation (ODE)
Susan Fraser
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111431
Page 1 of 1