(77 days)
OptiBond SE is a two-component self-etch universal adhesive system designed to be used for all direct and indirect applications including, but not limited to, the following: Direct Applications - Light-cured composite and compomer restorations - Composite/ceramic/metal repairs - Cavity sealing for amalgam restorations - Sealing of hypersensitive and/or exposed root surfaces - Core build-ups (self-cured, light-cured or dual-cured) Indirect applications - Veneers - Porcelain, composite, and metal-based (including zirconia-based and aluminabased) inlays, onlays, crowns, bridges - Endodontic posts - Cavity sealing as a pretreatment for indirect restorations
OptiBond SE is a two-component self-etch universal adhesive system including a self-etch PRIMER and a universal ADHESIVE. The self-etch primer provides effective etching to uncut enamel and dentin, without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure. The adhesive component is 15% filled with 0.4 micron barium glass to help reinforce bond strength. The material's chemistry allows for compatibility with all self-cure or dual-cure resin cements and core build-up materials. Dentists can therefore utilize OptiBond SE for their direct and indirect procedures without the need for a secondary bonding system.
The provided text describes OptiBond SE, a dental adhesive, and states its substantial equivalence to a predicate device based on biocompatibility and bench testing. However, it does not include information about acceptance criteria or a study that evaluates its performance against those criteria in a manner typically associated with AI/ML device evaluations. The document is a 510(k) summary for a medical device (a resin tooth bonding agent), which means the "study" referred to is about demonstrating substantial equivalence through specific performance characteristics.
Therefore, many of the requested fields regarding AI/ML study specifics (like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and effect size of human reader improvement) are not applicable to this document.
Here's the information that can be extracted from the provided text, structured to address your request as much as possible for a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility | A biocompatibility study was completed, demonstrating the material is safe for its intended use. (Implied to meet safety standards for dental materials). |
| Direct Bonding Strength to Various Materials | Bench testing evaluated direct bonding strength to various dental materials including dentin, enamel, composite, porcelain, gold, and PFM. (Implied to be comparable or superior to the predicate device, OptiBond All-In-One, to establish substantial equivalence). |
| Indirect Bonding Strength to Various Materials | Bench testing evaluated indirect bonding strength to various dental materials including dentin, enamel, composite, porcelain, gold, and PFM. (Implied to be comparable or superior to the predicate device, OptiBond All-In-One, to establish substantial equivalence). |
| Compatibility with Curing Mechanisms | Material's chemistry allows for compatibility with all self-cure or dual-cure resin cements and core build-up materials. (Implied to perform effectively with these, no direct acceptance criteria or comparative performance data against predicate specifically on this point are detailed in the provided text, but it's a stated characteristic). |
| Intended Use Applications | Designed for all direct and indirect applications (listed in detail above). (Implies the device performs adequately for these stated uses, presumably comparable to the predicate). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an AI/ML study. It refers to "bench testing" to evaluate performance characteristics.
- Sample Size: Not specified for the bench tests.
- Data Provenance: The nature of bench testing implies lab-generated data. No country of origin is mentioned for the data, but the submission is from a US company for FDA approval. The testing would be considered prospective in the sense that it was conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. "Ground truth" in this context would refer to the accurate measurement and assessment of bonding strength and biocompatibility in a lab setting, not expert interpretation of diagnostic images or clinical data. No experts are mentioned in this capacity.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication" process described for the results of the bench testing. Lab tests typically rely on standardized protocols and quantitative measurements.
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
Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
For the bench testing and biocompatibility study, the "ground truth" would be established by:
- Quantitative measurements: Direct and indirect bonding strengths are measured values (e.g., in MPa).
- Biocompatibility standards: Adherence to established biological safety standards for medical devices, which typically involve specific in vitro and in vivo tests to assess cytotoxicity, irritation, sensitization, genotoxicity, etc.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
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APR 3 0 2010
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: April 2010
Device Name:
- . Trade Name - OptiBond SE
- Common Name Bonding Agent .
- . Classification Name -- Resin Tooth Bonding Agent, per 21 CFR § 872.3200
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, OptiBond All-In-One .
Device Description:
· OptiBond SE is a two-component self-etch universal adhesive system including a self-etch PRIMER and a universal ADHESIVE. The self-etch primer provides effective etching to uncut enamel and dentin, without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure. The adhesive component is 15% filled with 0.4 micron barium glass to help reinforce bond strength. The material's chemistry allows for compatibility with all self-cure or dual-cure resin cements and core build-up materials. Dentists can therefore utilize OptiBond SE for their direct and indirect procedures without the need for a secondary bonding system.
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Intended Use of the Device:
- OptiBond SE is a two-component self-etch universal adhesive system designed ● to be used for all direct and indirect applications including, but not limited to, the following:
Direct Applications
- Light-cured composite and compomer restorations .
- . Composite/ceramic/metal repairs
- . Cavity sealing for amalgam restorations
- . Sealing of hypersensitive and/or exposed root surfaces
- Core build-ups (self-cured, light-cured or dual-cured) .
Indirect applications
- . Veneers
- Porcelain, composite, and metal-based (including zirconia-based and alumina-● based) inlays, onlays, crowns, bridges
- Endodontic posts
- Cavity sealing as a pretreatment for indirect restorations ●
Substantial Equivalence:
OptiBond SE is substantially equivalent to one other legally marketed device in the United States. OptiBond SE functions in a manner similar to and is intended for the same use as OptiBond All-In-One that is currently marketed by Kerr Corporation. A biocompatibility study was completed, which demonstrates that the material is safe for its intended use.
This 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of OptiBond SE compared to the predicate device, OptiBond All-In-One. The characteristics evaluated include direct and indirect bonding strength to various materials readily found in the dental industry including, but not limited to dentin, enamel, composite, porcelain, gold and PFM.
Based upon the biocompatibility test and bench testing, the clinical performance of Optibond SE is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with a simple, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Kerr Corporation Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
APR 30 2010
Re: K100347
Trade/Device Name: OptiBond SE Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 8, 2010 Received: February 12, 2010
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.
.
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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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Susan Burns
Anthony 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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Indications for Use
510(k) Number (if known):
Device Name: OptiBond SE
Indications For Use:
OptiBond SE is a two-component self-etch universal adhesive system designed to be used for all direct and indirect applications including, but not limited to, the following:
Direct Applications
- Light-cured composite and compomer restorations ●
- Composite/ceramic/metal repairs .
- Cavity sealing for amalgam restorations .
- . Sealing of hypersensitive and/or exposed root surfaces
- Core build-ups (self-cured, light-cured or dual-cured) .
Indirect applications
- Veneers .
- . Porcelain, composite, and metal-based (including zirconia-based and aluminabased) inlays, onlays, crowns, bridges
- Endodontic posts ●
- Cavity sealing as a pretreatment for indirect restorations
Prescription Use X (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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K100347 |
|---|---|
| ---------------- | --------- |
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§ 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.