(89 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of a dental adhesive system, with no mention of AI or ML capabilities.
No
The device is an adhesive system used for dental restorations, not for treating or curing a disease or condition. It facilitates bonding, which is a restorative function, not therapeutic.
No
This device is an adhesive system used for bonding dental restorations and core build-ups. It does not perform any diagnostic functions.
No
The device description clearly states it is a two-component universal adhesive system (PRIMER and ADHESIVE), which are physical substances, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a dental adhesive system used for bonding various restorative materials to tooth structure. This is a direct application within the body (or on a part of the body, the tooth), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a two-component adhesive system for bonding, not a reagent or instrument used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), diagnosing diseases, or providing information about a patient's health status based on laboratory testing.
- Performance Studies: The performance studies focus on shear bond strength, which is a measure of the adhesive's physical properties and effectiveness in bonding, not its ability to detect or measure substances in biological samples.
Therefore, this device falls under the category of a dental restorative material/adhesive, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Direct Bonding 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 Bonding Applications
- Veneers.
- Self-cure, dual-cure, light-cure resin cements and core buildup materials.
- Porcelain, ceramic (including zirconia-based, lithium disilicate-based and alumina-based), composite, and metal-based (including precious and non-precious metal inlays, onlays, crowns, bridges.
- Endodontic posts.
- Cavity sealing as a pretreatment for indirect restorations.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
OptiBond eXTRa Universal is a two-component universal adhesive system including a PRIMER and an ADHESIVE. The OptiBond eXTRa Universal PRIMER provides effective etching to enamel and dentin without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure (self-etch technique). OptiBond eXTRa Universal is compatible with total etch and selective etch techniques. The OptiBond eXTRa Universal ADHESIVE is 15% filled with 0.4 micron barium glass to help reinforce bond strength.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel and dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed Dental Professionals
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)
Bench testing was conducted on a variety of self-cure or dual-cure resin cements and core-build up materials. The following performance tests were completed during the product lifecycle: Non-clinical performance data includes testing for shear bond strength to various substrates. The data analyzed from the various tests substantiate that OptiBond eXTRa Universal performs similar to the predicate OptiBond XTR (K101423). The performance of OptiBond eXTRa Universal in any mode is statistically equivalent to predicate device OptiBond XTR in self-etch mode and does not raise concerns of safety and effectiveness.
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.
Not Found
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
§ 872.3200 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
November 7, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the words "U.S. Food & Drug Administration" on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the words in a sans-serif font.
Kerr Corporation % Ardrena Jackson Senior Regulatory Affairs Specialist Sybron Dental Specialties 1717 W. Collins Ave Orange, California 92867
Re: K182162
Trade/Device Name: OptiBond eXTRa Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: August 8, 2018 Received: August 10, 2018
Dear Ardrena Jackson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Digitally signed by Mary S. Runner -S3 Mary S. Runner -S3 12:56:12 -05'00' For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below
510(k) Number (if known) K182162
Device Name OptiBond eXTRa Universal
Indications for Use (Describe)
Direct Bonding 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 Bonding Applications
- · Veneers.
- · Self-cure, dual-cure, light-cure resin cements and core buildup materials.
- · Porcelain, ceramic (including zirconia-based, lithium disilicate-based and alumina-based), composite, and metal-based (including precious and non-precious metal inlays, onlays, crowns, bridges.
• Endodontic posts.
- · Cavity sealing as a pretreatment for indirect restorations.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510K K182162
Image /page/3/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo consists of the letters "sds" in a stylized font, with a curved line above the letters. Below the letters, the words "Sybron Dental Specialties" are written in a smaller font. The logo is simple and professional, and it is likely used to represent the company's brand.
OptiBond eXTRa Universal
-
- Submitter Information: Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687
| Contact Person: | Ardrena Jackson |
|---|---|
| Telephone Number: | 714-516-7491 |
| Fax Number: | 909-962-5694 |
| Date Prepared: | August 8, 2018 |
-
- Device Name:
| Classification Name | Resin tooth bonding agent |
|---|---|
| FDA CDRH Panel | Dental |
| Product Code | KLE |
| Regulation Number | 872.3200 |
| Class # | II |
-
- Predicate Device: OptiBond XTR (K101423)
-
- Description of Device:
OptiBond eXTRa Universal is a two-component universal adhesive system including a PRIMER and an ADHESIVE. The OptiBond eXTRa Universal PRIMER provides effective etching to enamel and dentin without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure (self-etch technique). OptiBond eXTRa Universal is compatible with total etch and selective etch techniques. The OptiBond eXTRa Universal ADHESIVE is 15% filled with 0.4 micron barium glass to help reinforce bond strength.
-
- Indications for Use:
4
Direct Bonding Applications
- Light-cured composite and compomer restorations. .
- . Composite/ceramic/metal repairs.
- o Cavity sealing for amalgam restorations.
- Sealing of hypersensitive and/or exposed root surfaces. .
- . Core build-ups (self-cured, light-cured, or dual-cured).
Indirect Bonding Applications
- Veneers. .
- . Self-cure, dual-cure, light-cure resin cements and core buildup materials.
- Porcelain, ceramic (including zirconia-based, lithium disilicate-based and . alumina-based), composite, and metal-based (including precious and non-precious metal inlays, onlays, crowns, bridges.
- . Endodontic posts.
- Cavity sealing as a pretreatment for indirect restorations. .
Summary of Non-Clinical Performance Data: 6.
The technological characteristics of subject device OptiBond eXTRa Universal is substantially equivalent to the predicate OptiBond XTR (K101423). Bench testing was conducted on a variety of self-cure or dual-cure resin cements and core-build up materials. The following performance tests were completed during the product lifecycle:
Non-clinical performance data includes testing for shear bond strength to various substrates. The data analyzed from the various tests substantiate that OptiBond eXTRa Universal performs similar to the predicate OptiBond XTR (K101423). The following standards were utilized for non-clinical performance testing of OptiBond eXTRa Universal :
- · ISO 10993-1: 2009 Biological Evaluation of Medical Devices
- · ISO 10993-3:2003 Biological Evaluation of Medical Devices- Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity
- ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in Vitro Cytotoxicity
- · ISO 10993-6:2007 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after Implantation
- ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization
- · ISO 14971:2007 Risk Management
- ISO 29022:2013* Dentistry Adhesive-Notched Edge Sheer Bond Strength TestTesting of Adhesion to Tooth Structure
5
Summary of Technological Characteristics and Device Comparison: 7.
The proposed OptiBond eXTRa Universal has similarities in performance characteristics and design features as compared to the predicate. The nonclinical performance testing demonstrates that the OptiBond eXTRa Universal performs as well as the predicate device OptiBond XTR (K101423). OptiBond eXTRa Universal has been tested for its shear bond strength against a variety of materials (including enamel, dentin, and common substrates) in all etching modes. Additional conformational biocompatibility testing was performed on the proposed OptiBond eXTRa Universal. The first difference in technological characteristics between the two devices is the replacement of one of the monomers in the formulation to another monomer that has the same function. The other difference in technological characteristics is the difference in techniques that the devices are marketed for. While predicate OptiBond XTR is for self-etch techniques, OptiBond eXTRa Universal can also be used in total and selective etch techniques. These technological differences were evaluated by testing the in-vitro shear bond strength of OptiBond eXTRa Universal using all etching techniques and comparing the performance in all modes to the predicate OptiBond XTR. The performance of OptiBond eXTRa Universal in any mode is statistically equivalent to predicate device OptiBond XTR in self-etch mode and does not raise concerns of safety and effectiveness. The differences in the formulation and the differences in application techniques do not raise concerns of safety and effectiveness. and demonstrate the subject device is at least as safe and effective as the legally marketed predicate device.
| Element | Predicate
OptiBond XTR | Subject Device
OptiBond eXTRa Universal |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K101423 | K182162 |
| Manufacturer | Kerr Corporation | Kerr Corporation |
| Trade Name | OptiBond XTR | OptiBond eXTRa Universal |
| Target Users | Licensed Dental Professionals | Licensed Dental Professionals |
| Common Name | Bonding Agent | Same |
| Classification
Name | Resin Tooth Bonding Agent | Same |
| FDA Class | II, 21 CFR 872.3200 | Same |
| Product Code | KLE | Same |
| Device
Description | OptiBond XTR 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 | OptiBond eXTRa Universal is a two-component universal adhesive system including a self-etch PRIMER and a universal ADHESIVE. The OptiBond eXTRa Universal PRIMER provides effective etching to enamel and dentin without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure (self-etch technique). OptiBond |
| Element | Predicate
OptiBond XTR | Subject Device
OptiBond eXTRa Universal |
| | 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 XTR
for their direct procedures without
the need for a secondary bonding
system. | eXTRa Universal is compatible with
total etch and selective etch
techniques. The OptiBond eXTRa
Universal ADHESIVE 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 eXTRa
Universal for their direct and indirect
procedures without the need for a
secondary bonding system. |
| Intended Use | Resin tooth bonding agent used in
direct and indirect bonding
applications | Resin tooth bonding agent used in
direct and indirect bonding
applications |
| Indications for
Use | OptiBond XTR 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 Bonding 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). |
| | 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 Bonding Applications
• Veneers.
• Self-cure, dual-cure, light-cure
resin cements and core buildup
materials.
• Porcelain, ceramic (including
zirconia-based, lithium disilicate-
based and alumina-based),
composite, and metal-based
(including precious and non-precious
metal inlays, onlays, crowns,
bridges.
• Endodontic posts.
• Cavity sealing as a pretreatment for
indirect restorations. |
| | 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 | |
| Element | Predicate
OptiBond XTR | Subject Device
OptiBond eXTRa Universal |
| | | |
| Principles of
Operation | Primer is applied to tooth structure
to etch and prepare the surface,
then adhesive is applied
facilitating adhesion to the
restoration through micro-
mechanical interlocking and
chemical bonding | Same |
| Curing
Mechanism | Photo-initiation | Same |
| Bonding Agent
Type | 2 component system
(primer and adhesive) | Same |
| Technique | Self Etch | Self-etch, Total-etch, Selective-etch |
| Resin Type | methacrylate, GPDM | Same |
| Cure Time | Optilux 501 - 10 seconds
L.E.Demetron I - 10 seconds
L.E.Demetron II - 5 seconds
Demi/Demi Plus/Demi Ultra - 5
seconds
For all other lights see
manufacturer's recommendation. | Same |
| Substrate
Material
Compatibility | Dentin, enamel, composite,
ceramic, metal, amalgam | Same |
| Biocompatibility | Biocompatible per ISO 10993 | Same |
| Storage
conditions | Refrigerate upon receipt, between
2 o - 8oC | Same |
| Shelf Life | 2 years | Same |
| Accessories | Mixing well, applicator brushes | Same |
| Packaging Type
(Delivery
System) | Bottle, Unidose (nonsterile) | Same |
6
7
8
-
- Clinical Performance Data: The company did not conduct clinical performance testing for OptiBond eXTRa Universal.