(164 days)
Direct Applications:
- Light cured composite restorations
- Light cured compomers
- Cavity sealing prior to placement of indirect restorations
- Composite repair of porcelain and hybrid ceramic restorations
- Sealing exposed root surfaces which are causing hypersensitivity
- Core build ups using light cure/dual cure composites
- Protective varnish for glass ionomer (GI) filling
Indirect Applications:
- Cementation indirect restorations
Zipbond is a single-component, (meth)acrylate-based material which functions as a combined etch-and-rinse (total-etch), self-etch and selective-etch dental adhesive. It offers an adhesive application technique for both direct indications and bonds to enamel, dentin, composites, cements. When used with a LED light curing device, Zipbond can be used with self-cure, dual-cure and light cure resin cements, composites and core-build up materials. Zipbond provides the operator with three choices of enamel and dentin pre-treatment: Self-etch mode: no phosphoric acid etching required prior to application, Selective-etch mode: selective phosphoric acid etching to enamel, Total-etch mode: phosphoric acid etching of both enamel and dentin.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Zipbond™ device:
It's important to note that the provided documents are a 510(k) premarket notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically focuses on comparing the new device against the predicate, rather than establishing strict acceptance criteria for a novel technology or conducting extensive standalone performance studies with human readers, as might be done for an AI/software as a medical device (SaMD).
Therefore, some of the requested information (like MRMC studies, specific effect sizes of AI with human readers, or detailed ground truth establishment for large training sets) is not applicable or not explicitly detailed in this type of submission for a dental bonding agent.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device and meeting relevant ISO standards.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (Zipbond™) |
|---|---|
| Equivalence to Predicate Device (Scotchbond Universal Adhesive K110302) | Demonstrated substantial equivalence in intended use, fundamental technology, and similar indications for use. |
| pH measurement (according to internal method) | Satisfactorily met the requirements. (Specific value not provided in this document) |
| Shear bond strength on enamel and dentin (ISO 29022:2013) | Performed similarly to the predicate device. Satisfactorily met the requirements. (Specific bond strength values/comparison not provided in this document, but implied to be equivalent or non-inferior to the predicate.) |
| Biocompatibility (ISO 10993-1 and ISO 7405) | Results of testing and biological risk assessment support substantial equivalence. |
| Physical properties and performance | Satisfactorily met requirements. (Appearance, pH, shear bond strength on various substrates explicitly mentioned) |
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each test (pH, shear bond strength, biocompatibility). These are typically laboratory bench tests, where sample sizes are determined by statistical requirements for each specific test, but not usually presented in the 510(k) summary as "test set sample size" in the context of imaging or AI.
- Data Provenance: The studies are in-vitro bench tests and biocompatibility tests conducted for the purpose of this 510(k) submission. They are prospective tests conducted by SDI Limited. The country of origin of the data would be Australia, where SDI Limited is based.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable in the context of this device and study. For a dental bonding agent, "ground truth" typically refers to physical measurements and standardized test results rather than expert interpretation of medical images or diagnostic outcomes. The "ground truth" for bond strength, pH, or biocompatibility is established by the methods themselves, not by expert consensus.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert-dependent tasks, such as reviewing medical images. For physical and biocompatibility testing of a dental material, the results are typically objectively measured outcomes of the standardized tests.
-
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:
- No. An MRMC comparative effectiveness study is not applicable for a dental bonding agent. This type of study is relevant for evaluating diagnostic imaging software where human readers (e.g., radiologists) use AI assistance to improve their performance. Zipbond™ is a physical dental material, not an AI-powered diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. Zipbond™ is a chemical product (dental bonding agent), not an algorithm or a software device. The "standalone" performance here refers to its efficacy and safety as a product itself, which is what the non-clinical performance data (pH, shear bond strength, biocompatibility) aims to demonstrate.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical performance data is based on objective, standardized laboratory measurements according to established ISO protocols (e.g., ISO 29022:2013 for shear bond strength, ISO 10993-1 and ISO 7405 for biocompatibility) and internal methods (e.g., pH measurement). It is not based on expert consensus, pathology, or outcomes data in the typical sense used for diagnostic devices.
-
The sample size for the training set:
- Not applicable. As Zipbond™ is a dental material and not an AI/machine learning model, there is no "training set" in the context of algorithm development.
-
How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this device.
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December 2, 2019
SDI Limited Ray Cahill Chief Quality and Compliance Officer 3-15 Brunsdon Street Bayswater, 3153 AU
Re: K191656
Trade/Device Name: ZipbondTM Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: September 2, 2019 Received: September 4, 2019
Dear Ray Cahill:
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
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K191656
Device Name
ZIPBOND™
Indications for Use (Describe)
Direct Applications:
- · Light cured composite restorations
- · Light cured compomers
- · Cavity sealing prior to placement of indirect restorations
- · Composite repair of porcelain and hybrid ceramic restorations
- · Sealing exposed root surfaces which are causing hypersensitivity
- · Core build ups using light cure/dual cure composites
- · Protective varnish for glass ionomer (GI) filling
Indirect Applications:
- · Cementation 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) |
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510(k) Summary
For
Zipbond™
1. Submitter Information:
SDI Limited 3-15 Brunsdon Street Bayswater Victoria 3153 Australia
| Contact Person: | Ray Cahill |
|---|---|
| Phone: | +61 3 8727 7111 |
| Fax: | +61 3 8727 7222 |
| Email: | ray.cahill@sdi.com.au |
Date Prepared: 26 November 2019
2. Device Details
| Proprietary Name: | Zipbond™ |
|---|---|
| Common name: | Dental bonding agent |
| Regulation Name: | Resin tooth bonding agent |
| Regulation Number: | 21 CFR 872.3200 |
| Product Code: | KLE |
| Regulatory Class: | II |
3. Predicate device:
| Predicate Device name | 510(k) | Company name |
|---|---|---|
| Scotchbond Universal Adhesive(named as Adhesive EXL 759 in 510k) | K110302 | 3M Espe AG |
4. Device Description:
Zipbond is a single-component, (meth)acrylate-based material which functions as a combined etch-and-rinse (total-etch), self-etch and selective-etch dental adhesive. It offers an adhesive application technique for both direct indications and bonds to enamel, dentin, composites, cements.
When used with a LED light curing device, Zipbond can be used with self-cure, dual-cure and light cure resin cements, composites and core-build up materials. Zipbond provides the operator with three choices of enamel and dentin pre-treatment:
- . Self-etch mode: no phosphoric acid etching required prior to application
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- Selective-etch mode: selective phosphoric acid etching to enamel
- Total-etch mode: phosphoric acid etching of both enamel and dentin
5. Indications of use:
Direct Applications
- Light cured composite restorations
- Light cured compomers
- Cavity sealing prior to placement of indirect restorations
- Composite repair of porcelain and hybrid ceramic restorations
- Sealing exposed root surfaces which are causing hypersensitivity
- · Core build ups using light cure/dual cure composites
- · Protective varnish for glass ionomer (GI) filling
Indirect Applications
- Cementation indirect restorations
6. Substantial equivalence:
Technical characteristics:
| Proposed device:Zipbond, 510K - K191656 | Predicate device:Scotchbond Universal(named as Adhesive EXL759, in 510K - K110302) | Differences: |
|---|---|---|
| Regulation number: | Regulation number: | Differences: |
| 21 CFR 872.3200 | 21 CFR 872.3200 | No differences |
| Product code: | Product code: | Differences: |
| KLE | KLE | No differences |
| Regulatory class: | Regulatory class: | Differences: |
| II | II | No differences |
| Regulation name: | Regulation name: | Differences: |
| Resin tooth bonding agent | Resin tooth bonding agent | No differences |
| Common name: | Common name: | Differences: |
| Dental bonding agent | Dental bonding agent | No differences |
| Intended use: | Intended use: | Differences: |
| Universal dental adhesive | Universal dental adhesive | No differences |
| Composition: | Composition: | Differences: |
| Functional monomers(methacrylates),photoinitiators, stabilisers,silica, ethanol, water,sodium fluoride | Functional monomers(methacrylates),photoinitiators, stabilisers,silica, ethanol, water | Minor – Zipbond UniversalAdhesive contains sodiumfluoride. ScotchbondUniversal does not mentionin their Instructions of Usethat it contains fluoride. |
| Application: | Application: | Differences: |
| Liquid | Liquid | No differences |
| Rx / OTC: | Rx / OTC: | Differences: |
| Rx | Rx | No differences |
| Indications for Usestatement: | Indications for Usestatement: | Differences: |
| Direct Applications:• Light cured compositerestorations• Light cured compomers• Cavity sealing prior toplacement of indirectrestorations• Composite repair ofporcelain and hybridceramic restorations• Sealing exposed rootsurfaces which are causinghypersensitivity• Core build ups using lightcure/dual cure composites• Protective varnish forglass ionomer (GI) fillingIndirect Applications:• Cementation indirectrestorations | • All classes of fillings(according to Black) withlight-curing composite orcompomer filling materials• Cementation of indirectrestorations when combinedwith RelyX UltimateAdhesive Resin Cement,manufactured by 3M ESPE• Cementation of veneerswhen combined with RelyXVeneer Cement,manufacturedby 3M ESPE• Bonding of core build-upsmade of light-curingcomposite or core build-upmaterials• Bonding of dual-curecements and core build-upmaterials and self-curecomposites when combinedwith Scotchbond UniversalDCA• Repair of composite orcompomer fillings• Intraoral repair ofcomposite restorations,porcelain fused to metal, andall-ceramic restorationswithout extra primer• Root surfacedesensitization• Sealing of cavities prior tocementation of amalgamrestorations• Sealing of cavities andpreparation of tooth stumpsprior to temporarycementation of indirectrestorations• Bonding of fissure sealants• Protective varnish for glassionomer fillings | Minor – Zipbond is not usedwith a dual-cure activator,and requires light curingbefore placement of dual-cure cements, core build upmaterials and self-curecomposites. |
| Indications for Use: | Indications for Use: | Differences: |
| Light cured compositerestorations | All classes of fillings(according to Black) withlight-curing composite orcompomer filling materials | No differences – classes offillings according to Blackinclude direct restorations |
| Light cured compomers | Cementation of veneerswhen combined with RelyXVeneer Cement,manufacturedby 3M ESPE | |
| Cavity sealing prior toplacement of indirectrestorations | Sealing of cavities prior tocementation of amalgamrestorations | No differences – sealing ofcavities prior to placementof indirect restorations |
| Sealing of cavities andpreparation of tooth stumpsprior to temporarycementation of indirectrestorations | ||
| Composite repair ofporcelain and hybridceramic restorations | Intraoral repair of compositerestorations, porcelain fusedto metal, andall-ceramic restorationswithout extra primerRepair of composite orcompomer fillings | No differences- Zipbondhybrid ceramic restorationsinclude porcelain fused tometal. |
| Sealing exposed rootsurfaces which are causinghypersensitivity | Root surface desensitization | No differences – sealingroot surfaces results indesensitization |
| Core build ups using lightcure/dual cure composites | Bonding of core build-upsmade of light-curingcomposite or core build-upmaterials | Minor indication – predicatedevice ScotchbondUniversal is used with adual cure activator whenbonding with dual-curecements, core build-up |
| Bonding of dual-curecements and core build-upmaterials and self-curecomposites when combinedwith Scotchbond UniversalDCA | materials and self-curecomposites, whereassubject device Zipbond isnot used with a dual cureactivator and is to be priorlight cured when bonding tothese materials. | |
| Protective varnish for glassionomer (GI) filling | Protective varnish for glassionomer fillings | No differences |
| Cementation indirectrestorations | Cementation of indirectrestorations when combinedwith RelyX UltimateAdhesive Resin Cement,manufactured by 3M ESPE | No differences – predicatedevice ScotchbondUniversal indicationdescribes the compatibilityof the dental adhesive witha specific resin cement,RelyX Ultimate AdhesiveResin Cement.The adhesive bonds theindirect substrate to theprepared tooth cavity. Thetooth cavity mayincorporate a luting cement,based on the substratemanufacturer's Instructionsfor Use. |
| Light cured composite | Bonding of fissure sealants | No differences - fissure is asmall dental cavity which |
| can be filled by a light-curedcomposite. | ||
| Features: | Features: | Differences: |
| Single-component, lightcuring universal adhesive | Single-component, lightcuring adhesive | No differences |
| Self-etch, selective etch (toenamel), or total etchtechniques | Self-etch, selective enameletch, or total etch techniques | No differences |
| Light-curing universaladhesive | Light-curing universaladhesive used withoutseparate Activator for | Both are light-curingadhesive systems. |
| No dual-cure activator | assigned materials(reference cements). | Predicate deviceScotchbond Universal usesa dual-cure activator when |
| Use with separate dual-cureActivator for use with dual-cure cement, core build upmaterials and self cure | bonding of dual-curecements and core build-upmaterials, and self curecomposites. | |
| composites. | Subject device Zipbonddoes not use a dual-cureactivator and requires priorlight curing when bonding to | |
| dual-cure cements, corebuild-up materials and selfcure composites. |
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Subject device Zipbond and predicate device Scotchbond Universal share the same technological characteristics – both are composed of functional monomers (methacrylates), photoinitiators, stabilisers, silica, ethanol, water. Zipbond also contains sodium fluoride as a fluoride source. Both devices are light-curing dental adhesives using the self-etch, selective enamel etch, or total etch techniques. Predicate device Scotchbond Universal can be used with a dual-cure activator when bonding to dual-cure cements, core build-up materials, and self cure composites, whereas subject device Zipbond requires prior light curing to bond to these materials. Both devices performed similarly for shear bond strength according to ISO 29022:2013-Dentistry – Adhesion - Notched-edge Shear Bond Strength Test.
7.Non-Clinical Performance Data:
The following in-vitro bench tests were performed on Zipbond to verify physical properties and performance in support of substantial equivalence:
- . pH measurement according to internal method
- Shear bond strength on enamel and dentin according to ISO 29022:2013-Dentistry-● Adhesion-Notched edge shear bond strength test.
The performance of Zipbond satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.
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Biocompatibility testing was conducted according to ISO 10993-1 - Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and ISO 7405- Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
The results of the biocompatibility testing and biological risk assessment conducted relating to the subject device Zipbond support its substantial equivalence.
8. Conclusion Regarding Substantial Equivalence:
Zipbond has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate device Scotchbond Universal. Test data to verify physical properties and the performance of Zipbond has been provided including: appearance, pH, shear bond strength on various substrates. The results of the testing, combined with the design and indications for use comparison with predicate device Scotchbond Universal support substantial equivalence.
§ 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.