Zipbond

K191656 · Sdi Limited · KLE · Dec 2, 2019 · Dental

Device Facts

• Record ID: K191656
• Device Name: Zipbond
• Applicant: Sdi Limited
• Product Code: KLE · Dental
• Decision Date: Dec 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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

Device Story

Zipbond is a single-component, (meth)acrylate-based dental adhesive used by dentists in clinical settings. It functions as a bonding agent for direct and indirect dental restorations. The device is applied to enamel, dentin, composites, or cements and requires activation via an external LED light curing device. It supports three pre-treatment techniques: self-etch, selective-etch, and total-etch. By creating a bond between the tooth structure and restorative materials, it facilitates the placement of fillings, core build-ups, and indirect restorations, and helps treat hypersensitivity by sealing exposed root surfaces. The inclusion of sodium fluoride provides a fluoride source. The clinician applies the liquid adhesive, then light-cures it before placing the restorative material. This process ensures stable adhesion, improving the longevity and success of dental restorations.

Clinical Evidence

Bench testing only. Performance verified via in-vitro testing including pH measurement and shear bond strength on enamel and dentin per ISO 29022:2013. Biocompatibility evaluated per ISO 10993-1 and ISO 7405. Results demonstrate performance equivalent to the predicate.

Technological Characteristics

Single-component (meth)acrylate-based liquid adhesive. Composition: functional monomers, photoinitiators, stabilizers, silica, ethanol, water, sodium fluoride. Energy source: external LED light curing device. Application: self-etch, selective-etch, or total-etch techniques. Sterilization: not applicable (non-sterile dental material).

Indications for Use

Indicated for direct restorations (composite/compomer), cavity sealing, repair of porcelain/hybrid ceramic restorations, root surface desensitization, core build-ups, protective varnish for glass ionomer, and cementation of indirect restorations.

Regulatory Classification

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.

Predicate Devices

• Scotchbond Universal Adhesive (K110302)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 ( <i>Select one or both, as applicable</i> ) |
|------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |

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<br>(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:<br>Zipbond, 510K - K191656 | Predicate device:<br>Scotchbond Universal<br>(named as Adhesive EXL<br>759, 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<br>(methacrylates),<br>photoinitiators, stabilisers,<br>silica, ethanol, water,<br>sodium fluoride | Functional monomers<br>(methacrylates),<br>photoinitiators, stabilisers,<br>silica, ethanol, water | Minor – Zipbond Universal<br>Adhesive contains sodium<br>fluoride. Scotchbond<br>Universal does not mention<br>in their Instructions of Use<br>that it contains fluoride. |
| Application: | Application: | Differences: |
| Liquid | Liquid | No differences |
| Rx / OTC: | Rx / OTC: | Differences: |
| Rx | Rx | No differences |
| Indications for Use<br>statement: | Indications for Use<br>statement: | Differences: |
| Direct Applications:<br>• Light cured composite<br>restorations<br>• Light cured compomers<br>• Cavity sealing prior to<br>placement of indirect<br>restorations<br>• Composite repair of<br>porcelain and hybrid<br>ceramic restorations<br>• Sealing exposed root<br>surfaces which are causing<br>hypersensitivity<br>• Core build ups using light<br>cure/dual cure composites<br>• Protective varnish for<br>glass ionomer (GI) filling<br><br>Indirect Applications:<br>• Cementation indirect<br>restorations | • All classes of fillings<br>(according to Black) with<br>light-curing composite or<br>compomer filling materials<br>• Cementation of indirect<br>restorations when combined<br>with RelyX Ultimate<br>Adhesive Resin Cement,<br>manufactured by 3M ESPE<br>• Cementation of veneers<br>when combined with RelyX<br>Veneer Cement,<br>manufactured<br>by 3M ESPE<br>• Bonding of core build-ups<br>made of light-curing<br>composite or core build-up<br>materials<br>• Bonding of dual-cure<br>cements and core build-up<br>materials and self-cure<br>composites when combined<br>with Scotchbond Universal<br>DCA<br>• Repair of composite or<br>compomer fillings<br>• Intraoral repair of<br>composite restorations,<br>porcelain fused to metal, and<br>all-ceramic restorations<br>without extra primer<br>• Root surface<br>desensitization<br>• Sealing of cavities prior to<br>cementation of amalgam<br>restorations<br>• Sealing of cavities and<br>preparation of tooth stumps<br>prior to temporary<br>cementation of indirect<br>restorations<br>• Bonding of fissure sealants<br>• Protective varnish for glass<br>ionomer fillings | Minor – Zipbond is not used<br>with a dual-cure activator,<br>and requires light curing<br>before placement of dual-<br>cure cements, core build up<br>materials and self-cure<br>composites. |
| Indications for Use: | Indications for Use: | Differences: |
| Light cured composite<br>restorations | All classes of fillings<br>(according to Black) with<br>light-curing composite or<br>compomer filling materials | No differences – classes of<br>fillings according to Black<br>include direct restorations |
| Light cured compomers | Cementation of veneers<br>when combined with RelyX<br>Veneer Cement,<br>manufactured<br>by 3M ESPE | |
| | | |
| Cavity sealing prior to<br>placement of indirect<br>restorations | Sealing of cavities prior to<br>cementation of amalgam<br>restorations | No differences – sealing of<br>cavities prior to placement<br>of indirect restorations |
| | Sealing of cavities and<br>preparation of tooth stumps<br>prior to temporary<br>cementation of indirect<br>restorations | |
| Composite repair of<br>porcelain and hybrid<br>ceramic restorations | Intraoral repair of composite<br>restorations, porcelain fused<br>to metal, and<br>all-ceramic restorations<br>without extra primer<br>Repair of composite or<br>compomer fillings | No differences- Zipbond<br>hybrid ceramic restorations<br>include porcelain fused to<br>metal. |
| Sealing exposed root<br>surfaces which are causing<br>hypersensitivity | Root surface desensitization | No differences – sealing<br>root surfaces results in<br>desensitization |
| Core build ups using light<br>cure/dual cure composites | Bonding of core build-ups<br>made of light-curing<br>composite or core build-up<br>materials | Minor indication – predicate<br>device Scotchbond<br>Universal is used with a<br>dual cure activator when<br>bonding with dual-cure<br>cements, core build-up |
| | Bonding of dual-cure<br>cements and core build-up<br>materials and self-cure<br>composites when combined<br>with Scotchbond Universal<br>DCA | materials and self-cure<br>composites, whereas<br>subject device Zipbond is<br>not used with a dual cure<br>activator and is to be prior<br>light cured when bonding to<br>these materials. |
| Protective varnish for glass<br>ionomer (GI) filling | Protective varnish for glass<br>ionomer fillings | No differences |
| Cementation indirect<br>restorations | Cementation of indirect<br>restorations when combined<br>with RelyX Ultimate<br>Adhesive Resin Cement,<br>manufactured by 3M ESPE | No differences – predicate<br>device Scotchbond<br>Universal indication<br>describes the compatibility<br>of the dental adhesive with<br>a specific resin cement,<br>RelyX Ultimate Adhesive<br>Resin Cement.<br>The adhesive bonds the<br>indirect substrate to the<br>prepared tooth cavity. The<br>tooth cavity may<br>incorporate a luting cement,<br>based on the substrate<br>manufacturer's Instructions<br>for Use. |
| Light cured composite | Bonding of fissure sealants…