(164 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a dental adhesive, with no mention of AI or ML.
No
The device, Zipbond, is a dental adhesive used for bonding restorations and sealing surfaces, not for treating diseases or conditions. Its intended uses are restorative and protective, not therapeutic.
No
The device description indicates that Zipbond is a dental adhesive used for bonding materials and sealing surfaces, not for diagnosing conditions or diseases. Its applications are related to the treatment and restoration of dental structures.
No
The device description clearly states it is a "(meth)acrylate-based material" and a "single-component" substance, indicating it is a physical material (a dental adhesive) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that Zipbond is a dental adhesive used for bonding dental materials to tooth structures (enamel, dentin, root surfaces). It is applied directly to the patient's teeth during dental procedures.
- Intended Use: The intended uses are all related to dental restorations and procedures performed directly on the patient's teeth.
- Anatomical Site: The anatomical sites listed are all parts of the tooth.
- Lack of Specimen Analysis: There is no mention of analyzing any specimens taken from the body.
Therefore, Zipbond is a dental device used for direct application within the oral cavity, not for in vitro diagnostic testing of specimens.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
KLE
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
- Selective-etch mode: selective phosphoric acid etching to enamel
- Total-etch mode: phosphoric acid etching of both enamel and dentin
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth (Enamel, Dentin, Root surfaces, Cavities, Fissures)
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)
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.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
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
4
- 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 EXL
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
(methacrylates),
photoinitiators, stabilisers,
silica, ethanol, water,
sodium fluoride | Functional monomers
(methacrylates),
photoinitiators, stabilisers,
silica, ethanol, water | Minor – Zipbond Universal
Adhesive contains sodium
fluoride. Scotchbond
Universal does not mention
in their Instructions of Use
that it contains fluoride. |
| Application: | Application: | Differences: |
| Liquid | Liquid | No differences |
| Rx / OTC: | Rx / OTC: | Differences: |
| Rx | Rx | No differences |
| Indications for Use
statement: | Indications for Use
statement: | Differences: |
| 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 | • All classes of fillings
(according to Black) with
light-curing composite or
compomer filling materials
• Cementation of indirect
restorations when combined
with RelyX Ultimate
Adhesive Resin Cement,
manufactured by 3M ESPE
• Cementation of veneers
when combined with RelyX
Veneer Cement,
manufactured
by 3M ESPE
• Bonding of core build-ups
made of light-curing
composite or core build-up
materials
• Bonding of dual-cure
cements and core build-up
materials and self-cure
composites when combined
with Scotchbond Universal
DCA
• Repair of composite or
compomer fillings
• Intraoral repair of
composite restorations,
porcelain fused to metal, and
all-ceramic restorations
without extra primer
• Root surface
desensitization
• Sealing of cavities prior to
cementation of amalgam
restorations
• Sealing of cavities and
preparation of tooth stumps
prior to temporary
cementation of indirect
restorations
• Bonding of fissure sealants
• Protective varnish for glass
ionomer fillings | Minor – Zipbond is not used
with a dual-cure activator,
and requires light curing
before placement of dual-
cure cements, core build up
materials and self-cure
composites. |
| Indications for Use: | Indications for Use: | Differences: |
| Light cured composite
restorations | All classes of fillings
(according to Black) with
light-curing composite or
compomer filling materials | No differences – classes of
fillings according to Black
include direct restorations |
| Light cured compomers | Cementation of veneers
when combined with RelyX
Veneer Cement,
manufactured
by 3M ESPE | |
| | | |
| Cavity sealing prior to
placement of indirect
restorations | Sealing of cavities prior to
cementation of amalgam
restorations | No differences – sealing of
cavities prior to placement
of indirect restorations |
| | Sealing of cavities and
preparation of tooth stumps
prior to temporary
cementation of indirect
restorations | |
| Composite repair of
porcelain and hybrid
ceramic restorations | Intraoral repair of composite
restorations, porcelain fused
to metal, and
all-ceramic restorations
without extra primer
Repair of composite or
compomer fillings | No differences- Zipbond
hybrid ceramic restorations
include porcelain fused to
metal. |
| Sealing exposed root
surfaces which are causing
hypersensitivity | Root surface desensitization | No differences – sealing
root surfaces results in
desensitization |
| Core build ups using light
cure/dual cure composites | Bonding of core build-ups
made of light-curing
composite or core build-up
materials | Minor indication – predicate
device Scotchbond
Universal is used with a
dual cure activator when
bonding with dual-cure
cements, core build-up |
| | Bonding of dual-cure
cements and core build-up
materials and self-cure
composites when combined
with Scotchbond Universal
DCA | materials and self-cure
composites, whereas
subject device Zipbond is
not used with a dual cure
activator and is to be prior
light cured when bonding to
these materials. |
| Protective varnish for glass
ionomer (GI) filling | Protective varnish for glass
ionomer fillings | No differences |
| Cementation indirect
restorations | Cementation of indirect
restorations when combined
with RelyX Ultimate
Adhesive Resin Cement,
manufactured by 3M ESPE | No differences – predicate
device Scotchbond
Universal indication
describes the compatibility
of the dental adhesive with
a specific resin cement,
RelyX Ultimate Adhesive
Resin Cement.
The adhesive bonds the
indirect substrate to the
prepared tooth cavity. The
tooth cavity may
incorporate a luting cement,
based on the substrate
manufacturer's Instructions
for Use. |
| Light cured composite | Bonding of fissure sealants | No differences - fissure is a
small dental cavity which |
| | | |
| | | can be filled by a light-cured
composite. |
| Features: | Features: | Differences: |
| Single-component, light
curing universal adhesive | Single-component, light
curing adhesive | No differences |
| Self-etch, selective etch (to
enamel), or total etch
techniques | Self-etch, selective enamel
etch, or total etch techniques | No differences |
| Light-curing universal
adhesive | Light-curing universal
adhesive used without
separate Activator for | Both are light-curing
adhesive systems. |
| No dual-cure activator | assigned materials
(reference cements). | Predicate device
Scotchbond Universal uses
a dual-cure activator when |
| | Use with separate dual-cure
Activator for use with dual-
cure cement, core build up
materials and self cure | bonding of dual-cure
cements and core build-up
materials, and self cure
composites. |
| | composites. | Subject device Zipbond
does not use a dual-cure
activator and requires prior
light curing when bonding to |
| | | dual-cure cements, core
build-up materials and self
cure composites. |
5
6
7
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.
8
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.