(115 days)
Not Found
No
The summary describes a chemical bonding agent and does not mention any computational or data-driven components that would suggest the use of AI or ML.
No.
The device is a universal bonding agent for dental restorations, not a therapeutic device designed for treatment or healing.
No
The device is a universal bonding agent intended to bond dental restorative materials; it does not diagnose medical conditions.
No
The device description clearly states it is a "single-component universal dental adhesive," which is a chemical substance, not software. The performance studies also focus on physical and biological properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "universal bonding agent intended to bond methacrylate-based restorative materials, cements and sealants to dentin, enamel, and various indirect restorative substrates." This describes a material used in the body for dental restoration, not a device used outside the body to examine specimens derived from the human body.
- Device Description: The description reinforces that it's a "single-component universal dental adhesive intended for direct and indirect dental restorations." Again, this points to a material used in dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological specimens (blood, urine, tissue, etc.) or to provide information about a patient's health status, disease, or condition based on such analysis.
- Performance Studies: The performance studies focus on bond strength, biocompatibility, and shelf-life, which are relevant to a dental adhesive used in the mouth, not an IVD.
- Predicate Device: The predicate device is also a dental adhesive, further supporting that this device falls under the category of dental materials/devices used in the body.
In summary, the function and intended use of Rainbow 360 are consistent with a dental adhesive used for bonding materials within the oral cavity, which is not the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Direct Applications
- · Light-cure, self-cure and dual cure composite and compomer restorations.
- · Composite/ceramic/metal repairs.
- Tooth preparation and root surface sealer.
- · Cavity sealing for amalgam restorations.
- · Light-cured or dual-cured core build-ups.
- · Bonding of methacrylate-based fissure sealants.
Indirect Applications
- · Cementation of veneers
- · Cementation of porcelain, composite, and metal-based restorations
- · Cementation of endodontic posts
- · Cavity sealing as a pretreatment for indirect restorations.
- · Prime metal, ceramic, and composite substrates/restorations.
Product codes
KLE
Device Description
The subject device, Rainbow 360, is a single-component universal dental adhesive intended for direct and indirect dental restorations. Rainbow 360 is formulated to provide reliable bond strengths with any etch technique, on all common substrates and in combination with any resin cements without auxiliary products (silane or metal primers) even in absence of light. Rainbow 360 is available in bottles for multiple uses and Unidose™ for single use. Rainbow 360 is intended for general population use by a dental professional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional
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)
Kerr conducted design verification performance testing to verify, demonstrate and support the claim of substantial equivalence to the predicate device. All test results met their acceptance criteria and support that the Rainbow 360 is appropriately designed for their intended use.
Kerr conducted design verification performance testing according to the FDA recognized/ voluntary consensus standards and quidelines.
- . ISO 29022:2013, "Dentistry - Adhesive - Notched-edge sheer bond strength test"
- ASTM D4169:2016, "Standard Practice for Performance Testing of Shipping ● Containers and Systems"
Biocompatibility assessments were conducted in accordance with ISO-10993-1:2018, "Biological evaluation of medical devices - part 1: Evaluation and testing within a risk management process", U.S. Food and Drug Administration (FDA) Guidance Document for the Use of ISO 10993-1 (issued 09/04/2020) quidelines and ISO 7405:2018 "Dentistry -Evaluation of biocompatibility of medical devices used in dentistry" as guidance. Kerr performed the biocompatibility testing of the finished product according to the following parts of the ISO 10993 and ISO 7405 standard.
- ISO 7405:2018, "Dentistry Evaluation of biocompatibility of medical devices . used in dentistry"
- ISO 10993-2:2006, "Biological evaluation of medical devices part 2: Animal ● welfare requirements"
- ISO 10993-3:2014, "Biological evaluation of medical devices part 3: Tests for ● genotoxicity, carcinogenicity and reproductive"
- ISO 10993-5:2009, "Biological evaluation of medical devices part 5: Tests for in ● vitro cvtotoxicity"
- ISO 10993-6:2016, "Biological evaluation of medical devices part 6: Tests for . local effects after implantation"
- ISO 10993-10:2021, ● irritation and delayed-type hypersensitivity"
- ISO 10993-11:2017, "Biological evaluation of medical devices Part 11: Tests for ● systemic toxicity"
- . ISO 10993-12:2021, "Biological evaluation of medical devices- part 12: Sample preparation and reference materials"
- ISO 10993-23:2021, ● irritation"
In addition to the above testing performed according to the ISO standards, the following internal performance testing was also conducted: - . Shelf-life testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ADH19 (K192961)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 12, 2023
Kerr Corporation Viviana Lai Principal Specialist, Regulatory Affairs 1889 W Mission Blvd Pomona, California 91766
Re: K222830
Trade/Device Name: Rainbow 360 Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: October 14, 2022 Received: October 14, 2022
Dear Viviana Lai:
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.
1
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 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 mediation-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.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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
Indications for Use
510(k) Number (if known) K222830
Device Name Rainbow 360
Indications for Use (Describe)
Direct Applications
- · Light-cure, self-cure and dual cure composite and compomer restorations.
- · Composite/ceramic/metal repairs.
- Tooth preparation and root surface sealer.
- · Cavity sealing for amalgam restorations.
- · Light-cured or dual-cured core build-ups.
- · Bonding of methacrylate-based fissure sealants.
Indirect Applications
- · Cementation of veneers
- · Cementation of porcelain, composite, and metal-based restorations
- · Cementation of endodontic posts
- · Cavity sealing as a pretreatment for indirect restorations.
- · Prime metal, ceramic, and composite substrates/restorations.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Exploration Use (43 CFR 3809 Subpart B) | □ Casual Use (43 CFR 3809 Subpart A) |
|---|---|
| ------------------------------------------------------------------------------------ | -------------------------------------- |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the word "Kerr" in a bold, sans-serif font. The word is a dark blue color. There is a trademark symbol to the right of the word. The word is the logo for Kerr Corporation, a dental supply company.
510(k) Summary
Submitter Information:
Kerr Corporation
1889 W Mission Blvd Pomona, CA 91766 USA
| Contact Person: | Viviana Lai |
|---|---|
| Telephone Number: | (714) 516-7760 |
| Email: | Viviana.lai@envistaco.com |
Date Prepared: December 21, 2022
Device Name:
| Proprietary Name: | Rainbow 360 |
|---|---|
| Manufacturer: | Kerr Corporation |
| Common Name: | Resin Tooth Bonding Agent |
| Classification Name: | Resin Tooth Bonding Agent |
| CFR Number: | 21 CFR 872.3200 |
| Device Class: | II |
| Product Code: | KLE |
Predicate Device:
| Proprietary Name: | ADH19 (K192961) |
|---|---|
| Manufacturer: | 3M Deutschland GmbH |
| Common Name: | Resin Tooth Bonding Agent |
| Classification Name: | Resin Tooth Bonding Agent |
| CFR Number: | 21 CFR 872.3200 |
| Device Class: | II |
| Product Code: | KLE |
Description of Device:
The subject device, Rainbow 360, is a single-component universal dental adhesive intended for direct and indirect dental restorations. Rainbow 360 is formulated to provide reliable bond strengths with any etch technique, on all common substrates and in combination with any resin cements without auxiliary products (silane or metal primers) even in absence of light. Rainbow 360 is available in bottles for multiple uses and Unidose™ for single use. Rainbow 360 is intended for general population use by a dental professional.
4
Image /page/4/Picture/0 description: The image shows the word "Kerr" in a bold, sans-serif font. The word is a dark blue color. There is a trademark symbol in the upper right corner of the word. The background is white.
Principle of Operation / Mechanism of Action:
Rainbow 360 contains an acidic component to etch the tooth surface in order to allow the adhesive to mechanically adhere to the prepared tooth surface. The adhesive can be used with light or without light curing prior to application of the restorative material. This allows for the adhesive to mechanically and chemically bond to the applied restorative material. Rainbow 360 is formulated to provide a reliable bond strength, and it's compatible with all etching modes (self-etch, selective etch, and total etch).
Indications for Use:
Direct Applications
- Light-cured, self-cured and dual-cured composite and compomer restorations.
- Composite/ceramic/metal repairs. ●
- Tooth preparation and root surface sealer. ●
- Cavity sealing for amalgam restorations. ●
- Light-cured or dual-cured core build-ups. .
- Bonding of methacrylate-based fissure sealants. ●
Indirect Applications
- Cementation of veneers ■
- I Cementation of porcelain, composite, and metal-based restorations
- Cementation of endodontic posts ■
- Cavity sealing as a pretreatment for indirect restorations.
- Prime metal, ceramic, and composite substrates/restorations. ●
Description of Substantial Equivalence:
Table 5-1 below compares the Rainbow 360 to the Predicate device (Adh19 aka 3M™ Scotchbond™ Universal Plus (K192961)) with respect to intended use, technological characteristics, and performance testing.
Details of the Similarities between the Subject and Predicate Devices:
Rainbow 360 and the predicate device have the same intended use and similar indication for use.
The delivery system is identical between both devices as a one-component dental adhesive.
5
Image /page/5/Picture/0 description: The image shows the word "Kerr" in a bold, sans-serif font. The word is a dark blue color. A trademark symbol is located to the right of the word.
The technological principle for both the subject and predicate devices is to bond methacrylate-based restorative materials, cement and sealants to dentin, enamel, and various indirect restoratives with all etching techniques - total-etch, self-etch and selective etch used for direct and indirect indications.
Details of the differences between the Subject and Predicate Devices:
There are no major differences between the subject device (Rainbow 360) and the predicate device (Adh19, K192961), however, there are some minor differences between the two devices.
There is an additional indication for use in the predicate device for protective varnish for glass ionomer fillings in direct application. This particular indication for use is not applied to the subject device, Rainbow 360. The chemical composition is slightly different between the two devices as well as the configuration.
Conclusion:
Based on a comparison of intended use, indications for use, technological characteristics, the principle of operation, features, and performance data, the Rainbow 360 is deemed to be substantially equivalent to the Predicate Device as it satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: Indications for Use, Technological Characteristics, and Performance Data. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantially equivalent.
| Descriptive
Information | Subject Device
Rainbow 360 | Predicate Device
Adh19 (K192961) | Comparison |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Pictorial
Representation | Image: Rainbow 360 | Image: Adh19 (K192961) | N/A |
| Regulation Number | 21 CFR 872.3200 | 21 CFR 872.3200 | Same as Predicate |
| Regulation Title | Resin tooth bonding agent | Resin tooth bonding agent | Same as Predicate |
| Regulation Class | II | II | Same as Predicate |
| Product Code | KLE | KLE | Same as Predicate |
| Descriptive
Information | Subject Device
Rainbow 360 | Predicate Device
Adh19 (K192961) | Comparison |
| Indications for Use | Direct Applications
• Light-cured, self-cured and dual-
cured composite and compomer
restorations.
• Composite/ceramic/metal repairs.
• Tooth preparation and root
surface sealer.
• Cavity sealing for amalgam
restorations.
• Light-cured or dual-cured core
build-ups.
• Bonding of methacrylate-based
fissure sealants.
Indirect Applications
• Cementation of veneers
• Cementation of porcelain,
composite, and metal-based
restorations
• Cementation of endodontic posts
• Cavity sealing as a pretreatment
for indirect restorations.
• Prime metal, ceramic, and
composite substrates /
restorations. | Direct Indications
• Bonding for all methacrylate-
based light-, dual-, and self-
cure composite or compomer
filling materials
• Root surface desensitization
• Bonding of methacrylate-based
fissure sealants
• Protective varnish for glass
ionomer fillings
• Repair of composite and
compomer fillings
• Sealing of cavities prior to
placement of amalgam
restorations
Indirect Indications:
• Cementation of indirect
restorations in combination
with Suglue 3 and other resin
cements (follow applicable
Instructions for Use)
• Bonding for all methacrylate-
based light-, self-, and dual-
cure core build-up materials
and cements
• Cementation of veneers when
combined with RelyX Veneer
Cement
• Intraoral repair of composite
restorations, porcelain fused to
metal, and all-ceramic
restorations without extra
primer
• Sealing of cavities and
preparation of tooth stumps
prior to temporary cementation
of indirect restorations | Same Indication for
Use as Predicate and
expressed through a
similar choice of
words. |
| Intended Use | Rainbow 360 is a universal bonding
agent intended to bond
methacrylate-based restorative
materials, cements and sealants to
dentin, enamel, and various indirect
restorative substrates. It can be used
in a self-etch mode, selective etch
mode or in a total-etch mode for
both direct and indirect dental
restorative procedures. | A material primarily intended to be
used as a bonding-promoting
substance between tooth substance
and dental restorations. It may also
be used as a dentin sealant and as
a bonding agent for repair of
restorations.
Intended to bond methacrylate-
based restorative, cement and
sealant materials to dentin, enamel,
glass ionomer and various indirect
restorative substrates (metals,
glass ceramics, alumina, and
zirconia). The primary use will be
with light cured materials and it will
have the capability to also bond | Same intended use as
Predicate and
expressed through a
similar choice of
words. |
| | | self- or dual-cure composite and
cement materials. | |
| Descriptive
Information | Subject Device
Rainbow 360 | Predicate Device
Adh19 (K192961) | Comparison |
| Composition | Phosphoric acid modified
methacrylate, monofunctional
methacrylate, difunctional
methacrylate, acidic methacrylate,
water, ethanol, acetone, initiator,
stabilizer, and silica filler. | MDP Phosphate Monomer, HEMA,
3M™ Vitrebond™ Copolymer, Filler,
Ethanol, water, initiators, silane,
and Dimethacrylate resins. | Similar as Predicate |
| One-component
dental adhesive | One-component dental adhesive | One-component dental adhesive | Same as Predicate |
| Configurations | 5ml bottle for multiple uses
0.18 ml Unidose for single use | 5ml Vial
0.11 ml Unit Dose | Similar as Predicate |
| Single Use | Yes | Yes | Same as Predicate |
| Non-Sterile | Yes | Yes | Same as Predicate |
| Technological Characteristics | | | |
| Workflow/Technique | Self-etch, selective etch, and total
etch | Self-etch, selective etch, and total
etch | Same as Predicate |
| Substrate's
compatibility | Dentin, enamel, composite, metal,
porcelain/ceramic substrates | Dentin, enamel, resin, compomer,
metal, ceramic substrates | Same as Predicate |
| Cements
compatibility | Compatible with resin cements | Compatible with resin cements | Same as Predicate |
| Shelf life | 2 years | 2 years | Same as Predicate |
| Performance Testing | | | |
| Bond strength test | ISO 29022 | ISO 29022 | Same as Predicate |
| Biocompatibility
testing | Biocompatible per ISO 10993-1 and
ISO 7405 | Biocompatible per ISO 10993-1 and
ISO 7405 | Same as Predicate |
Table 5-1 Device Comparison Table:
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Image /page/6/Picture/0 description: The image features the word "Kerr" in a bold, blue font. The font appears to be sans-serif. There is a trademark symbol to the right of the word.
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Image /page/7/Picture/0 description: The image shows the logo for Kerr. The logo is a simple, sans-serif typeface with the word "Kerr" in a dark blue color. The letters are bold and slightly rounded, giving the logo a modern and professional look. There is a trademark symbol in the upper right corner of the logo.
Non-Clinical Test Data:
Kerr conducted design verification performance testing to verify, demonstrate and support the claim of substantial equivalence to the predicate device. All test results met their acceptance criteria and support that the Rainbow 360 is appropriately designed for their intended use.
Kerr conducted design verification performance testing according to the FDA recognized/ voluntary consensus standards and quidelines.
- . ISO 29022:2013, "Dentistry - Adhesive - Notched-edge sheer bond strength test"
- ASTM D4169:2016, "Standard Practice for Performance Testing of Shipping ● Containers and Systems"
Biocompatibility
Biocompatibility assessments were conducted in accordance with ISO-10993-1:2018, "Biological evaluation of medical devices - part 1: Evaluation and testing within a risk management process", U.S. Food and Drug Administration (FDA) Guidance Document for the Use of ISO 10993-1 (issued 09/04/2020) quidelines and ISO 7405:2018 "Dentistry -Evaluation of biocompatibility of medical devices used in dentistry" as guidance. Kerr performed the biocompatibility testing of the finished product according to the following parts of the ISO 10993 and ISO 7405 standard.
8
Image /page/8/Picture/0 description: The image shows the word "Kerr" in a bold, sans-serif font. The word is a dark blue color, and there is a trademark symbol to the right of the second "r". The background is white.
- ISO 7405:2018, "Dentistry Evaluation of biocompatibility of medical devices . used in dentistry"
- ISO 10993-2:2006, "Biological evaluation of medical devices part 2: Animal ● welfare requirements"
- ISO 10993-3:2014, "Biological evaluation of medical devices part 3: Tests for ● genotoxicity, carcinogenicity and reproductive"
- ISO 10993-5:2009, "Biological evaluation of medical devices part 5: Tests for in ● vitro cvtotoxicity"
- ISO 10993-6:2016, "Biological evaluation of medical devices part 6: Tests for . local effects after implantation"
- ISO 10993-10:2021, ● irritation and delayed-type hypersensitivity"
- ISO 10993-11:2017, "Biological evaluation of medical devices Part 11: Tests for ● systemic toxicity"
- . ISO 10993-12:2021, "Biological evaluation of medical devices- part 12: Sample preparation and reference materials"
- ISO 10993-23:2021, ● irritation"
In addition to the above testing performed according to the ISO standards, the following internal performance testing was also conducted:
- . Shelf-life testing
Clinical Performance Data:
Clinical data is not required to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product.
Conclusion as to Substantial Equivalence:
Based on a comparison of intended use, indications, material composition, technological characteristics, principle of operation, features and performance data, the Rainbow 360 is deemed to be substantially equivalent to the predicate device.