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.

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.

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.

AI/ML Overview

The provided text describes the 510(k) summary for the "Rainbow 360" dental bonding agent. This document focuses on demonstrating substantial equivalence to a predicate device (ADH19 / 3M™ Scotchbond™ Universal Plus (K192961)) rather than proving the device meets specific acceptance criteria through a clinical study with human-in-the-loop performance, as might be done for an AI/ML-based diagnostic device.

Therefore, many of the requested criteria (e.g., expertise of ground truth adjudicators, MRMC study, training set details) are not applicable to this type of device submission, which relies on non-clinical performance and biocompatibility testing for substantial equivalence.

However, I can extract the relevant information regarding acceptance criteria and the non-clinical studies performed.

Here's a breakdown based on the provided text:

Key Takeaway: This 510(k) submission for a dental bonding agent relies on non-clinical performance data and biocompatibility testing to demonstrate substantial equivalence to a predicate device. It does not involve a study for an AI/ML-based device with acceptance criteria related to human-in-the-loop performance, ground truth establishment by experts, or MRMC studies.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All test results met their acceptance criteria and support that the Rainbow 360 is appropriately designed for their intended use." However, it does not explicitly list the quantitative acceptance criteria for each test nor the specific reported performance values. It only states that the tests met the criteria.

Acceptance Criteria (Stated as "met")	Reported Device Performance (Specificity not provided)
Bond Strength (per ISO 29022:2013)	Met acceptance criteria. Implies that the bond strength of Rainbow 360 is comparable to or greater than the predicate device and relevant standards.
Shipping Performance (per ASTM D4169:2016)	Met acceptance criteria. Ensures the device packaging and product integrity are maintained during shipping.
Biocompatibility (per ISO-10993-1:2018, ISO 7405:2018, and sub-parts)	Met acceptance criteria. Confirmed safety relative to cytotoxicity, sensitization, irritation, genotoxicity, systemic toxicity, and local effects after implantation.
Shelf-life Testing (Internal)	Met acceptance criteria. Confirms the stability and effectiveness of the product over its stated shelf life of 2 years.
General non-inferiority/similarity to predicate device	The document concludes that "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." This implies performance is within acceptable limits compared to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of bond strength samples, number of biocompatibility specimens). It generally states that "Kerr conducted design verification performance testing".
Data Provenance: Not explicitly stated regarding country of origin for test data, but it's a manufacturer's internal testing. The tests are purely non-clinical and conducted by the manufacturer, not clinical data from patients. The data would be prospective in the sense that the tests were specifically conducted for this submission.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

Not Applicable. This is a dental bonding agent validated through physical and chemical performance tests, not through expert-reviewed clinical imaging or diagnostic data requiring human ground truth.

4. Adjudication Method for the Test Set

Not Applicable. There is no "ground truth" established by experts or adjudication needed for the non-clinical tests described. The tests are objective measurements (e.g., bond strength in megapascals, chemical composition analysis, biological interaction assessments).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for AI/ML diagnostic tools where human readers interpret medical images. This device is a dental material, and its performance is assessed via non-clinical laboratory testing.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an AI/ML algorithm. Its "performance" is its physical and chemical properties and biological safety.

7. The type of ground truth used

For Bond Strength: The "ground truth" is the empirically measured force required to break the bond, compared against industry standards (ISO 29022).
For Biocompatibility: The "ground truth" is the established biological safety criteria in recognized standards (ISO 10993 series, ISO 7405), and the results are evaluated against these criteria.
For Shipping Performance: The "ground truth" is the ability to withstand simulated shipping conditions as defined by the standard (ASTM D4169).
For Shelf-life: The "ground truth" is the maintenance of performance characteristics over time.

8. The sample size for the training set

Not Applicable. This is a physical product, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. As above, no training set for an AI/ML model is involved.

Summary

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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.

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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

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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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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:

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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.

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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.

DescriptiveInformation	Subject DeviceRainbow 360	Predicate DeviceAdh19 (K192961)	Comparison
PictorialRepresentation	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
DescriptiveInformation	Subject DeviceRainbow 360	Predicate DeviceAdh19 (K192961)	Comparison
Indications for Use	Direct Applications• Light-cured, self-cured and dual-cured composite and compomerrestorations.• Composite/ceramic/metal repairs.• Tooth preparation and rootsurface sealer.• Cavity sealing for amalgamrestorations.• Light-cured or dual-cured corebuild-ups.• Bonding of methacrylate-basedfissure sealants.Indirect Applications• Cementation of veneers• Cementation of porcelain,composite, and metal-basedrestorations• Cementation of endodontic posts• Cavity sealing as a pretreatmentfor indirect restorations.• Prime metal, ceramic, andcomposite substrates /restorations.	Direct Indications• Bonding for all methacrylate-based light-, dual-, and self-cure composite or compomerfilling materials• Root surface desensitization• Bonding of methacrylate-basedfissure sealants• Protective varnish for glassionomer fillings• Repair of composite andcompomer fillings• Sealing of cavities prior toplacement of amalgamrestorationsIndirect Indications:• Cementation of indirectrestorations in combinationwith Suglue 3 and other resincements (follow applicableInstructions for Use)• Bonding for all methacrylate-based light-, self-, and dual-cure core build-up materialsand cements• Cementation of veneers whencombined with RelyX VeneerCement• Intraoral repair of compositerestorations, porcelain fused tometal, and all-ceramicrestorations without extraprimer• Sealing of cavities andpreparation of tooth stumpsprior to temporary cementationof indirect restorations	Same Indication forUse as Predicate andexpressed through asimilar choice ofwords.
Intended Use	Rainbow 360 is a universal bondingagent intended to bondmethacrylate-based restorativematerials, cements and sealants todentin, enamel, and various indirectrestorative substrates. It can be usedin a self-etch mode, selective etchmode or in a total-etch mode forboth direct and indirect dentalrestorative procedures.	A material primarily intended to beused as a bonding-promotingsubstance between tooth substanceand dental restorations. It may alsobe used as a dentin sealant and asa bonding agent for repair ofrestorations.Intended to bond methacrylate-based restorative, cement andsealant materials to dentin, enamel,glass ionomer and various indirectrestorative substrates (metals,glass ceramics, alumina, andzirconia). The primary use will bewith light cured materials and it willhave the capability to also bond	Same intended use asPredicate andexpressed through asimilar choice ofwords.
		self- or dual-cure composite andcement materials.
DescriptiveInformation	Subject DeviceRainbow 360	Predicate DeviceAdh19 (K192961)	Comparison
Composition	Phosphoric acid modifiedmethacrylate, monofunctionalmethacrylate, difunctionalmethacrylate, 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-componentdental adhesive	One-component dental adhesive	One-component dental adhesive	Same as Predicate
Configurations	5ml bottle for multiple uses0.18 ml Unidose for single use	5ml Vial0.11 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 totaletch	Self-etch, selective etch, and totaletch	Same as Predicate
Substrate'scompatibility	Dentin, enamel, composite, metal,porcelain/ceramic substrates	Dentin, enamel, resin, compomer,metal, ceramic substrates	Same as Predicate
Cementscompatibility	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
Biocompatibilitytesting	Biocompatible per ISO 10993-1 andISO 7405	Biocompatible per ISO 10993-1 andISO 7405	Same as Predicate

Table 5-1 Device Comparison Table:

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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.

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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.

Regulation Number and Section

§ 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.