Whip Mix VeriSplint is a light-cured resin. It is a polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.

Device Description

The VeriSplint ®OS system is a combination of a scanner, resin, 3D printer, and curing unit. The system components work together to manufacture a splint/bite guard. The additive manufactured appliance is part of a photo-cured product family that is a combination of methacrylate resins. In general, the products in this family are composed of a 3-component methacrylic system, polymerized via photo initiators in a 3D printer setting. The material is an alternative to traditional heat cured and auto polymerizing resins.

AI/ML Overview

The provided text describes the Whip Mix VeriSplint device and its performance testing to demonstrate substantial equivalence to predicate devices, primarily for its physical and chemical properties as a dental material. It does not describe a study involving human-in-the-loop performance, expert ground truth establishment for a test set, or MRMC studies, as would be common for AI/ML-based medical devices.

Therefore, many of the requested elements for the acceptance criteria and study proving device performance (specifically those related to AI/ML and human reading studies) are not applicable to the information provided in this document.

Here's the information that can be extracted from the provided text, focusing on the material characteristics and the regulatory review process for VeriSplint:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on the requirements of ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic base polymers, and comparison to predicate devices.

Requirement	Acceptance Criteria (from ISO 20795-2:2013 or inferred from predicate)	Reported VeriSplint Performance	Primary Predicate Performance (K150432)	Reference Predicate Performance (K162572)
Flexural Strength	≥ 50 MPa	> 100 MPa	90 MPa	Not provided
Flexural Modulus	≥ 1500 MPa	> 2500 MPa	Not provided	Not provided
Water Solubility	≤ 5µg/mm³	< 1 µg/mm³	0.0000 mg/mm³	Not provided
Water Sorption	≤ 32µg/mm³	29 µg/mm³	0.023 mg/mm³	Not provided
Residual Monomer Content	≤ 5%	≤ 0.10 %	1.4%	Not provided
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Biocompatible

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for mechanical or chemical testing. It only states that tests were performed and results are reported. Data provenance is implied to be from laboratory testing conducted by Whip Mix Corporation. (e.g., this is likely physical material testing, not clinical data or image data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a material, not an AI/ML diagnostic or image analysis device that would require expert ground truth for a test set in the conventional sense. The "ground truth" here is established via adherence to international standards for dental materials (ISO 20795-2:2013).

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert readings/interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done, as this is a dental material, not a diagnostic imaging device.

6. If a standalone (i.g., algorithm-only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. The performance described relates to the physical and chemical properties of the resin itself.

7. The type of ground truth used

The ground truth for the performance claims (Flexural Strength, Flexural Modulus, Water Solubility, Water Sorption, Residual monomer content, Biocompatibility) is established by the international standard ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic base polymers. Biocompatibility would also rely on other relevant ISO standards (e.g., ISO 10993 series).

8. The sample size for the training set

Not applicable. This is a material, not a machine learning model; therefore, there is no "training set" in the context of AI/ML.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

July 10, 2019

Whip Mix Corporation John Waters Quality Assurance Manager 361 Farmington Avenue Louisville, Kentucky 40217

Re: K190107

Trade/Device Name: VeriSplint Regulatory Class: Unclassified Product Code: MOC, EBI Dated: April 09, 2019 Received: April 11, 2019

Dear John Waters:

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 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 Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Whip Mix. The logo is in a blue oval with the words "Whip Mix" in white letters. Below the logo are the words "more reasons. one source" in a smaller font and a purple color. The background is white.

Whip Mix Corporation ● 361 Farmington Avenue ● P.O. Box 17183 ● Louisville, Kentucky 40217 USA ● Phone: (502)637-1451 ● Fax(502)634-4512 ● www.whipmix.com

4. Indications for Use

Indications for Use

K190107 510(k) Number (if known):

Indications for Use:

Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ × AND/OR (21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for Whip Mix. The logo is in a blue oval with the words "Whip Mix" in white letters. Below the logo is the tagline "more reasons. one source" in a smaller, red font. The logo is simple and clean, and the tagline is memorable.

Whip Mix Corporation · 361 Farmington Avenue · P.O. Box 17183 · Louisville, Kentucky 40217 USA · Phone: (502)637-1451 ● Fax(502)634-4512 ● www.whipmix.com

5. 510K Summary K190107

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92

Date Prepared: April 9, 2019

5.1 APPLICANT

Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217

PHONE: 502-634-5357 FAX: 502-634-7167 EMAIL: jwaters@whipmix.com

5.2 SUBMITTER and CONTACT

John P. Waters Quality Assurance Manager Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217

PHONE: 502-634-5357 FAX: 502-634-4512 EMAIL: jwaters@whipmix.com DATE: Jun 26, 2019

5.3 DEVICE NAME

VeriSplint

5.4 COMMON OR USUAL NAME AND CLASSIFICATION

Mouthguard, Prescription Regulation Number: Un-classified Product Code: MQC Reference Product Code: EBI Classification: Dental

5.5 PREDICATE DEVICE INFORMATION

Whip Mix claims K150432, Idodentine Dental Polymer Blank as the primary predicate. K162572, Nextdent Denture/EDenture is our reference predicate.

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Image /page/4/Picture/0 description: The image is a logo for "Whip Mix". The logo is in a blue oval shape with the words "Whip Mix" in white letters. Below the logo is the phrase "more reasons. one source" in a smaller font and a purple color. The background is white.

Whip Mix Corporation · 361 Farmington Avenue · P.O. Box 17183 · Louisville, Kentucky 40217 USA · Phone: (502) 637-1451 ● Fax (502) 634-4512 ● www.whipmix.com

5.6 DEVICE DESCRIPTION

5.7 INDICATIONS FOR USE

Requirement	Whip Mix new device	Primary Predicate	Reference Predicate
Class	Un-classified	II	II
510K number	K190107	K150432	K162572
Device Name	VeriSplint	Idodentine Disc, Idodentine Block	Nextdent Denture, E-Denture
Device Classification Name	Mouthguard, Prescription	Crown and Bridge, Temporary, Resin	Resin, Denture, Relining,Repairing, Rebasing
Classification Code	MQC, EBI	EBG, EBI, MQC	EBI
Ingredient	Light-cured Resin	Hot cured PMMA	Light-cured Resin
Manufacturing Technology	Additive	Heat cured	Additive
Flexural Strength≥ 50 MPa	> 100 MPa	90 MPa	Not provided
Flexural Modulus≥ MPa 1500	> 2500 MPa	Not provided	Not provided
Regards to sterility	Non Sterile	Non Sterile	Not provided
Water solubility≤ 5µg/mm³	< 1 µg/mm³	0.0000 mg/mm³	Not provided
Water Sorption≤ 32µg/mm³	29 µg/mm³	0.023 mg/mm³	Not provided
Indications for Use	Whip Mix VeriSplint is a light-cured resin. It is an orthodonticbase polymer used to createremovable structures fortherapeutic restorations like biteguards/splints and occlusal nightguards/splints using the AdditiveManufacturing process. The resinin combination with a scanner,printer, and curing unit make upthe system.	Acrylic polymer blank particularlysuitable for making removable ortemporary dental structures suchas crowns and bridges usingmilling technology usingCAD/CAM.Indications-Temporary anterior andposterior crowns- Temporary anterior andposterior bridges with up to twoadjacent pontics- Implant supported temporary	NextDent Denture / E-Denture isa light-cured resin indicated forthe fabrication of denture basesfabricated in dental laboratories,including full and partialremovable dentures.

5.8 SUBSTANTIAL EQUIVALENCE WITH PREDICATE DEVICES

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Image /page/5/Picture/0 description: The image shows the logo for Whip Mix. The logo is in a blue oval shape with the words "Whip Mix" in white letters. Below the logo are the words "more reasons. one source" in a smaller font. The background is white.

Whip Mix Corporation · 361 Farmington Avenue · P.O. Box 17183 · Louisville, Kentucky 40217 USA · Phone: (502) 637-1451 · Fax (502) 634-4512 · www.whipmix.com

Requirement	Whip Mix new device	Primary Predicate	Reference Predicate
		recommended usage period: 12months- Removable structures fordentures (dental bases)- Removable structures fortherapeutic restorations (bitesplints or occlusal splints)
Biocompatibility	Biocompatible	Biocompatible	Biocompatible
Residual monomer content$ \le $ 5%	$\le$ 0.10 %	1.4%	Not provided

5.9 PERFORMANCE TESTING

The predicate performed tests for Flexural Strength, Flexural Modulus, Water Sorption, Biocompatibility, and Residual monomer content. Whip Mix performed these tests as well and all met the requirements of ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic base polymers.

5.10 BIOCOMPATIBILITY

Test results confirm Verisplint meets all the requirements for biocompatibility.

5.11 PREDICATE DIFFERENCE DISCUSSION

Whip Mix performed testing as that of the predicate. Flexural Modulus, Water Solubility, Water Sorbtion, residual monomer, and all results were similar to that of the predicate.

Our new device is similar to our main predicate K150432. They both have the product code MQC. Both IFU's state they can be used for removable structures for therapeutic restorations (bite splints or occlusal splints). Both meet the requirements of ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic base polymers, and are biocompatible.

Our new device is also similar to our reference predicate K162572. Both have product code EBI. Both are light-cured resins used in the additive manufacturing process and use a resin, scanner, printer, and curing unit in the additive manufacturing process. Both comply with ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic base polymers, contact the mucosal membrane for > 30 days, and both are biocompatible.

5.12 CONCLUSION

The VeriSplint system is very similar to both predicates and demonstrate substantial equivalence to Union Dental K150432, and Vertex-Dental K162572. An analysis for our device compared to the predicates show Verisplint and the Idodentine Disc meet the requirements of ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic base polymers. All three devices share product code, meet or exceed the minimum strength requirements, and all three are biocompatible. Any differences between Whip Mix new device are minimal and present no new risks.

Regulation Number and Section

N/A