VeriSplint

K190107 · Whip Mix Corporation · MQC · Jul 10, 2019 · DE

Device Facts

• Record ID: K190107
• Device Name: VeriSplint
• Applicant: Whip Mix Corporation
• Product Code: MQC · DE
• Decision Date: Jul 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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 Story

VeriSplint is a light-cured methacrylate resin system for additive manufacturing of dental appliances; includes scanner, 3D printer, and curing unit. Used in dental laboratories by technicians to fabricate bite guards/splints and occlusal night guards. Resin is polymerized via photo-initiators in a 3D printer. Final appliance is a removable therapeutic restoration. Benefits include material properties (flexural strength/modulus) exceeding traditional heat-cured resins and biocompatibility for mucosal contact. Healthcare providers use the finished appliance to manage occlusal conditions.

Clinical Evidence

Bench testing only. Testing performed per ISO 20795-2:2013 (Dentistry – Base Polymers – Part 2: Orthodontic base polymers). Results: Flexural strength > 100 MPa, Flexural modulus > 2500 MPa, Water solubility < 1 µg/mm³, Water sorption 29 µg/mm³, and residual monomer content ≤ 0.10%. Biocompatibility testing confirmed compliance.

Technological Characteristics

Light-cured 3-component methacrylic resin system. Additive manufacturing (3D printing). Non-sterile. Complies with ISO 20795-2:2013. Biocompatible. Mechanical properties: Flexural strength > 100 MPa, Flexural modulus > 2500 MPa.

Indications for Use

Indicated for patients requiring removable therapeutic dental restorations, specifically bite guards/splints and occlusal night guards/splints.

Predicate Devices

• Idodentine Dental Polymer Blank (K150432)

Reference Devices

• Nextdent Denture/EDenture (K162572)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] ● Fax[phone] ● www.whipmix.com

# 4. Indications for Use

# Indications for Use

K190107 510(k) Number (if known):

Indications for Use:

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.

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: [phone] ● Fax[phone] ● 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: [phone] FAX: [phone] EMAIL: [e-mail]

## 5.2 SUBMITTER and CONTACT

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

PHONE: [phone] FAX: [phone] EMAIL: [e-mail] 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: [phone] ● Fax [phone] ● www.whipmix.com

# 5.6 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.

### 5.7 INDICATIONS FOR USE

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.

| 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,<br>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<br>≥ 50 MPa | > 100 MPa | 90 MPa | Not provided |
| Flexural Modulus<br>≥ MPa 1500 | > 2500 MPa | Not provided | Not provided |
| Regards to sterility | Non Sterile | Non Sterile | Not provided |
| Water solubility<br>≤ 5µg/mm³ | < 1 µg/mm³ | 0.0000 mg/mm³ | Not provided |
| Water Sorption<br>≤ 32µg/mm³ | 29 µg/mm³ | 0.023 mg/mm³ | Not provided |
| Indications for Use | Whip Mix VeriSplint is a light-<br>cured resin. It is an orthodontic<br>base polymer used to create<br>removable structures for<br>therapeutic restorations like bite<br>guards/splints and occlusal night<br>guards/splints using the Additive<br>Manufacturing process. The resin<br>in combination with a scanner,<br>printer, and curing unit make up<br>the system. | Acrylic polymer blank particularly<br>suitable for making removable or<br>temporary dental structures such<br>as crowns and bridges using<br>milling technology using<br>CAD/CAM.<br>Indications<br>-Temporary anterior and<br>posterior crowns<br>- Temporary anterior and<br>posterior bridges with up to two<br>adjacent pontics<br>- Implant supported temporary | NextDent Denture / E-Denture is<br>a light-cured resin indicated for<br>the fabrication of denture bases<br>fabricated in dental laboratories,<br>including full and partial<br>removable 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: [phone] · Fax [phone] · www.whipmix.com

| Requirement | Whip Mix new device | Primary Predicate | Reference Predicate |
|------------------------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| | | recommended usage period: 12<br>months<br>- Removable structures for<br>dentures (dental bases)<br>- Removable structures for<br>therapeutic restorations (bite<br>splints or occlusal splints) | |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Residual monomer content<br>$ \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.