(169 days)
No
The summary describes a system for manufacturing dental splints using a scanner, resin, 3D printer, and curing unit. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is used to create "removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints".
No
The device is described as a light-cured resin used to create removable structures like bite guards/splints and occlusal night guards/splints using additive manufacturing. It is a material for manufacturing a medical device, not a diagnostic tool that identifies or determines a medical condition.
No
The device description explicitly states it is a "combination of a scanner, resin, 3D printer, and curing unit," which are all hardware components. The software is part of a system that includes hardware.
Based on the provided information, the Whip Mix VeriSplint is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create removable structures for therapeutic restorations like bite guards and occlusal night guards. This is a direct application to the patient for therapeutic purposes, not for diagnosing a condition.
- Device Description: The device is a resin used in a system to manufacture a physical appliance (splint/bite guard). It's a material for creating a medical device, not a test or reagent used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures. The Whip Mix VeriSplint does not fit this definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MOC, EBI
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.
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
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: > 100 MPa (Requirement ≥ 50 MPa)
Flexural Modulus: > 2500 MPa (Requirement ≥ 1500 MPa)
Water solubility:
N/A
0
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:
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: (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
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, |
| 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 | 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.