(277 days)
No
The summary describes a 3D printable resin and the associated system (scanner, software, printer, curing unit) for fabricating dental appliances. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device, "Whip Mix Dental Resin," is a material used for fabricating dental appliances like splints and mouthguards, which are therapeutic in nature. However, the resin itself is a component material, not a therapeutic device that directly performs a diagnostic or healing function.
No
The device description indicates that Whip Mix Dental Resin is a material used for the fabrication of dental appliances. It does not perform any diagnostic function; rather, it is a component in the manufacturing process of devices like splints and mouthguards.
No
The device description explicitly states it is a light-cured resin provided in a plastic container, which is a physical material, not software. The system includes hardware components like a scanner, 3D printer, and curing unit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the fabrication of orthodontic and dental appliances (splints, mouthguards, etc.). These are devices that are placed in the mouth for therapeutic or protective purposes.
- Device Description: The device is a light-curable resin used in a 3D printing system to create these appliances.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVDs are specifically designed to perform tests on biological samples to gain diagnostic information. This device is a material used to create a medical device that is then used on a patient.
N/A
Intended Use / Indications for Use
Hard Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.
Thermo-adaptive Splint is a 3D print light curable resin for the fabrication of thermo-flexible orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.
Product codes (comma separated list FDA assigned to the subject device)
MQC, KMY
Device Description
Whip Mix Dental Resin is light cured resin that is provided in a plastic container, and it is a proprietary blend of ingredients that make a generative resin. When the system (which includes a scanner, design software, printer software, resin, 3D printer, and curing unit) are used in combination, the result is an additive manufactured orthodontic, thermo-flexible orthodontic, or dental appliances such as mouthguards, splint, nightguards, repositioners and retainers.
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)
1.Flexure properties -Whip Mix Internal Requirements
2.Fracture properties -ISO 20795-2
3.Water Sorption and Solubility -ISO 20795-2 & Whip Mix Internal Requirements
4.Residual Methyl Methacrylate- ISO 20795-2
N/A
The Hard Splint and Thermo-Adaptive Splint are biocompatible, similar to the predicate device, and have equivalent or better mechanical testing performance compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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March 18, 2025
Whip Mix Corporation Meena Muniaswamy Q/A Regulatory Manager 361 Farmington Avenue Louisville, Kentucky 40209
Re: K241729 Trade/Device Name: Hard Splint & Thermo-Adaptive Splint Regulatory Class: Unclassified Product Code: MQC, KMY Dated: June 14, 2024 Received: June 14, 2024
Dear Meena Muniaswamy:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
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For Michael E. Adjodha, M.ChE., RAC, CQIA 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Hard Splint:
Thermo-Adaptive Splint
Indications for Use (Describe)
Hard Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthquards, nightquards, repositioners and retainers.
Thermo-adaptive Splint is a 3D print light curable resin for the fabrication of thermo-flexible orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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| 510(k) #: K241729 | 510(k) Summary | Prepared on: 2025-02-15 | ||
|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | WHIP MIX CORPORATION | |||
| Applicant Address | 361 Farmington Avenue Louisville KY 40209 United States | |||
| Applicant Contact Telephone | 502-634-5342 | |||
| Applicant Contact | Mrs. Meena Muniaswamy | |||
| Applicant Contact Email | mmuniaswamy@whipmix.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Hard Splint; Thermo-Adaptive Splint | |||
| Common Name | Splint | |||
| Classification Name | Un-Classified | |||
| Regulation Number | NA (MQC) and 21 CFR 872.5525 (KMY) | |||
| Product Code(s) | MQC, KMY | |||
| Legally Marketed Predicate Devices | ||||
| 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K183598 | KeyPrint KeySplint Soft | MQC | ||
| K190107 | VeriSplint | MQC | ||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| Whip Mix Dental Resin is light cured resin that is provided in a plastic container, and it is a proprietary blend of ingredients that make a generative resin. When the system (which includes a scanner, design software, printer software, resin, 3D printer, and curing unit) are used in combination, the result is an additive manufactured orthodontic, thermo-flexible orthodontic, or dental appliances such as mouthguards, splint, nightguards, repositioners and retainers. | ||||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | |||
| Hard Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers. | ||||
| Thermo-adaptive Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers. | ||||
| Indications for Use Comparison | 21 CFR 807.92(a)(5) | |||
| Yes, the indication for use is same as Predicate device. | ||||
| Technological Comparison | 21 CFR 807.92(a)(6) | |||
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- Comparison of technological characteristics with the predicate device.
The intended use, critical specifications, and additive manufacturing methods of the Hard Splint are substantially equivalent to the predicate device, KeyPrint Soft. Though the chemical composition of the predicate device differs from Whip Mix's resins, all fall into the same material category and are photocureable resins which are used in additive manufacturing.
Additionally, Whip Mix's resins are technologically similar to the reference device K190107, Whip Mix Verisplint, which uses a photocurable resin, similar design software and scanner, as well as the same type of printer software and 3D printer.
- Substantial Equivalence Conclusion
Based on the similarities in product code, classifications, materials, technical features, and biocompatibility results, the new Whip Mix resins demonstrate substantial equivalence to the predicate device, KeyPrint KeySplint Soft.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
1.Flexure properties -Whip Mix Internal Requirements
2.Fracture properties -ISO 20795-2
3.Water Sorption and Solubility -ISO 20795-2 & Whip Mix Internal Requirements
4.Residual Methyl Methacrylate- ISO 20795-2
N/A
The Hard Splint and Thermo-Adaptive Splint are biocompatible, similar to the predicate device, and have equivalent or better mechanical testing performance compared to the predicate device.