(163 days)
Not Found
No
The summary describes a dental resin material and the associated manufacturing process (CAD/CAM, 3D printing). There is no mention of AI or ML being used in the design, manufacturing, or analysis of the device or the resulting prosthetic. The process relies on a digital file created from an optical impression and clinician judgment.
No
The device is a material (resin) used to fabricate and repair dentures, which are restorative devices, not therapeutic devices. Therapeutic devices are typically used for treating or alleviating a medical condition.
No
This device is a light-curable polymerizable resin used for the fabrication and repair of full and partial removable dentures and baseplates. It is a material used in the manufacturing process of a medical device, not a device that diagnoses a condition.
No
The device is a physical resin material used for fabricating dentures, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fabrication and repair, of full and partial removable dentures and baseplates." This is a manufacturing process for a medical device (a denture), not a diagnostic test performed on a biological sample to provide information about a patient's health status.
- Device Description: The device is a "curable dental acrylate resin" used in conjunction with a 3D printer to create a dental appliance. It's a material used in the manufacturing process, not a test kit or instrument for analyzing biological samples.
- Lack of Diagnostic Activity: There is no mention of the device being used to detect, measure, or analyze any biological markers, substances, or characteristics in a sample (like blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases.
- Bench Testing: The bench testing focuses on the physical and chemical properties of the resin (flexural strength, water sorption, etc.) and its biocompatibility, which are relevant for a material used to create a medical device, not for a diagnostic test.
In summary, the SprintRay Denture Base resin is a material used in the manufacturing of a dental prosthetic, which is a medical device. It does not perform any diagnostic function.
N/A
Intended Use / Indications for Use
SprintRay Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.
Fabrication of dental prosthetics with SprintRay Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.
Product codes
EBI
Device Description
SprintRay Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.
SprintRay Denture Base resin is intended exclusively for professional dental work. SprintRay Denture Base resin is offered in following shades/colors:
- Light Pink
- Original Pink
- Light Meharry
- Original Meharry
- Extra Light Pink
- Medium Pink
- Dark Pink
- Dark Meharry
- Deep Dark Meharry
SprintRay Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical impression system
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional dental work / dental offices
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)
Biocompatibility Testing
The biocompatibility evaluation for SprintRay Denture Base was conducted in accordance with the FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1 and ISO 7405, as recognized by FDA. The battery of testing included the following tests:
- Genotoxicity
- Cytotoxicity
- Acute Systematic Toxicity
- Sensitization
- Irritation
SprintRay Denture Base is considered tissue contacting for a period longer than 30 days (a removable prosthesis).
Bench Testing
SprintRay Denture Base was tested for conformity with the industry consensus standard ISO 20795-1. The battery of testing included the following tests:
- Flexural Strength and Modulus
- Water Sorption and Solubility
- Stability
- Residual Methyl Methacrylate Monomers
- Homogeneity
- Surface Characteristics
- Shape Capability, Translucency, and Polishability
- Freedom from Porosity
- Color Stability
In all instances, SprintRay Denture Base functioned as intended and the outcomes were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
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September 14, 2022
SprintRay Inc Sara Moghtadernejad Regulatory Affairs Manager 2705 Media Center Drive, Suite 100A Los Angeles, California 90065
Re: K220979
Trade/Device Name: SprintRay Denture Base Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: August 16, 2022 Received: August 16, 2022
Dear Sara Moghtadernejad:
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.
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
1
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,
For 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
2
510(k) Number (if known)
Device Name
SprintRay Denture Base
Indications for Use (Describe)
SprintRay Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.
Fabrication of dental prosthetics with SprintRay Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY-K220979
SprintRay Denture Base
Submitter: SprintRay Inc. 2705 Media Center Drive, Suite 100A Los Angeles, CA 90065
Phone:
Contact Person: Sara Moghtadernejad
Date Prepared: March 31, 2022
Name of Device: SprintRay Denture Base
Common or Usual Name: Denture Base, Prescription
Classification Name: Denture Base, Prescription
Regulatory Class: Class II
Regulation Number: 21 CFR 872.3760
Product Code: EBI
Predicate Devices
Dentca Denture Base (K143033)
Device Description
SprintRay Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.
SprintRay Denture Base resin is intended exclusively for professional dental work. SprintRay Denture Base resin is offered in following shades/colors:
- Light Pink ●
- Original Pink ●
- Light Meharry ●
- Original Meharry ●
- Extra Light Pink ●
- Medium Pink ●
- Dark Pink ●
4
- Dark Meharry ●
- . Deep Dark Meharry
SprintRay Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
Intended Use / Indications for Use
SprintRay Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.
Fabrication of dental prosthetics with SprintRay Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.
Summary of Technological Characteristics
Light-Denture Based curing of a 3D printed acrylate resin is the technological principle for both the subject and predicate devices. SprintRay Denture Base resin is poured into a 3D printer, which relies on scanned images of the patient's oral cavity to produce a dental appliance. At a high level, the subject and predicate devices are based on the following same technological elements:
- Are a pourable acrylate resin
- · Are used in conjunction with 3D printers, which rely on common 3D images to define the fabricated dental appliance
- · Are cured prior to final trimming and cleaning
- · Are used for the fabrication of orthodontic and dental appliances
The following technological differences exist between the subject and predicate devices:
- · Differences in acrylate resin material
5
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for SprintRay Denture Base was conducted in accordance with the FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1 and ISO 7405, as recognized by FDA. The battery of testing included the following tests:
- Genotoxicity
- Cytotoxicity ●
- Acute Systematic Toxicity ●
- Sensitization ●
- Irritation ●
SprintRay Denture Base is considered tissue contacting for a period longer than 30 days (a removable prosthesis).
Bench Testing
SprintRav Denture Base was tested for conformity with the industry consensus standard ISO 20795-1. The battery of testing included the following tests:
- Flexural Strength and Modulus ●
- Water Sorption and Solubility ●
- Stability ●
- Residual Methyl Methacrylate Monomers ●
- Homogeneity ●
- Surface Characteristics
- Shape Capability, Translucency, and Polishability ●
- Freedom from Porosity ●
- Color Stability ●
In all instances, SprintRay Denture Base functioned as intended and the outcomes were as expected.
Conclusions
SprintRay Denture Base resin is as safe and effective as its predicate device. SprintRay Denture Base has the same intended use and indication, and similar technological characteristics, and principles of operation as its predicate device. The minor technological differences between SprintRay Denture Base and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that SprintRay Denture Base is as safe and effective as the predicate device. Thus, SprintRay Denture Base is substantially equivalent.