(154 days)
No
The 510(k) summary describes a dental resin and the associated manufacturing process, which involves CAD/CAM and 3D printing. There is no mention of AI or ML being used in the design, manufacturing, or analysis of the device or the resulting dental appliance. The process relies on digital files and clinician judgment.
No.
The device is a resin used to fabricate dentures, which are prosthetic devices, not therapeutic ones. Its purpose is to replace missing teeth and restore oral function, not to treat a disease or condition.
No
This device is a material (resin) used for the fabrication and repair of dentures and baseplates. It is a manufacturing component, not a diagnostic tool that identifies or assesses a medical condition.
No
The device is a light-curable polymerizable resin, which is a physical material used in the fabrication of dentures. It is not software.
Based on the provided information, the SprintRay High Impact Denture Base resin 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 medical device intended for direct use in the patient's oral cavity, not for testing samples taken from the body.
- Device Description: The description clearly outlines its use in a computer-aided design and manufacturing system to create a dental appliance for a patient. It's a material used to build a physical prosthetic.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or determine the state of a disease or condition based on in vitro examination of specimens derived from the human body.
IVD devices are specifically designed for testing biological samples (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device is a material used to create a physical prosthetic that is placed in the body.
N/A
Intended Use / Indications for Use
The SprintRay High Impact 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.
Product codes
EBI
Device Description
Fabrication of dental prosthetics with High Impact 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.
The High Impact 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.
High Impact Denture Base Resin is intended exclusively for professional dental work. SprintRay High Impact Denture Base Resin is offered in following shades/colors:
- Light Pink .
- Original Pink ●
- . Light Meharry
- Original Meharry .
- . Dark Meharry
High Impact 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
Clinicians in 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 High Impact 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
High Impact Denture Base is considered tissue contacting for a period longer than 30 days (a removable prosthesis).
Bench Testing
High Impact 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, High Impact Denture Base functioned as intended and the outcomes were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dentca Denture Base II (K162044)
Reference Device(s)
Dentca Denture Base (K143033)
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
§ 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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November 10, 2022
SprintRay Inc. Sara Moghtadernejad Regulatory Affairs Manager 2705 Media Center Drive, Suite 100A Los Angeles, California 90065
Re: K221678
Trade/Device Name: SprintRay High Impact Denture Base Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: October 14, 2022 Received: October 17, 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.
1
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.
Michael E. Adjodha -S
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 Ouality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
Device Name
SprintRay High Impact Denture Base
Indications for Use (Describe)
The SprintRay High Impact 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
K221678
SprintRay High Impact Denture Base
Submitter: SprintRay Inc. 2705 Media Center Drive, Suite 100A Los Angeles, CA 90065
Phone: +1 (800) 914-8004
Contact Person: Sara Moghtadernejad
Date Prepared: Nov 1, 2022
Name of Device: SprintRay High Impact Denture Base
Common or Usual Name: Denture Base, Prescription
Classification Name: Denture relining, repairing, or rebasing resin
Regulatory Class: Class II
Requlation Number: 21 CFR 872.3760
Product Code: EBI
Primary Predicate Device: Dentca Denture Base II (K162044)
Reference Devices: Dentca Denture Base (K143033)
Device Description
Fabrication of dental prosthetics with High Impact 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.
The High Impact 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.
High Impact Denture Base Resin is intended exclusively for professional dental work. SprintRay High Impact Denture Base Resin is offered in following shades/colors:
- Light Pink .
- Original Pink ●
- . Light Meharry
4
- Original Meharry .
- . Dark Meharry
High Impact 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
The SprintRay High Impact 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.
Summary of Technological Characteristics
Light curing of a 3D printed acrylate resin is the technological principle for both the subject and predicate devices. The High Impact Denture Base 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 coniunction 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 High Impact 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
High Impact Denture Base is considered tissue contacting for a period longer than 30 days (a removable prosthesis).
Bench Testing
High Impact 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, High Impact Denture Base functioned as intended and the outcomes were as expected.
6
Equivalence to Marketed Devices
| Feature | Dentca Denture Base II
Predicate Device | Dentca Denture Base
Reference Device | SprintRay High Impact
Denture Base | Conclusion |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | EBI | EBI | EBI | Similar |
| Regulation | 21 CFR 872.3760 | 21 CFR 872.3760 | 21 CFR 872.3760 | Similar |
| Intended Use &
Indications for Use | Dentca Denture Base II
is a light-cured resin
indicated for fabrication
and repair of full and
partial removable
dentures and
baseplates. The
material is an
alternative to
traditional heat-cured
and auto polymerizing
resins.
Fabrication of dental
prosthetics with Dentca
Denture Base II requires
a computer-aided
design and
manufacturing
(CAD/CAM) system that
includes the following
components not part of
the device: oral casting
impression, digital
denture base file
created in an optical
impression system,
stereolithographic
additive printer, and
curing light equipment. | Dentca Denture Base is
a light-cured resin
indicated for fabrication
and repair of full and
partial removable
dentures and
baseplates. The material
is an alternative to
traditional heat-cured
and auto polymerizing
resins.
Fabrication of dental
prosthetics with Dentca
Denture Base requires a
computer-aided design
and manufacturing
(CAD/CAM) system that
includes the following
components not part of
the device: oral casting
impression, digital
denture base file
created in an optical
impression system,
stereolithographic
additive printer, and
curing light equipment. | The SprintRay High
Impact 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. | Similar |
| User Population | Clinicians in dental offices | Clinicians in dental offices | Clinicians in dental offices | Similar |
| Chemical
Description | Methacrylate-based resin | Methacrylate-based resin | Methacrylate-based resin | Similar |
| Material Type | Light-curable Resin | Light-curable Resin | Light-curable Resin | Similar |
| Curing Method | UV Light | UV Light | UV Light | Similar |
| Product State | Liquid | Liquid | Liquid | Similar |
| Manufacturing
Technology Type | Additive | Additive | Additive | Similar |
| Volume provided | 1kg bottle | 1kg bottle | 1kg bottle | Similar |
| Shelf life | >1.5 years | >1.5 years | 1.5 years | Similar |
| Standards | ISO 20795-01 | ISO 20795-01 | ISO 20795-01 | Similar |
| | | | | |
| Physical and
Mechanical
Properties | Flexural Strength and
Modulus | Flexural Strength and
Modulus | Flexural Strength and
Modulus | Similar |
| | Water Sorption and
Solubility | Water Sorption and
Solubility | Water Sorption and
Solubility | |
| | Stability | Stability | Stability | |
| | Residual Methyl
Methacrylate Monomers | Residual Methyl
Methacrylate Monomers | Residual Methyl
Methacrylate Monomers | |
| | Homogeneity | Homogeneity | Homogeneity | |
| | Surface Characteristics | Surface Characteristics | Surface Characteristics | |
| | Shape Capability,
Translucency, and
Polishability | Shape Capability,
Translucency, and
Polishability | Shape Capability,
Translucency, and
Polishability | |
| | Freedom from Porosity | Freedom from Porosity | Freedom from Porosity | |
| | Color Stability | Color Stability | Color Stability | |
| Biocompatibility | Tested to ISO 7405, ISO-
10993-1 | Tested to ISO 7405, ISO-
10993-1 | Tested to ISO 7405, ISO-
10993-1 | Similar |
| | Genotoxicity (Part 3) | Genotoxicity (Part 3) | Genotoxicity (Part 3) | |
| | Cytotoxicity (Part 5) | Cytotoxicity (Part 5) | Cytotoxicity (Part 5) | |
| | Acute Systematic Toxicity
(Part 11) | Acute Systematic Toxicity
(Part 11) | Acute Systematic Toxicity
(Part 11) | |
| | Sensitization (Part 10) | Sensitization (Part 10) | Sensitization (Part 10) | |
| | Irritation (Part 10) | Irritation (Part 10) | Irritation (Part 10) | |
| Additive
Manufacturing | Testing, according to
FDA's guidance
Technical
Considerations for
Additive Manufactured
Medical Devices, was
performed and results
were provided in the
510(k). These tests
included evaluation of
all relevant properties
of the printed resin
using the permitted
machines. Further,
tests based on
considerations of the
orientation during
manufacturing were | Testing, according to
FDA's guidance
Technical
Considerations for
Additive Manufactured
Medical Devices, was
performed and results
were provided in the
510(k). These tests
included evaluation of
all relevant properties
of the printed resin
using the permitted
machines. Further,
tests based on
considerations of the
orientation during
manufacturing were | Testing, according to
FDA's guidance
Technical
Considerations for
Additive Manufactured
Medical Devices, was
performed and results
were provided in the
510(k). These tests
included evaluation of
all relevant properties
of the printed resin
using the permitted
machines. Further,
tests based on
considerations of the
orientation during
manufacturing were | Similar |
| Printer Device | SprintRay Pro 95 | SprintRay Pro 95 | SprintRay Pro 95 | Similar |
| Post-Cure Device | SprintRay ProCure 2 | SprintRay ProCure 2 | SprintRay ProCure 2 | Similar |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Similar |
7
8
Conclusions
The High Impact Denture Base resin is as safe and effective as its predicate and reference devices. The High Impact Denture Base has the same intended use and indication, and similar technological characteristics, and principles of operation as its predicate and reference devices. The minor technological differences between the High Impact Denture Base and its predicate and reference devices raise no new issues of safety or effectiveness. Performance data demonstrate that the High Impact Denture Base is as safe and effective as the predicate and reference devices. Thus, the High Impact Denture Base is substantially equivalent.