(143 days)
Not Found
No
The summary describes a dental resin material and the process for fabricating dental prosthetics using CAD/CAM technology. There is no mention of AI or ML being used in the design, fabrication, or analysis process. The "computer-aided design" refers to standard CAD software, not AI-driven design.
Yes
The device is a material used for the fabrication of dental prosthetics, which are therapeutic devices designed to restore or enhance oral function and aesthetics.
No
This device is a material (resin) for fabricating dental prosthetics, not for diagnosing medical conditions. It is used in the manufacturing process based on a clinician's judgment, not for detecting, monitoring, or predicting diseases.
No
The device is a curable dental acrylate resin, which is a physical material used in the fabrication of dental prosthetics. While it is used in conjunction with digital data and manufacturing processes, the device itself is a tangible substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The SprintRay OnX Tough resin is a material used to fabricate dental prosthetics. It is a component in a manufacturing process that creates a physical device (a denture or prosthetic) that is placed in the patient's body.
- Lack of Biological Sample Testing: The description clearly states that the resin is used in conjunction with a 3D scanned image of the patient's teeth and a 3D printer. There is no mention of testing biological samples from the patient.
- Intended Use: The intended use is for the fabrication of dental prosthetics, not for diagnosing or monitoring a medical condition through the analysis of biological samples.
The device is a medical device, specifically a dental material used in the fabrication of custom-made dental prosthetics. It falls under the category of devices used to restore or replace missing teeth or oral structures.
N/A
Intended Use / Indications for Use
SprintRay OnX Tough is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture.
Product codes (comma separated list FDA assigned to the subject device)
EBI, PZY
Device Description
OnX Tough resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need.
Fabrication of dental prosthetics with OnX Tough resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment.
The material is an alternative to traditional dental prostheses material. OnX Tough resin is intended exclusively for professional dental work.
OnX Tough resin is designed to meet appropriate ISO standards for flexibility and sorption, 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
Not Found
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 OnX Tough 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 Genotoxicity, Cytotoxicity, Acute Systematic Toxicity, Sensitization, and Irritation. OnX Tough is considered tissue contacting for a period longer than 30 days (a removable prosthesis). The device Passed these tests.
Bench Testing: OnX Tough was tested for conformity with the industry consensus standard ISO 20795-1. The battery of testing included Flexural Strength and Modulus, Water Sorption and Solubility, Stability, Residual Methyl Methacrylate Monomers, Homogeneity, Surface Characteristics, Shape Capability, Translucency, Polishability, and Freedom from Porosity, Color Stability. Key results include:
- Flexural Strength (>=65 MPa): 71.03 +/- 1.45 MPa
- Flexural Modulus (>=2000 MPa): 2271 +/- 118 MPa
- Sorption (=1.9 MPa*m1/2: 3.176 +/- 0.209
- Total fracture work, >=900 J/m²: 945 +/- 88
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 also performed. In all instances, OnX Tough functioned as intended and the outcomes were as expected.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 14, 2023
SprintRay Inc. Sara Moghtadernejad Regulatory Affairs 2705 Media Center Drive, Suite 100A Los Angeles, California 90065
Re: K230445
Trade/Device Name: OnX Tough Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, PZY Dated: May 18, 2023 Received: May 19, 2023
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
1
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 (OS) 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,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M. ChE., 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
2
510(k) Number (if known)
Device Name
OnX Tough
Indications for Use (Describe)
SprintRay OnX Tough is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture.
| 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 OnX Tough K230445
Submitter: SprintRay Inc. 2705 Media Center Drive, Suite 100A Los Angeles. CA 90065
Phone: (800) 914-8004
Contact Person: Sara Moghtadernejad
Date Prepared: July 12, 2023
| Name of Device: | OnX Tough | ||
|---|---|---|---|
| Common or Usual Name | Denture, Prescription | ||
| Regulation Number and | |||
| Names: | 21 CFR 872.3760, | ||
| Denture Relining, | |||
| Repairing, or Rebasing | |||
| Resin | 21 CFR 872.3590, | ||
| Additively Manufactured, | |||
| Preformed, Resin | |||
| Denture Tooth | |||
| Product Codes | EBI | PZY | |
| Device Class | II | II | |
| 510(k)-Exempt | |||
| Primary Predicate | K221678, SprintRay High Impact Denture Base, | ||
| (EBI product code) | |||
| Secondary Predicate | K151142, IvoBase CAD for Zenotec, | ||
| (EBI product code) |
Device Description
OnX Tough resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need.
Fabrication of dental prosthetics with OnX Tough resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment.
The material is an alternative to traditional dental prostheses material. OnX Tough resin is intended exclusively for professional dental work.
OnX Tough resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile,
4
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 OnX Tough is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture.
The intended use of fabrication of monolithic full and partial removable dentures is the same as the primary predicate device (K221678) (product code EBI). The fabrication of hybrid denture prosthetics, implant-supported denture prosthetics is the same as the secondary predicate device (K151142) (product code EBI). The fabrication of preformed denture teeth to be used in a denture is Class II, but 510(k)-exempt (product code PZY), therefore no predicate is necessary.
The intended use, technological characteristics, and critical specifications, of OnX Tough are similar to both predicate devices.
Summary of Technological Characteristics
OnX Tough and the primary predicate device (K221678) are both 3D printed denture devices. The liquid resin is polymerized in the 3D printer. which creates the final denture device. The secondary predicate device (K151142) is a prepolymerized denture disk that is milled to the final shape of the impression. Here is a more detailed explanation of the two processes:
OnX Tough and Primary Predicate Device
-
- An impression of the patient's mouth is taken.
-
- The impression is scanned and sent to a 3D printer.
-
- The 3D printer creates a mold of the denture.
-
- The mold is filled with liquid resin.
-
- The resin is polymerized, which creates the final denture device.
Secondary Predicate Device
-
- An impression of the patient's mouth is taken.
-
- The impression is scanned and sent to a computer.
-
- A pre-polymerized denture disk is created on the computer.
-
- The disk is milled to the final shape of the impression.
-
- The milled disk is placed in the patient's mouth.
Both OnX Tough and the primary predicate device are created using 3D printing technology. This technology allows for the creation of custom-fit dentures that are more comfortable and durable than traditional dentures. The secondary predicate device is a less expensive option that is still effective in providing patients with a new set of teeth. The principles of operation are essentially similar; therefore, the OnX Tough is substantially equivalent to its predicate devices.
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The following technological differences exist between the subject and predicate devices:
- Differences in acrylate resin material. ●
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for OnX Tough 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
OnX Tough is considered tissue contacting for a period longer than 30 days (a removable prosthesis).
Bench Testing
OnX Tough 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 ●
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 also performed.
In all instances, OnX Tough functioned as intended and the outcomes were as expected.
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EQUIVALENCE TO MARKETED DEVICES
| | Testing
Standards | High Impact
Denture Base
(Primary
Predicate) | IvoBase CAD
for Zenotec
(Secondary
Predicate) | OnX Tough
(Subject Device) |
|-------------------------------------------|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use &
Indications for
Use | N/A | 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. | IvoBase CAD
for Zenotec,
IvoBase CAD
Bond and
Modelling
Liquid is a
system used:
For the
fabrication of
removable
dentures e.g.:
partial and
complete
denture
prosthetics,
hybrid denture
prosthetics,
combined
denture
prosthetics,
mouthguards,
implant-
supported
denture
prosthetics | SprintRay OnX
Tough is a tooth
shade ceramic-
hybrid resin used
for the fabrication
of hybrid denture
prosthetics,
implant-supported
denture prosthetics,
monolithic full and
partial removable
dentures, and
preformed denture
teeth to be used in
a denture. |
| User Population | N/A | Clinicians in
dental offices | Clinicians in
dental offices | Clinicians in dental
offices |
| Biocompatibility | ISO- 10993-1,
-3, -5, -10
and -11 | Passed | Passed | Passed |
| Composition | N/A | Methacrylate
Monomer/oligo
mer s that
polymerized to
Methymethacyl
ate Based
polymer | Traditional
PMMA
Polymer/mono
mer denture
base material
with
pigmentation
for shade. | Methacrylate
Monomer/oligomers
that polymerized to
Methymethacylate
Based polymer. The
subject device has
similar polymer
family to the
predicates except
for small changes in
pigments. |
| Principles of
operation | N/A | Additive
manufacturing
of the
polymerized
denture to the
final
shape of the
impression. | Polymerized
denture disk
milled to the
final shape of
the
impression. | Additive
manufacturing of
the polymerized
denture to the final
shape of the
impression. |
| Performance
Testing | | Testing
performed
according to
ISO standards | Testing
performed
according to
ISO standards | Testing performed
according to ISO
standards |
| Flexural Strength
(≥65 MPa) | ISO 20795-1 | $74.69 ± 1.55$ MPa | ≥65 MPa | $71.03 ± 1.45$ MPa |
| Flexural Modulus
(≥2000 MPa) | ISO 20795-1 | $2253 ± 78$ MPa | ≥2000 MPa | $2271 ± 118$ MPa |
| Sorption (≤32 µg/mm³) | ISO 20795-2 | $28 ± 1$ µg/mm³ | ≤32 µg/mm³ | $31 ± 1$ µg/mm³ |
| Solubility (≤5 µg/mm³) | ISO 20795-2 | $3.5 ± 0.5$ µg/mm³ | ≤5 µg/mm³ | $4.0 ± 0.5$ µg/mm³ |
| Monomer Methyl
Methacrylate
(≤2.2%) | ISO 20795-1 | Pass | Pass | Pass |
| Kmax ≥1.9
MPa*m1/2 | ISO 20795-1 | $3.328 ± 0.147$ | 2.5 | $3.176 ± 0.209$ |
| Total fracture
work,
≥900 J/m² | ISO 20795-1 | $1232 ± 119$ | 1172 | $945 ± 88$ |
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Conclusions
The OnX Tough resin is as safe and effective as its predicate devices. The OnX Tough has the same intended use and indication, and similar technological characteristics as its predicate devices. The minor technological differences between the OnX Tough and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the OnX Tough is as safe and effective as the predicate devices. Thus, the OnX Tough is substantially equivalent.