(63 days)
No
The device description and performance studies focus on the material properties and clinical performance of a dental restorative system, with no mention of AI or ML.
No
The device is a dental restorative system used for bonding and filling cavities, not for treating diseases or conditions.
No
The device is described as a "dental restorative system" used for "Dentin and enamel bonding" and filling "cavities". This indicates a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly outlines physical components (capsule, primer, bottle, brush applicator) and mentions bench testing related to material properties and performance, not software. The "Software verification and validation testing: Not applicable" section further confirms it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Stela Capsule System is a dental restorative system applied directly to the patient's teeth (dentin and enamel). It is not used to analyze blood, urine, tissue, or any other bodily fluid or sample.
- The intended use is for direct dental restoration. The indications for use clearly state its purpose in filling cavities, acting as a base or liner, and core build-ups. These are all clinical procedures performed directly on the patient.
- The device description and performance studies focus on material properties and clinical application. The testing described (biocompatibility, working time, setting time, bond strength, etc.) relates to the material's performance within the oral cavity and its interaction with dental tissues, not its ability to diagnose or provide information about a patient's health status based on a specimen.
Therefore, based on the provided information, the Stela Capsule System is a medical device, specifically a dental restorative material, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Stela Primer: - Dentin and enamel bonding
Stela Capsule
- Direct Class I, II, III and V cavities. Ideally Class I and II
- Base or liner
- Core build-ups.
Product codes
EBF, KLE
Device Description
The Stela Capsule System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises:
- Stela Capsule - a capsule consisting of powder and liquid components which are mixed and activated when the capsule is pushed down. After mixing with a triturator (amalgamator) an applicator is used to dispense the paste.
- Stela Primer an adhesive liquid packaged in a bottle. A bendable disposable brush ● applicator is used to apply Stela Primer.
The combination of Stela Primer and Stela Capsule will bond to both enamel and dentin without scrubbing or light curing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin and enamel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional use
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
Biocompatibility testing:
- Cytotoxicity tests (ISO 7405:2018, ISO 10993-5:2009)
- Delayed-type hypersensitivity (ISO 10993-10:2010)
- Irritation/intracutaneous reactivity (ISO 10993-10:2010)
- Systemic toxicity (ISO 10993-11:2017)
- Genotoxicity (ISO 10993-3:2014)
Results: “The results of the biocompatibility testing and risk assessment demonstrates a low potential for an unacceptable adverse biological response from contact of the component materials of the device with the body.”
Non-clinical performance data (Bench testing):
- Working time (ISO 4049)
- Setting time (ISO 4049)
- Flexural strength (ISO 4049)
- Shade (ISO 4049)
- Colour stability (ISO 4049)
- Radio-opacity (ISO 4049)
- Shear bond strength to dentin (ISO 29022:2013)
- Shear bond strength to enamel (ISO 29022:2013)
Results: “Bench testing demonstrated the Stela Capsule System met the relevant ISO standard requirement, where applicable, and performed comparably to the predicate devices for the parameters tested.”
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
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October 28, 2022
SDI Limited Quynh Jewell Regulatory Affairs Manager 3-15 Brunsdon Street, Bayswater Melbourne, Victoria 3153 Australia
Re: K222583
Trade/Device Name: Stela Capsule System Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, KLE Dated: August 26, 2022 Received: August 26, 2022
Dear Quynh Jewell:
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
Indications for Use
510(k) Number (if known) K22583
Device Name Stela Capsule System
Indications for Use (Describe) Stela Primer: - Dentin and enamel bonding
Stela Capsule
- Direct Class I, II, III and V cavities. Ideally Class I and II
- Base or liner
- Core build-ups.
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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Image /page/3/Picture/0 description: The image shows the letters "SDI" in a black box on the left side of the image. To the right of the black box are the letters "SDI" in a larger font. The letters are in a sans-serif font and are white in color. The background of the image is white.
SDI Limite
Establishment Registration No: 3004140838
PIN: MD6132520
510(k) NOTIFICATION (Traditional): Stela Capsule System – Summary – August 2022
K222583
Submitter Information 1.
SDI Limited 3-15 Brunsdon Street Bayswater, Victoria 3153 Australia
| Contact Person: | Quynh Jewell |
|---|---|
| Position: | Regulatory Affairs Manager |
| Company: | SDI Limited |
| Phone: | +61 3 8727 7111 |
| Email: | Quynh.Jewell@sdi.com.au |
Date Prepared: 9 September 2022
Device Details 2.
The Stela Capsule System comprises the following components:
| Proprietary Name: | Stela Capsule | |
|---|---|---|
| Common Name: | Dental restorative material | |
| Regulation Name: | Tooth shade resin material | |
| Regulation Number: | 872.3690 | |
| Product Code: | EBF | |
| Regulatory Class: | II | |
| Proprietary Name: | Stela Primer | |
| Common Name: | Dental adhesive | |
| Regulation Name: | Resin tooth bonding agent | |
| Regulation Number: | 872.3200 | |
| Product Code: | KLE | |
| Regulatory Class: | II | |
| Proprietary Name: | Application brush | |
| Common Name:Application brush | ||
| Regulation Name: | Resin applicator | |
| Regulation Number: | 872.3140 | |
| Product Code: | KXR | |
| Regulatory Class: | I |
4
510(k) NOTIFICATION (Traditional): Stela Capsule System - Summary - August 2022
Proprietary Name: Common Name: Regulation Name: Regulation Number: Product Code: Regulatory Class:
SDI Applicator Applicator/Dispenser Dental hand instruments 872.4565 DZN |
Predicate Device 3.
| Submitter's Device | Primary Predicate Device | Secondary Predicate Device |
|---|---|---|
| Stela Primer | Name: ParaBond¹ | |
| Manufacturer: Coltene | ||
| 510(k) Number: K053040 | Name: Scotchbond Universal Adhesive² | |
| Manufacturer: 3M ESPE | ||
| 510(k) Number: K110302 | ||
| Stela Capsule | Name: Fill-Up! | |
| Manufacturer: Coltene | ||
| 510(k) Number: K150218 | Name: Filtek Supreme Ultra Universal | |
| Restorative | ||
| Manufacturer: 3M ESPE | ||
| 510(k) Number: K083610 |
1 ParaBond was originally cleared in ParaCem Universal DC 510(k) based on the National Library of Medicine GUDID database noting ParaBond's 510(k) number as K053040.
2 Scotchbond Universal Adhesive was originally cleared as Adhesive EXL 759
No reference devices were used in this submission.
It is noted the application brush is exempt from the premarket notification procedure under Regulation 872.3140. The applicator is exempt from the 510(k) procedure under Regulation 872.4565
Device Description 4.
The Stela Capsule System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises:
- Stela Capsule - a capsule consisting of powder and liquid components which are mixed and activated when the capsule is pushed down. After mixing with a triturator (amalgamator) an applicator is used to dispense the paste.
- Stela Primer an adhesive liquid packaged in a bottle. A bendable disposable brush ● applicator is used to apply Stela Primer.
The combination of Stela Primer and Stela Capsule will bond to both enamel and dentin without scrubbing or light curing.
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Image /page/5/Picture/0 description: The image shows the logo for SDI. On the left side of the image, the letters "SDI" are in white font on a black square. To the right of the square, the letters "SDI" are in black font, followed by the word "Limited".
510(k) NOTIFICATION (Traditional): Stela Capsule System – Summary – August 2022
Indications of Use 5.
The indications for each component of the Stela Capsule System are below.
| Stela Primer | Stela Capsule |
|---|---|
| 1) Dentin and enamel bonding | 1) Direct restoration of Class I, II, III and V |
| cavities. Ideally Class I and II, | |
| 2) Base or liner, | |
| 3) Core build-ups |
For Stela Primer, the indications are identical to the primary predicate. In comparison to the secondary predicate, Stela Primer's indications are phrased in a broad sense whereas the predicate specifies each use. This difference in wording is not expected to alter the intended use nor affect the safety or effectiveness of Stela Primer compared to the secondary
For Stela Capsule, the indications are nearly identical to the primary predicate with the exception of the direct restoration of Class III and IV cavities which are indicated by the secondary predicate according to its Instructions for Use.
Comparison of Technological Characteristics with the Predicate 6. Device
The Stela Capsule System is based on well-established existing self-cure resin technology. The System's two components consist of a 1) combined primer plus bonding agent (Stela Primer) and 2) restorative bulk-fill resin-based material (Stela Capsule).
Stela Primer binds to tooth structure through ionic bonds. Bonding of Stela Primer to Stela Capsule occurs in situ upon contact via polymerisation.
At a high level, the Stela Capsule System has the same technological characteristics as the predicate devices. Where differences exist these are as follows:
- . Stela Primer number of steps
- Similar to Scotchbond Universal Adhesive in that it consists of one bottle O containing the necessary elements to prime and bond; whereas ParaBond consists of three bottles: a conditioner, adhesive A and adhesive B.
- Stela Primer curinq ●
- Self-cure like ParaBond; whereas Scotchbond Universal Adhesive is light O cured.
- Stela Capsule material and curing
- radiopaque bulk-fill composite like both predicates. Stela Capsule is self- O curing while Fill-Up and Filtek Supreme Ultra Universal Restorative are dualcure and light-cure, respectively.
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Image /page/6/Picture/0 description: The image shows the logo for SDI Limited. On the left side of the logo, the letters "SDI" are displayed in white on a black square. To the right of the black square, the words "SDI Limited" are displayed in black on a white background.
510(k) NOTIFICATION (Traditional): Stela Capsule System – Summary – August 2022
7. Performance Data
Biocompatibility testing
The Stela Capsule System is considered an external communicating device in long term contact with tissue/bone/dentin. A biological risk assessment and testing were conducted to assess the biocompatibility of the Stela Capsule System:
- Cytotoxicity tests (ISO 7405:2018, ISO 10993-5:2009) ●
- Delayed-type hypersensitivity (ISO 10993-10:2010)
- Irritation/intracutaneous reactivity (ISO 10993-10:2010) ●
- Systemic toxicity (ISO 10993-11:2017) ●
- Genotoxicity (ISO 10993-3:2014).
The results of the biocompatibility testing and risk assessment demonstrates a low potential for an unacceptable adverse biological response from contact of the component materials of the device with the body.
Non-clinical performance data
Bench testing was conducted to determine the performance of the Stela Capsule System compared to the primary and secondary predicate devices. Testing was conducted on the system where Stela Primer was used in conjunction with Stela Capsule and compared to the equivalent system for the primary and/or secondary predicate device(s). The tests performed were:
- Working time (ISO 4049) ●
- Setting time (ISO 4049)
- Flexural strength (ISO 4049) ●
- Shade (ISO 4049) ●
- Colour stability (ISO 4049) ●
- Radio-opacity (ISO 4049) ●
- Shear bond strength to dentin (ISO 29022:2013) .
- . Shear bond strength to enamel (ISO 29022:2013).
Bench testing demonstrated the Stela Capsule System met the relevant ISO standard requirement, where applicable, and performed comparably to the predicate devices for the parameters tested.
Clinical performance data
This section is not applicable.
Electrical safety and electromagnetic compatibility (EMC)
This section is not applicable.
Software verification and validation testing
This section is not applicable.
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Image /page/7/Picture/0 description: The image shows the logo for SDI Limited. The logo consists of the letters "SDI" in white on a black square. To the right of the square, the words "SDI Limited" are written in black text.
510(k) NOTIFICATION (Traditional): Stela Capsule System – Summary – August 2022
Mechanical and acoustic testing
This section is not applicable.
Conclusion Regarding Substantial Equivalence 8.
A suite of bench and biocompatibility tests shows Stela Capsule System performs comparably to the predicate devices (when used on a system basis) and possesses a low likelihood of an unacceptable adverse biological response from contact of the component materials of the device with the body. The Stela Capsule System's indications for use are identical or very similar to the predicate devices and they are all based on the same restorative materials technology. On this basis, the Stela Capsule System is substantially equivalent to the predicate devices.