(63 days)
Stela Primer:
- Dentin and enamel bonding
Stela Automix:
- Direct Class I, II, III and V cavities. Ideally Class I and II.
- Base or liner
- Core build-ups.
The Stela Automix System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises:
- Stela Automix a double-barrel syringe containing two pastes which are mixed and dispensed with a single-use mixing tip and
- 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 Automix will bond to both enamel and dentin without scrubbing or light curing.
The provided text describes a 510(k) premarket notification for a dental device (Stela Automix System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving the device meets specific performance acceptance criteria for an AI/ML medical device or a new type of device.
Therefore, the document does not contain the information needed to answer your request about acceptance criteria, study design for AI/ML performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies.
The document primarily discusses:
- Biocompatibility testing: To ensure the device materials are safe for biological contact.
- Non-clinical performance data (bench testing): To compare the physical and chemical properties of the Stela Automix System to predicate devices and ensure it meets relevant ISO standards (e.g., working time, setting time, flexural strength, shade, color stability, radio-opacity, shear bond strength).
No information regarding AI/ML device performance, human-in-the-loop studies, or the statistical details usually associated with such studies (like sample size for test sets, number of experts for ground truth, adjudication methods, or training set details) is present because this is not an AI/ML device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 28, 2022
SDI Limited Quynh Jewell Regulatory Affairs Manager 3-15 Brunsdon Street, Bayswater Melbourne, Victoria 3153 Australia
Re: K222581
Trade/Device Name: Stela Automix 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) K222581
Device Name Stela Automix System
Indications for Use (Describe) Stela Primer: - Dentin and enamel bonding
Stela Automix:
- 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the letters "SDI" in a black square, followed by the letter "s" in a larger font size. The letters "SDI" are white and bolded. The letter "s" is also bolded and appears to be part of a word that is cut off.
SDI Limite
Establishment Registration No: 3004140838
PIN: MD6132486
510(k) NOTIFICATION (Traditional): Stela Automix System – Summary – August 2022
K222581
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 Automix System comprises the following components:
| Proprietary Name: | Stela Automix |
|---|---|
| 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: | Mixing tip and application brush |
| Common Name: | Mixing tip and application brush |
| Regulation Name: | Resin applicator |
| Regulation Number: | 872.3140 |
| Product Code: | KXR |
| Regulatory Class: | I |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for SDI Limited. The logo consists of the letters "SDI" in a bold, sans-serif font, set against a black square. To the right of the square, the words "SDI Limited" are written in a smaller, regular font.
510(k) NOTIFICATION (Traditional): Stela Automix System – Summary – August 2022
ന് Predicate Device
| Submitter's Device | Primary Predicate Device | Secondary Predicate Device |
|---|---|---|
| Stela Primer | Name: ParaBond1Manufacturer: Coltene510(k) Number: K053040 | Name: Scotchbond Universal Adhesive2Manufacturer: 3M ESPE510(k) Number: K110302 |
| Stela Automix | Name: Fill-Up!Manufacturer: Coltene510(k) Number: K150218 | Name: Filtek Supreme Ultra UniversalRestorativeManufacturer: 3M ESPE510(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 mixing tip and application brush are exempt from the premarket notification procedure under Regulation 872.3140.
4. Device Description
The Stela Automix System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises:
- Stela Automix a double-barrel syringe containing two pastes which are mixed and . dispensed with a single-use mixing tip and
- 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 Automix will bond to both enamel and dentin without scrubbing or light curing.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image contains the logo for SDI Limited. The logo consists of the letters "SDI" in a bold, sans-serif font, set against a black square. To the right of the black square, the words "SDI Limited" are written in a smaller, less bold font.
510(k) NOTIFICATION (Traditional): Stela Automix System – Summary – August 2022
Indications of Use ട.
The indications for each component of the Stela Automix System are below.
Stela Primer
-
Dentin and enamel bonding
-
Direct restoration of Class I, II, III and V cavities. Ideally Class I and II,
-
Base or liner,
Stela Automix
-
- 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
- Core build-ups
For Stela Automix, 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 Automix 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 Automix).
Stela Primer binds to tooth structure through ionic bonds. Bonding of Stela Primer to Stela Automix occurs in situ upon contact via polymerisation.
At a high level, the Stela Automix 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 curing ●
- Self-cure like ParaBond; whereas Scotchbond Universal Adhesive is light O cured.
- Stela Automix material and curing
- radiopaque bulk-fill composite like both predicates. Stela Automix is self-O curing while Fill-Up and Filtek Supreme Ultra Universal Restorative are dualcure and light-cure, respectively.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for SDI Limited. The logo consists of the letters "SDI" in white on a black square, followed by the words "SDI Limited" in a smaller, sans-serif font. The text is aligned horizontally, with the black square on the left and the company name on the right.
510(k) NOTIFICATION (Traditional): Stela Automix System – Summary – August 2022
7. Performance Data
Biocompatibility testing
The Stela Automix 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 Automix 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 Automix System compared to the primary and secondary predicate devices. Testing was conducted on the system where Stela Primer was used in conjunction with Stela Automix 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 Automix 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.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for SDI Limited. The logo consists of the letters "SDI" in a bold, sans-serif font on a black background. To the right of the black box, the words "SDI Limited" are written in a smaller, less bold font on a white background. The overall design is simple and professional.
510(k) NOTIFICATION (Traditional): Stela Automix 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 Automix 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 Automix 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 Automix System is substantially equivalent to the predicate devices.
§ 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.