(57 days)
Starflow HV is intended for use for the restoration of Class III, Class IV, and Class V cavities, small Class I cavities not in occlusion, repair of enamel defects, repair of porcelain restorations, minor occusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for seramic/composite veneers, incisal abrasions, and core build-ups.
Starflow HV is a light-cured, hybrid dental retorative which incorporates BIS/GMA resin along with Barium aluminosilicate glass filler (64% by wt) to yield a flowable dental restorative.
The provided text is a 510(k) summary for the Starflow HV device, which is a dental restorative material. This type of regulatory submission focuses on demonstrating substantial equivalence to pre-existing devices rather than independent clinical studies with specific acceptance criteria and detailed performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The 510(k) summary describes the device, its intended use, and identifies predicate devices (Revolution by Sybron Dental Specialties (K013647), StarFlow by Danville Materials Inc (K990108), and Tetric Flow (K 993783) by Ivoclar Vivadent) to which it claims substantial equivalence. The primary difference noted is "very minor changes to the material composition."
To address the specific points of your request:
- A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence based on material composition and intended use, not on specific performance metrics with predefined acceptance criteria.
- Sample size used for the test set and the data provenance: Not present. No test set or associated data is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment for a test set is mentioned.
- Adjudication method: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental restorative material, not an AI-powered diagnostic or assistive tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used: Not applicable for a performance study. For regulatory purposes, the "ground truth" for substantial equivalence is demonstrating that the new device is as safe and effective as a legally marketed predecessor.
- The sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable.
In conclusion, this 510(k) submission does not provide the kind of detailed study information (acceptance criteria, performance data, specific study design, expert involvement) that would be found in a clinical trial report or a submission for a novel, high-risk device. The regulatory pathway chosen for Starflow HV relies on demonstrating that it is fundamentally similar to existing, legally marketed dental restorative materials.
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MAY 0 3 2002
510(k) Summary of Safety and Effectiveness (As Required by 21 C.F.R. §807.92)
| Submitted by: | Craig BrunsVice PresidentDanville Materials, Inc.2021 Omega Dr.San Ramon, CA 94583Phone 925 838-7940Fax 925 838-0944e-mail: cbruns@daneng.com |
|---|---|
| Date of summary | February 14, 2002 |
| Device name | Starflow HV |
| Common name | Tooth Shade Resin Material |
| Classification names | Regulation Number |
| 21 CFR 872.3690 | |
| Product Code | |
| EBF | |
| Device Description | Starflow HV is a light-cured, hybrid dental retorative which incorporatesBIS/GMA resin along with Barium aluminosilicate glass filler (64% by wt) toyield a flowable dental restorative. |
| Predicate Device | The device is substantially equivalent to other legally marketed devices in theUnited States including Revolution by Sybron Dental Specialties (K013647),StarFlow by Danville Materials Inc (K990108), and Tetric Flow (K 993783) byIvoclar Vivadent. The primary differences are very minor changes to thematerial composition. |
| Intended Use | Starflow HV is intended for use for the restoration of Class III, Class IV, andClass V cavities, small Class I cavities not in occlusion, repair of enameldefects, repair of porcelain restorations, minor occusal build-ups in non-stressbearing areas, pit and fissure sealant, cement for seramic/composite veneers,incisal abrasions, and core build-ups. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 3 2002
Mr. Craig R. Bruns Vice President & General Manager Danville Materials, Incorporated 2021 Omega Drive San Ramon, California 94583
Re: K020760
Trade/Device Name: Starflow HV Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF Dated: February 20, 2002 Received: March 07, 2002
Dear Mr. Bruns:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Craig R. Bruns
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental. Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page / of /
1020760
510(k) Number:
Device Name: Starflow HV
Indications for use:
Starflow HV is intended for use for the restoration of Class IV, and Class V cavities, small Class Daarrow 11-11-15 in occlusion, repair of enamel defects, repair of porcelain restorations, minor occusal buildr variato not in obtained, reas, pit and fissure sealant, cement for seramic/composite veneers, incisal abrasions, and core build-ups.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K020760 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)
ರಿ
§ 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.