(49 days)
Paint-on Polish Agent is indicated for
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- Surface and enamel margin treatment of Direct, light-cured composite restorations.
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- Surface treatment of Indirect restorations; composite resin or methacrylate veneers, inlays, onlays, crown and bridge retainers.
The Paint-on Polish Agent is liquid Polish agent designed eliminate the Polishing procedure by painting the formulation on the surface of restorations directly. It is indicated for use on both permanent and temporary restorations. Paint-on Polish can also be used as a sealant to decrease the micro-leakage at tooth-composite restoration interface. Due to the unique chemistry, Paint-on Polish formulation can be cured by both LED and halogen light. The addition of fillers provides excellent wear resistance for the formulation. The cured coating surface has a strong adhesion to restoration and excellent stain resistance to food and drinks. It also emits blue fluorescence close to enamel surface. Paint-on Polish formulation has a thin oxygen inhibited layer after curing, but it can be easily removed by ethanol or isopropanol without reducing the glossiness of coating.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics for the DENTSPLY International Paint-on Polish Agent (K670306). The document is a 510(k) summary for a dental device, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results against pre-defined acceptance criteria for a new clinical study.
However, based on the type of information typically found in such submissions and what is hinted at, I can construct a response that addresses your points where possible, and clearly states when information is not available in the provided text.
Here's an attempt to answer your request based only on the provided text:
Acceptance Criteria and Device Performance Study for DENTSPLY International Paint-on Polish Agent (K670306)
The provided submission (K670306) is a 510(k) summary demonstrating substantial equivalence for a dental coating material. While the document mentions performance data, it does not detail specific acceptance criteria or an analytical study with quantitative performance metrics against those criteria in the format requested. The evaluation primarily relies on the prior use of components and biocompatibility testing. No information on a specific, quantitative performance study with defined acceptance criteria is supplied within these documents.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Wear Resistance | (Not specified) | "Excellent wear resistance for the formulation." (Qualitative) |
| Adhesion to Restoration | (Not specified) | "Strong adhesion to restoration." (Qualitative) |
| Stain Resistance | (Not specified) | "Excellent stain resistance to food and drinks." (Qualitative) |
| Biocompatibility | (Not specified) | "Evaluated and passed biocompatibility testing for cytotoxicity, genotoxicity, irritation and sensitization." (Pass/Fail) |
| Curing by LED/Halogen Light | (Not specified) | "Can be cured by both LED and halogen light." (Functional claim) |
| Oxygen Inhibited Layer | (Not specified) | "Thin oxygen inhibited layer after curing, but it can be easily removed by ethanol or isopropanol without reducing the glossiness of coating." (Functional claim) |
| Fluorescence | (Not specified) | "Emits blue fluorescence close to enamel surface." (Functional claim) |
Note: The document largely provides qualitative descriptions of performance rather than specific, measurable acceptance criteria or quantitative results.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided text. The document refers to "performance data," but does not specify sample sizes for any test set or the provenance (country of origin, retrospective/prospective) of this data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not available in the provided text. The submission focuses on product characteristics and biocompatibility, not expert-adjudicated performance studies.
4. Adjudication Method for the Test Set
This information is not available in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information on an MRMC comparative effectiveness study, or the effect size of human readers improving with or without AI assistance, is provided. This type of study is not relevant to the described device.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
No information on a standalone performance study is provided. This device is a dental material, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance claims appears to be based on laboratory testing (e.g., for wear, adhesion, stain resistance, and biocompatibility). The document does not specify if clinical outcomes or pathology reports were used to establish efficacy in the context of a clinical study.
8. Sample Size for the Training Set
This information is not available in the provided text. The device is a material, not an algorithm that would typically have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not available in the provided text. As above, this concept (training set and its ground truth) is not applicable to the description of this dental material.
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SECTION 5: 510(k) SUMMARY
MAR 2 2 2007
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | January 30, 2007 |
| TRADE OR PROPRIETARY NAME: | Paint-on Polish Agent |
| CLASSIFICATION NAME: | Coating Material for Resin Fillings,Class II per 21CFR872.3310 |
| PREDICATE DEVICES: | Biscover LV. K043168. |
DEVICE DESCRIPTION:
The Paint-on Polish Agent is liquid Polish agent designed eliminate the Polishing procedure by painting the formulation on the surface of restorations directly. It is indicated for use on both permanent and temporary restorations. Paint-on Polish can also be used as a sealant to decrease the micro-leakage at tooth-composite restoration interface. Due to the unique chemistry, Paint-on Polish formulation can be cured by both LED and halogen light. The addition of fillers provides excellent wear resistance for the formulation. The cured coating surface has a strong adhesion to restoration and excellent stain resistance to food and drinks. It also emits blue fluorescence close to enamel surface. Paint-on Polish formulation has a thin oxygen inhibited layer after curing, but it can be easily removed by ethanol or isopropanol without reducing the glossiness of coating.
INTENDED USE:
- Surface and enamel margin treatment of Direct, light-cured composite restorations. 1.
- Surface treatment of Indirect restorations; composite resin or methacrylate veneers, 2. inlays, onlays, crown and bridge retainers.
TECHNOLOGICAL CHARACTERISTICS:
All of the components found in Paint-on Polish Agent have been used in legally marketed devices and were found safe for dental use. Paint-on Polish has been evaluated and passed biocompatibility testing for cytoxicity, genotoxicity, irritation and sensitization.
We believe that the prior use of the components of Paint-on Polish in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of Paint-on Polish for the indicated uses.
000010
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
MAR 2 & 2007
Re: K070306
Trade/Device Name: Paint-on Polish Agent Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: January 30, 2007 Received: February 09, 2007
Dear Ms. Lewis:
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.
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Page 2 - Ms. Helen Lewis
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); 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4: INDICATIONS FOR USE
K07 0306
510(k) Number (if known):
Device Name: Paint-on Polish Agent
Indications for Use:
Paint-on Polish Agent is indicated for
-
- Surface and enamel margin treatment of Direct, light-cured composite restorations.
-
- Surface treatment of Indirect restorations; composite resin or methacrylate veneers, inlays, onlays, crown and bridge retainers.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sver Qumne
...tion Cont...
70304
00009
Paint-on Polish Agent
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.