(90 days)
FluoroCore® 2 is indicated for vital or non-vital tooth core build-up (replacement of existing restorations and/or lost tooth structure) as a base prior to fabricating an indirect restoration and as a post cement.
FluoroGore®, 2 is a fluoride releasing dual cure (chemical and/or light cure), radiopaque two-component core build-up material and post cement. The material is available in two shades and is delivered in double-barrel syringes.
The document provided describes the FluoroCore® 2, a fluoride-releasing, dual-cure, radiopaque two-component core build-up material and post cement. The submission is a 510(k) for substantial equivalence to predicate devices, rather than a de novo approval requiring extensive clinical efficacy studies against acceptance criteria. Therefore, the information typically requested in your prompt regarding acceptance criteria definitions and studies proving those criteria are met is not fully applicable in the context of this 510(k) submission as it would be for a novel medical device demonstrating clinical performance benchmarks.
Instead, this submission focuses on demonstrating substantial equivalence to already approved predicate devices. This means that its acceptance criteria are implicitly met by demonstrating that its technological characteristics, safety, and intended use are similar to those of legally marketed devices.
Here's an breakdown of the information that is available, and what is not present given the nature of a 510(k) submission for substantial equivalence:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: While explicit numerical acceptance criteria for clinical performance (like sensitivity/specificity for an AI device) are not stated, the acceptance criteria for FluoroCore® 2 are centered around biocompatibility and physical properties as per recognized international standards.
- Biocompatibility Acceptance: In accordance with ISO 10993 (Biological evaluation of medical devices) and ISO 7405 (Evaluation of biocompatibility of medical devices used in dentistry).
- Physical Properties Acceptance: In accordance with ISO 4049 (Dentistry - Polymer-based filling, restorative and luting materials).
- Reported Device Performance:
- Biocompatibility: "FluoroCore® 2, including all colorants, has been demonstrated as biocompatible and safe for the same indication and type of tissue contact as the predicate devices."
- Physical Properties: "FluoroCore® 2 complies with ISO 4049."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable/Not provided in the context of this 510(k) submission. No clinical "test set" in the sense of patient data for performance evaluation (like in AI or diagnostic devices) is mentioned. The testing involved international standards for materials, not patient data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not provided. This type of expert ground truth establishment is relevant for diagnostic or AI-driven devices assessing patient conditions, not for material properties testing in a 510(k) for substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This is relevant for studies involving human interpretation or expert consensus on clinical findings, not for materials testing.
5. 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 material, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies are entirely outside the scope of its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: The "ground truth" is adherence to ISO 10993 and ISO 7405 standards for biological safety.
- For physical properties: The "ground truth" is adherence to ISO 4049 standards for dental polymer-based materials.
These are international consensus standards for material science and biological compatibility, not clinical outcomes or expert consensus on patient conditions.
8. The sample size for the training set:
- Not applicable/Not provided. This refers to machine learning, which is not relevant to this device. Material testing often involves specific numbers of samples for each test (e.g., x number of specimens for compressive strength), but these details are not provided in this summary.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. (See point 8).
Study Proving Device Meets Acceptance Criteria:
The document states that the studies performed were:
- Toxicological Testing: Cytotoxicity and genotoxicity tests conducted in accordance with ISO 10993 and ISO 7405. These tests "demonstrated [FluoroCore® 2] as biocompatible and safe" meeting the implicit acceptance criteria of these standards.
- Physical Properties: Testing performed in accordance with ISO 4049. The device "complies with ISO 4049," meeting the implicit acceptance criteria of this standard.
In summary, this 510(k) submission for FluoroCore® 2 relies on demonstrating compliance with recognized international standards for biocompatibility and physical properties of dental materials, rather than clinical performance metrics measured against a "test set" with expert-established ground truth, which is typical for diagnostic or AI-powered devices. The "study" proving acceptance criteria are met is the successful execution of these ISO-compliant tests.
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510(k) SUMMARY for FluoroCore® 2
Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405
DENTSPLY International
World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 (717) 845-7511 (voice) 717] 849-4343 (fax) vww.dentsply.com
FEB 1 0 2009
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |
Date Prepared: November 3, 2008
2. Device Name:
.
- Proprietary Name: .
Classification Name:
FluoroCore® 2
Tooth Shade Resin Material; Dental Cement
- CFR Number:
- Device Class:
- Product Code:
$ 872.3690; § 872.3275 Class II; Class II EBF; EMA
3. Predicate Devices:
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| DENTSPLY International | FluoroCore | K896564 | 9 February 1990 |
| DENTSPLY International | Calibra | K040906 | 16 June 2004 |
Description of Device: 4.
FluoroGore®, 2 is a fluoride releasing dual cure (chemical and/or light cure), radiopaque two-component core build-up material and post cement. The material is available in two shades and is delivered in double-barrel syringes.
న. Indications for Use:
Vital or non-vital tooth core build-up (replacement of existing restorations and/or tooth lost structure) as a base prior to fabricating an indirect restoration and as a post cement.
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Description of Safety and Substantial Equivalence:
Technological Characteristics
The FluoroCore® 2 is substantially equivalent to the predicate devices. The new device and predicate devices are similar in function, composition, and intended use.
Non-Clinical Performance Data
Toxicological Testing
Cytotoxicity and genotoxicity tests were performed in accordance with ISO 10993 and ISO 7405. FluoroCore® 2, including all colorants, has been demonstrated as biocompatible and safe for the same indication and type of tissue contact as the predicate devices.
Physical Properties
Testing was performed in accordance with ISO 4049 (Dentistry - Polymer based filling, restorative and luting materials). FluoroCore® 2 complies with ISO 4049.
Conclusion as to Substantial Equivalence
FluoroCore® 2 is substantially equivalent to the currently marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance & Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404
FEB 1 0 2009
Re: K083326
Trade/Device Name: FluoroCore® 2 Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF, EMA Dated: November 3, 2008 Received: November 12, 2008
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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
USA november Ginette Y. Michaud, M.D. Acting 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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: FluoroCore 2
Indications for Use:
FluoroCore® 2 is indicated for vital or non-vital tooth core build-up (replacement of existing restorations and/or lost tooth structure) as a base prior to fabricating an indirect restoration and as a post cement.
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)
Sura Runne
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083326
DENTSPLY International
FluoroCore® 2
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§ 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.