(90 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a core build-up material and post cement, with no mention of AI or ML technologies.
No
The device is a core build-up material and post cement used in dentistry to replace lost tooth structure and secure posts, which is a restorative and structural function, not a therapeutic one.
No
The device is described as a material for tooth core build-up and post cement, replacing lost tooth structure. Its indications for use and device description focus on restorative and structural purposes, not on diagnosing medical conditions or diseases.
No
The device description clearly states it is a "two-component core build-up material and post cement" delivered in "double-barrel syringes," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "vital or non-vital tooth core build-up" and "post cement." This describes a material used directly on or within the tooth for structural restoration and bonding.
- Device Description: The description details a "fluoride releasing dual cure... core build-up material and post cement." This further confirms its use as a dental restorative and bonding agent.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition. IVDs are specifically designed for diagnostic purposes.
The device described is a dental material used for treatment and restoration, not for in vitro diagnosis.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EBF, EMA
Device Description
FluoroCore®, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the word "DENTSPLY" in all caps. The font is bold and black. The letters are close together, and the word is slightly angled upwards from left to right. The background is white.
Image /page/0/Picture/1 description: The image contains a sequence of handwritten alphanumeric characters. The characters appear to be 'K0833326'. The characters are written in a cursive style, with some connections between the letters and numbers. The image has a white background.
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.
1
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.
2
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.
3
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
4
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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