Fluorcanasite is a CAD/CAM machinable glass ceramic block, batched from standard glass-making ingredients which are intended to be used by trained professionals in a dentist's office for the manufacture of all-ceramic inlays, onlays, crowns, and veneers.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental ceramic device named "Fluorcanasite Dental Ceramic" (K100794). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and performance studies in the way one might see for AI/ML devices or novel therapies.

Therefore, the study design elements typically requested for AI/ML or clinical trials (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable to this submission. The "study" here is a series of non-clinical, benchtop tests designed to characterize the material properties of the new device and compare them to a predicate device.

Here's an analysis based on the information provided, specifically addressing the criteria where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission are generally that the new device performs "as well as, or better than" the predicate device for relevant characteristics, demonstrating substantial equivalence. The predicate device's performance often serves as the de facto benchmark.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Fluorcanasite)
Biaxial Flexural Strength	Comparable to or greater than 360 MPa (Predicate: IPS e. max CAD)	271.3 MPa
CTE	Comparable to 10.45 ppm/°C (Predicate: IPS e. max CAD)	8.8 ppm/°C
Chemical Solubility	Comparable to or less than 30-50 µg/cm² (Predicate: IPS e. max CAD)	722 µg/cm²
Fracture Toughness	Comparable to or greater than 2.0-2.5 MPa m1/2 (Predicate: IPS e. max CAD)	4.2 MPa m1/2
Hardness	Comparable to 5.94 GPa (Predicate: IPS e. max CAD)	5.18 GPa
MTBS (ceramic composite)	N/A (Predicate not applicable or reported)	27.59 MPa
Biocompatibility	Meets ISO 10993-5 standards	Meets ISO 10993-5 standards
Uranium Content	Low/negligible activity concentration (Specific limits not stated, but results show very low/undetectable levels)	<10 Bq/kg (Total), <7.0 µg/kg (Total)

Note on "Acceptance Criteria": For a 510(k) like this, specific numerical acceptance criteria (e.g., "must be > X MPa") are often derived from recognized standards (like ISO 6872:2008) or from the predicate device's published properties. The conclusion states "Fluorcanasite performed as well as, or better than, the predicate device," which is the overall acceptance criterion for substantial equivalence. It's important to note that while some values are numerically "worse" than the predicate (e.g., lower flexural strength, higher solubility), the FDA determined substantial equivalence based on the totality of the data and the overall intended use, suggesting these differences were not deemed to raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated as a number of "samples" in a clinical human-subject sense. The non-clinical tests (Biaxial Flexural Strength, CTE, Chemical Solubility, Fracture Toughness, Hardness, MTBS, Biocompatibility, Uranium content) would have involved multiple specimens of the material as per the test methodologies (e.g., ISO standards), but the exact number of specimens is not provided.
Data Provenance: The non-clinical testing was conducted, and the summary was prepared in the UK (Applicant address: Derbyshire, UK). The Uranium content analysis was managed under "NPL LRQA registration to ISO 9001:2000," indicating a UK National Physical Laboratory (NPL) involvement.
Retrospective or Prospective: N/A for benchtop material testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Experts: Not applicable. Ground truth, in this context, is established by adherence to recognized international standards (e.g., ISO 6872:2008, ISO 10993-5) for material property measurements and radiochemical analysis methodologies.
Qualifications: Not applicable for this type of submission. The qualifications would be implied by the accreditation and expertise of the laboratories conducting the standardized tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving subjective human interpretation that would require an adjudication method. The measurements are objective material properties.

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 is a dental ceramic material, not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a dental ceramic material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is derived from standardized material testing methodologies (e.g., ISO 6872:2008, ISO 10993-5) and analytical chemistry techniques (for uranium content), which provide objective, measurable physical and chemical properties of the material.
The "truth" of comparability is then assessed against the predicate device's reported properties.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set."

Summary

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K100794

SECTION 5 - 510(k) Summary

JAN 2 5 2011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

APPLICANT: Dr. Sarah Pollington

ADDRESS: Redbank, Ashopton Road, Bamford, Hope Valley, Derbyshire, S33 0AZ UK

PHONE: +44 (0) 1433 65 1541

CONTACT PERSON: Dr. Sarah Pollington

OFFICIAL CORRESPONDENT: Ms. Judy Burton, Advena Ltd.

ADDRESS OF CORRESPONDENT: 3010 Valley View Lane, 12th Floor, Dallas, Texas 75234

CORRESPONDENT PHONE: (972) 243-5105

CORRESPONDENT FAX: (972) 243-1542

DATE OF SUMMARY: November 19, 2010

TRADE NAME: Fluorcanasite Dental Ceramic

COMMON NAME: Dental Ceramic

CLASSIFICATION NAME: Porcelein Powder for Clinical Use

CLASSIFICATION CODE: EIH

REGULATION NO .: 872.6660

PREDICATE DEVICE: K051705 IPS E. Max CAD

CLASSIFICATION CODE: EIH

REGULATION NO.: 872.6660

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DEVICE DESCRIPTION: Fluorcanasite is a CAD/CAM machinable glass ceramic block, batched from standard glass-making ingredients which are intended to be used by trained professionals in a dentist's office for the manufacture of all-ceramic inlays, onlays, crowns, and veneers.

DEVICE COMPARISON:

	New Device	Predicate Device
510(k) Number		K051705
Device Name, Model	Fluorcanasite	IPS e. max CAD(lithium disilicate)
Manufacturer	Dr. Sarah Pollington	Ivoclar Vivadent, Inc.
Intended Use	A ceramic material to beused for machining into toothcores that are then veneeredand secured by a specificadhesive to the dentine of apatient's modified andprepared tooth.	IPS e. max CAD is a CAD/CAMmachinable glass ceramicbased on lithium disilicate forthe preparation of full ceramiccrowns, inlays, onlays, and fullceramic 3-unit anteriorbridges.
Biaxial flexural strength	271.3 MPa	360 MPa
CTE	8.8 ppm/°C	10.45 ppm/°C
Chemical solubility	722 ug/cm²	30-50 ug/cm²
Fracture toughness	4.2 MPa m1/2	2.0-2.5 MPa m1/2
Hardness	5.18 GPa	5.94 GPa
MTBS (ceramic composite)	27.59 MPa	n/a

INTENDED USE: Fluorcanasite is a CAD/CAM machinable glass ceramic block, batched from standard glass-making ingredients which are intended to be used by trained professionals in a dentist's office for the manufacture of all-ceramic inlays, onlays, crowns, and veneers.

TECHNOLOGICAL CHARACTERISTICS: Fluorcanasite is a multiple chain-silicate glass-ceramic comprised of sodium carbonate, potassium carbonate, calcium carbonate, calcium fluoride, Loch Aline sand (high purity silica) and zirconia. Its properties display high strength and fracture toughness and the potential as an indirect resin-bonded dental restoration.

CLINICAL TESTING: Non-clinical test data was used to support the devices safety and effectiveness.

NON-CLINICAL TESTING: Fluorcanasite was subjected to the following non-clinical testing:

. ISO 6872:2008: Biaxial Flexural Strength, Fracture Toughness and Clinical Solubility;
. Vickers Hardness: Thermal Shock, Hardness and Brittleness Index, and Shelf Life;
ISO 10993-5: Biocompatibility; and,
. XRD and SEM - Crystalline Phase and Microstructural Analysis

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with the result that Fluorcanasite performed as well as, or better than, the predicate device.

OTHER INFORMATION DEEMED NECESSARY BY FDA: A sample of dental restorative glass powder was analysed for uranium content. The results of the radiochemical analysis are tabulated on the following, with uncertainties quoted with a coverage factor of k=2, providing a level of confidence of approximately 95%. This work was managed under the NPL LRQA registration to ISO 9001:2000.

Uranium was measured in this sample by initial dissolution in mineral acids, followed by ion exchange separation of uranium. The separated uranium was electrodeposited onto a stainless steel disc, which was then measured using a-particle spectrometry. Standardised 2320 was added as a chemical yield tracer for the analysis.

NPL identifier	Nuclide	Activity concentration	Mass concentration1
		Bq/kg	μg/kg
IM0900	234U	<8	<0.035
	235U	<1	<0.51
	238U	<1	<6.5
	Total	<10	<7.0

CONCLUSION:

The testing indicates that Fluorcanasite is safe and effective for its intended use and performs as well or better than the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is an abstract symbol that resembles three stylized human figures or waves.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dr. Sarah Pollington C/O Ms. Judy Burton Advena Limited 3010 LBJ Freeway, 12th Floor Dallas, Texas 75234

JAN 2 5 2011

Re: K100794

Trade/Device Name: Fluorcanasite Dental Ceramic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 14, 2011 Received: January 21, 2011

Dear Ms. Burton:

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. 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.

. . . .

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Page 2- Ms. Burton

Enclosure

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): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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SECTION 4 - Indications for Use Statement

Indications for Use

510(k) Number (if known): K100794

Device Name: Fluorcanasite Dental Ceramic

Fluorcanasite is a CAD/CAM machinable glass ceramic block, batched from standard glassmaking ingredients which are intended to be used by trained professionals in a dentist's office for the manufacture of all-ceramic inlays, onlays, crowns, and veneers.

Prescription Use (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 IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of __

Susan Quare

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of Antonio - Dental Devices

510(k) Number:

4-1

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.