(309 days)
Not Found
No
The summary describes a ceramic block for dental restorations and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is a material (ceramic block) used to manufacture dental restorations, not a device that directly provides therapy or treatment.
No
The device is described as a material (glass ceramic block) used for manufacturing dental restorations, not for diagnosing medical conditions.
No
The device is a physical ceramic block used for manufacturing dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the manufacture of dental restorations (inlays, onlays, crowns, and veneers) for use in the patient's mouth.
- Device Description: It's a material used to create physical dental prosthetics.
- Lack of Diagnostic Purpose: There is no mention of this device being used to diagnose a disease or condition, or to examine specimens derived from the human body.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device is a material used to create a physical restoration for the tooth.
N/A
Intended Use / Indications for 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.
Product codes
EIH
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.
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
Trained professionals in a dentist's office
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
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
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.
Key Metrics
Not Found
Predicate Device(s)
K051705 IPS E. Max CAD
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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 be | |
| used for machining into tooth | ||
| cores that are then veneered | ||
| and secured by a specific | ||
| adhesive to the dentine of a | ||
| patient's modified and | ||
| prepared tooth. | IPS e. max CAD is a CAD/CAM | |
| machinable glass ceramic | ||
| based on lithium disilicate for | ||
| the preparation of full ceramic | ||
| crowns, inlays, onlays, and full | ||
| ceramic 3-unit anterior | ||
| bridges. | ||
| 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
2
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 |