(85 days)
Not Found
No
The summary describes a system of ceramic materials and liquids used for fabricating dental prostheses, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is used to fabricate dental prostheses, which replace missing or damaged teeth, but it does not directly treat a disease or condition.
No
The device is a ceramic system used by dental technicians to fabricate prostheses for missing/damaged teeth. It is a restorative material, not a device used to diagnose a medical condition.
No
The device description explicitly states the device consists of "pressable silica based ceramic pellets and silica based ceramic layering porcelain and liquids," which are physical materials, 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 to fabricate dental prostheses (crowns and bridges) for missing/damaged teeth. This is a restorative dental application, not a diagnostic test performed on biological samples in vitro.
- Device Description: The device consists of ceramic materials used for fabrication. These are materials used to build a physical structure, not reagents or instruments used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is clearly intended for the fabrication of dental prostheses, which falls under the category of medical devices used for treatment and restoration, not diagnosis.
N/A
Intended Use / Indications for Use
The pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
The InSync Ceramic System consists of pressable silica based ceramic pellets and silica based ceramic layering porcelain and liquids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technicians
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)
Data has been presented to demonstrate that the respective composition, mechanical properties, chemical qualities, and the indications for use make the InSync Ceramic System substantially cquivalent to the predicate devices Willi Geller Creation CP-Zi and Ceramics 2in1porcelains The safety and effectiveness of the InSync Ceramic System, being determined by the shared chemical qualities and mechanical properties, is therefore equivalent to the predicate devices. Independantly, the InSync Ceramic System meets the applicable sections of concensus standards ISO 9693 and ISO 6872.
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
§ 872.6660 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
Image /page/0/Picture/0 description: The image shows the logo for Jensen Dental. The logo consists of a stylized water droplet shape on the left, followed by the word "JENSEN" in large, bold, sans-serif font. Below the word "JENSEN" is the word "DENTAL" in a smaller, simpler font.
i
1 4 2011
Section E
510(k) SUMMARY
| Submitted by: | Jensen Industries
50 Stillman Road
North Haven CT 06473
(203) 239-2090 phone
(203) 234-7630 fax
Contact: Gary Phelps |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | June 14, 2011 |
| Device Name: | The InSync Ceramic System |
| Common Name: | Dental Porcelain |
| Classification Name: | Porcelain powder for clinical use (21 CFR 872.6660) |
| Classification: | Class II |
| Product Code: | EIH |
Predicate Devices
| Ceramics 2in1: 510(k) number K043221 | |
|---|---|
| Willi Geller Creation CP - ZI: 510(k) number K070114 |
Device Description
The InSync Ceramic System consists of pressable silica based ceramic pellets and silica based ceramic layering porcelain and liquids.
Indications for use
The pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.
Comparison to predicate devices
Data has been presented to demonstrate that the respective composition, mechanical properties, chemical qualities, and the indications for use make the InSync Ceramic System substantially cquivalent to the predicate devices Willi Geller Creation CP-Zi and Ceramics 2in1porcelains The safety and effectiveness of the InSync Ceramic System, being determined by the shared chemical qualities and mechanical properties, is therefore equivalent to the predicate devices. Independantly, the InSync Ceramic System meets the applicable sections of concensus standards ISO 9693 and ISO 6872.
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50 Stillman Road, North Haven, CT 06473 JENSEN DENTAL
(203) 239-7630 Fax (203) 239-2090 www.jensendental.com (800) 243-2000
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health. The caduceus is composed of three wavy lines that resemble snakes intertwined around a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Gary Phelps Quality Assurance Manager Jensen Industries. Incorporated 50 Stillman Road North Haven. Connecticut 06473
SEP 14 200
Re: K111743
Trade/Device Name: The InSync Ceramic System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EHH Dated: June 06, 2011 Received: June 21, 2011
Dear Mr. Phelps:
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 111 (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 - Mr. Phelps
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 331-542 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.ida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/acm115809.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.lda.gov/MedicalDevices/Safety/ReportaProblem/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.hun.
Sincerely vours.
hh 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 Radiolo@ical Health
Enclosure
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Indications for Use
510(k) Number (if known):
K | | 743
Device Name: The InSync Ceramic System
Indications for Use: The pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rooney
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111743
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