(20 days)
Not Found
No
The 510(k) summary describes a dental porcelain system and does not mention any AI or ML components or functionalities.
No
Explanation: The device is a dental porcelain system used for creating fixed prosthodontic devices, which are restorative rather than therapeutic in nature.
No
The device is a dental porcelain system used for veneering and preparing fixed prosthodontic devices, which are restorative rather than diagnostic.
No
The device description explicitly states it consists of physical components (Paste Opaque, Dentine, Enamel, Margin, and Glaze porcelains), which are not software.
Based on the provided information, the CARRARA INTERACTION CERAMIC SYSTEM is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "veneering of metal-ceramic or full ceramic restorative systems." This describes a material used in the creation of dental prosthetics, which are devices implanted or placed in the body.
- Device Description: The description confirms it's a "dental porcelain system used for the preparation of fixed prosthodontic devices." This further reinforces its use in creating dental restorations.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health or condition. The description of the CARRARA system does not involve any such testing or analysis of biological samples.
Therefore, the CARRARA INTERACTION CERAMIC SYSTEM is a dental material used in the fabrication of medical devices (dental prosthetics), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CARRARA INTERACTION CERAMIC SYSTEM is indicated for veneering of metal-ceramic or full ceramic restorative systems.
Product codes
EIH
Device Description
The CARRARA INTERACTION CERAMIC SYSTEM is a dental porcelain system used for the preparation of fixed prosthodontic devices.
The CARRARA INTERACTION CERAMIC SYSTEM consists of Paste Opaque, Dentine, Enamel, Margin, and Glaze porcelains.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Carrara Porcelain and Carrara Vincent Porcelain K981000
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
510(k) SUMMARY
MAR 3 0 2004
DENTSPLY International World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 P. J. Lehn Telefax (717) 849-4343
1 0635
P. Jeffery Lehn CONTACT:
March 8, 2004 DATE PREPARED:
TRADE OR PROPRIETARY NAME: CARRARA INTERACTION CFRAMIC SYSTEM
CLASSIFICATION NAME: Porcelain powder for clinical use (872.6660)
Carrara Porcelain and Carrara Vincent Porcelain K981000 PREDICATE DEVICES:
The CARRARA INTERACTION CERAMIC SYSTEM is a dental DEVICE DESCRIPTION: porcelain system used for the preparation of fixed prosthodontic devices.
The CARRARA INTERACTION CERAMIC SYSTEM consists of Paste Opaque, Dentine, Enamel, Margin, and Glaze porcelains.
INTENDED USE: The CARRARA INTERACTION CERAMIC SYSTEM is indicated for veneering of metal-ceramic or full ceramic restorative systems.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in the CARRARA INTERACTION CERAMIC SYSTEM have been used in legally marketed devices.
The CARRARA INTERACTION CERAMIC SYSTEM is very similar in formulation to legally marketed dental ceramics and has been on the European market since 2002 with over 1 million units placed. The CARRARA INTERACTION CERAMIC SYSTEM is produced from the same frits as Elephant's Carrara (K981000) and Antagon (K982129) Ceramics. Elephant veneering ceramics have been on the market since 1984. Therefore, it was determined that no biocompatibility testing was necessary.
We believe that the prior use of the components of the CARRARA INTERACTION CERAMIC SYSTEM in legally marketed devices, the performance data provided, and the historical use of the device in Europe support the safety and effectiveness of the CARRARA INTERACTION CERAMIC SYSTEM for the intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 2004
Mr. P. Jeffery Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, Pennsylvania 17405-0872
Re: K040635
Trade/Device Name: Carrara Interaction® Ceramic System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: March 08, 2004 Received: March 10, 2004
Dear Mr. Lehn:
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 - Mr. P. Jeffery Lehn
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 Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chris S. Jenkins, Ph.D.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
040635 510(K) Number (if known):
Device Name:
CARRARA INTERACTION CERAMIC SYSTEM
Indications for Use:
The CARRARA INTERACTION CERAMIC SYSTEM is indicated for veneering of metal-ceramic or full ceramic restorative systems.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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)
Suver Ruay
sion of Anesthesiology, General Hospital, Infection Control. Der
510(k) Number