(29 days)
Not Found
No
The document describes dental ceramic materials for veneering crowns and bridges and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a dental ceramic used for veneering crowns and bridges, which are restorative procedures rather than therapeutic in nature.
No
The device is a dental ceramic for veneering crowns and bridges, which is a restorative material used in treatment, not a diagnostic tool.
No
The device description clearly states it is a dental ceramic veneering preparation, which 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 the "Preparation of Crowns and Bridges" by veneering metal frameworks, copings, and pressable ceramics. This is a dental restorative process performed on materials outside the body.
- Device Description: The device is described as "dental ceramic veneering preparation of crowns and bridges" and lists various types of dental porcelains. These are materials used in the fabrication of dental prosthetics.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used in vitro (outside the living body) to analyze biological samples. This device is used ex vivo (on materials outside the body) for the creation of dental restorations.
N/A
Intended Use / Indications for Use
Preparation of Crowns and Bridges:
- Vencering metal framcwork and copings .
- Veneering pressable ceramic .
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
DUCERAGOLD® PORCELAINS are dental ceramic veneering DE VICE DESCRIPTION. preparation of crowns and bridges.
DUCERAGOLD® PORCELAINS include Dentine, Incisal, Transparent, Correction, Powder Opaque, Redox Opaque, Glaze, Shoulder, Paste Opaque, and Bonder porcelains.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K931808 Duccragold
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
510(k) SUMMARY
K04042|
NAME & ADDRESS:
MAR 1 8 2004
DENTSPLY International
World Headquarters Susquenanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 717| 845-7511 (voice) 1767 www.dentsply.com
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
February 17, 2004 DATE PREPARED:
DUCERAGOLD® PORCELAINS TRADE OR PROPRIETARY NAME:
Porcelain powders for clinical use (872.6660) CLASSIFICATION NAME:
K931808 Duccragold PREDICATE DEVICES:
DEVICE DESCRIPTION: DUCERAGOLD® PORCELAINS are dental ceramic veneering DE VICE DESCRIPTION. preparation of crowns and bridges.
DUCERAGOLD® PORCELAINS include Dentine, Incisal, Transparent, Correction, Powder Opaque, Redox Opaque, Glaze, Shoulder, Paste Opaque, and Bonder porcelains.
INTENDED USE: Preparation of crowns and bridges - veneering metal framework and copings, and veneering pressable ceramic.
TECHNOLOGICAL CHARACTERISTICS: found רן ו DUCERAGOLD® PORCELAINS have been used in legally marketed devices.
The formulations of DUCERAGOLD® PORCELAINS are very similar to the legally marketed The Nimalatons of D Changed in any way that would adversely affect biocompatibility. Therefore, it was determined that no additional biocompatibility testing was necessary.
We believe that the prior use of the components in legally marketed devices, the similarity in the formulations that the prior any marketed devices, and the performance data provided support the safety and effectiveness of DUCERAGOI.D® PORCELAINS for the intended use.
G
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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The central image is an eagle with three lines extending from its wing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2004
Dentsply International Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Susquehanna Commerce Center West 221 West Philadelphia Street York, Pennsylvania 17405-0872
Re: K040421
Trade/Device Name: DUCERAGOLD® PORCELAINS Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: February 17, 2004 Received: February 18, 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 mersule commerce prices 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, thereforc, market the device, subject to the general approvisions 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 (1 Writ), it may of backed of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Lederal Register.
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Page 2 -Mr. Lehn
Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements mean that I DA mas made a december and regulations administered by other Federal agencies. of the Act of any I ederal bates and systements, including, but not limited to: registration r ou must comply with art 807); labeling (21 CFR Part 801); good manufacturing practice alla fisting (21 CFR Parvov), and ity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality ajon 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) Fins letter will anow yource of substantial equivalence of your device to a premiarked predicated. - The PDF 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), If you desire speoffice of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other gencral information on your responsibilities under the Act from the may outant outer generational and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runnos
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known): K040421
DUCERAGOLD® PORCELAINS Device Name:
Indications for Use:
Preparation of Crowns and Bridges:
- Vencering metal framcwork and copings .
- Veneering pressable ceramic .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Usc (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)
Kari Murby for WSR
esthesiology, General Hospital, Control. Dental De
510(k) Number:_**_