(29 days)
No
The 510(k) summary describes a ceramic veneering system and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No.
The device is described as an all-ceramic system for veneering, indicating it is a material used in dental restorations, not a therapeutic device designed to treat a medical condition. Its predicate device is also a dental porcelain, reinforcing its classification as a material rather than a therapeutic device.
No
The device is described as an all-ceramic system for veneering, indicating it is a material for dental restorations rather than a diagnostic tool. Its intended use is for "veneering of aluminum oxide cores or tooth preparations," which are restorative procedures. There is no mention of it detecting, diagnosing, or characterizing any disease or condition.
No
The device description clearly states it is an "all-ceramic system" for veneering, indicating 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 "veneering of aluminum oxide cores or tooth preparations." This describes a material used in dental restorations, applied directly to the tooth or a core structure.
- Device Description: The description confirms it's an "all-ceramic system for veneering." This further reinforces its use as a dental material.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, Ducera® AllCeram is a dental material used for restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ducera® AllCeram is an all-ceramic system for veneering of aluminum oxide cores or tooth preparations.
Ducera® AllCeram is indicated for veneering of aluminum oxide cores or tooth preparations.
Product codes
EIH
Device Description
Ducera® AllCeram is an all-ceramic system for veneering of aluminum oxide cores or tooth preparations.
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
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VITADUR® ALPHA Porcelain K921623
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
11043247 510(k) SUMMARY
DEC 22 2004
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
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| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | November 16, 2004 |
| TRADE OR PROPRIETARY NAME: | Ducera® AllCeram |
| CLASSIFICATION NAME: | Porcelain powders for clinical use (872.6660) |
| PREDICATE DEVICES: | VITADUR® ALPHA Porcelain K921623 |
DEVICE DESCRIPTION: Ducera® AllCeram is an all-ceramic system for veneering of aluminum oxide cores or tooth preparations.
INTENDED USE: Ducera® AllCeram is an all-ceramic system for veneering of aluminum oxide cores or tooth preparations.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in Ducera® AllCeram have been used in legally marketed devices.
Because of the nearly equivalent material composition of Ducera® AllCeram to the predicate device, no additional toxicity testing was necessary.
We believe that the prior use of the components in legally marketed devices, the similarity in the formulations to those legally marketed devices, and the performance data provided support the safety and effectiveness of Ducera® AllCeram for the intended use.
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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 2004
Ms. Helen Lewis Director, Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K043247
Trade/Device Name: Ducera® AllCeram Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 16, 2004 Received: November 23, 2004
Dear Ms. Lewis:
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 -- Ms. Helen Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be duvised made a determination that your device complies with other requirements of the Act or that I Dr. I has mude a deceministered 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); an the Act 3 requirements, morading, offacturing practice requirements as set forth in the quality fabeling (21 CFR Part 801); good for 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) I mis letter with and w yourse FDA finding of substantial equivalence of your device to a legally premaince nouteation - 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 ir you don't the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other Whoolunding of Ferences on your responsibilities under the Act from the Division of Small general miorination of your of Journer Assistance at its toll-free number (800) 638-2041 or 1301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
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
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INDICATIONS FOR USE
1104 3247 510(k) Number (if known):
Device Name: Ducera® AllCeram
Indications For Use:
Ducera® AllCeram is indicated for veneering of aluminum oxide cores or tooth preparations.
Prescription Use __X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Runne
Division Infectio
physiology, General Hospital,
Dental Devices
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