(29 days)
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.
Ducera® AllCeram is an all-ceramic system for veneering of aluminum oxide cores or tooth preparations.
The provided document is a 510(k) summary for a dental product, Ducera® AllCeram. It does not contain information about a study that assesses device performance against acceptance criteria in the way typically expected for medical imaging AI or diagnostic devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on material composition and prior use of components.
Therefore, many of the requested sections about study design, sample sizes, expert involvement, and ground truth establishment are not applicable.
Here's the information that can be extracted or inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or performance metrics for the Ducera® AllCeram. The basis for acceptance is rooted in its "nearly equivalent material composition" and "similarity in the formulations" to the predicate device, VITADUR® ALPHA Porcelain (K921623).
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Material composition and formulation similar to legally marketed predicate devices. | "Nearly equivalent material composition of Ducera® AllCeram to the predicate device" and "similarity in the formulations to those legally marketed devices." |
| Components previously used in legally marketed devices. | "All of the components found in Ducera® AllCeram have been used in legally marketed devices." |
| Safety and effectiveness for the intended use (veneering of aluminum oxide cores or tooth preparations). | Supported by 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." (Note: "performance data provided" is not detailed in this summary). |
2. Sample Psize used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a material substantial equivalence submission, not a performance study involving a test set of data/images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for a test set is not relevant to this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a dental material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" used for this submission is the established safety and effectiveness of the predicate device's material composition and components.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this material evaluation.
9. How the ground truth for the training set was established
Not applicable.
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11043247 510(k) SUMMARY
DEC 22 2004
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
1
| 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
:10:
§ 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.