(41 days)
ZENO® Al cco Discs are milling blanks from which single copings and primary components for anteriors and premolars can be made. These are intended for use as ceramic frameworks for dental prosthetics.
ZENO Al eco Discs are milling blanks composed of pure aluminium oxide. They are intended to be used by professional dental technicians for making single copings and primary components for anteriors and premolars to apply them as ceramic frameworks for dental prosthetics for the sole use of particular patients. ZENO Al eco Discs can be machined in all machines of the ZENO Tec system. The manufacturing process of this ceramic framework consists of different steps. At first the model has to be scanned. In the next step, the restoration has to be designed virtually with the help of the CAD technology. Thereafter, the realization of this design has to be carried out by the CAM technology. In a final step after hard sintering of the ZENO Al eco, the framework can be veneered with a suitable veneering ceramic.
This document is a 510(k) summary for the ZENO Al eco Disc, a dental milling blank. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial with acceptance criteria for a new AI/software device. Therefore, many of the requested categories related to AI performance studies are not applicable or cannot be extracted from this document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or device performance data in the way an AI/software device submission would. Instead, it relies on demonstrating equivalence to a predicate device based on material properties and intended use.
| Acceptance Criteria (Not explicitly stated for a new AI device, but implied for equivalence) | Reported Device Performance (as stated for equivalence) |
|---|---|
| Material Composition Equivalence | Both ZENO Al eco Discs and the predicate (inCoris AL) are based on Aluminum oxide. |
| Indications for Use Equivalence | Both have similar indications for use. |
| Physical, Biological, and Chemical Properties Equivalence | Both have comparable physical, biological, and chemical properties. |
| Safety and Effectiveness Equivalence | ZENO Al eco Discs possess "high-level safety and effectiveness" due to excellent material properties; performs "as well as or better than the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
N/A. This is a material-based dental device, not an AI/software device requiring a test set of data for performance evaluation. The submission relies on laboratory testing of material properties, not a "test set" of patient data.
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)
N/A. Not applicable to this type of device submission. Ground truth, in the context of AI, involves expert-level annotations or diagnoses, which is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not applicable to this type of device submission.
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
N/A. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a material-based device like this, "ground truth" typically refers to established standards for material properties (e.g., strength, biocompatibility) as assessed through standardized laboratory tests. The document implies that these properties were tested and found to be comparable to the predicate device, but specific details of these tests are not provided in the summary.
8. The sample size for the training set
N/A. This is not an AI/machine learning device. The "training" for such a device would involve optimizing the manufacturing process to achieve desired material properties, not training an algorithm on a dataset.
9. How the ground truth for the training set was established
N/A. Not applicable to this type of device submission.
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Image /page/0/Picture/1 description: The image shows the word "WIELAND" in a bold, sans-serif font. The letters are black and appear to have a slightly rough or textured edge, giving them a somewhat distressed look. The word is presented in all capital letters and is horizontally oriented.
WIELAND Dental | Technik GmbH & Co. KG Schwenninger Straße 13 75179 Pforzheim, Germany Postlad: 10 20 40 /5120 Pforzheim, Germany Fon +49 72 31/ 37 05 - 0 Fax +49 77 317 35 79 59
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SEP 1 8 2008
7. 510 (k) Summary
Wieland Dental + Technik GmbH & Co. KG Submitter of 510(k): Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0
| Contact person: | Dr. Gerhard Polzer |
|---|---|
| Phone: | +49-7231-3705-219 |
| Fax: | +49-7231-357959 |
| e-mail: | gerhard.polzer@wieland-dental.de |
Date of Summary: 2008-07-03
Trade name:
ZENO Al eco Disc
Classification name: Powder, Porcelain Product code: ElH C.D.R section: 872.6660 Classification: Class II
Legally marketed equivalent device: inCoris AL
510(k) number: K062506
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WIFLAND Dental + Technik Gmbll & Co. KG Schwenninger Straße 13 75179 Plorzheim, Germany Postfach 10 20 40 75120 Pforzheim, Germany Fort +49 /2 31/ 37 05 - 0 Fax +49 /2 31/ 35 79 59
510 (k) Summary
Device description
ZENO Al eco Discs are milling blanks composed of pure aluminium oxide. They are intended to be used by professional dental technicians for making single copings and primary components for anteriors and premolars to apply them as ceramic frameworks for dental prosthetics for the sole use of particular patients.
ZENO Al eco Discs can be machined in all machines of the ZENO Tec system. The manufacturing process of this ceramic framework consists of different steps. At first the model has to be scanned. In the next step, the restoration has to be designed virtually with the help of the CAD technology. Thereafter, the realization of this design has to be carried out by the CAM technology. In a final step after hard sintering of the ZENO Al eco, the framework can be veneered with a suitable veneering ceramic.
Recommended application
With the introduction of the ZENO AI eco Discs, Wieland Dental+Technik offers to the customer for the ZENO TEC System the possibility to produce high aesthetic single copings and primary components on the base of Aluminium oxide. This kind of restoration is cost- and time saving and the restorations have excellent properties.
Comparison with the predicate device
- ZENO Al eco Discs are substantially equivalent to the dental device inCoris AL. Both devices based on Aluminium oxide and have similar indications for use and comparable physical, biological, and chemical properties.
Due to the excellent material properties of the ZENO AI eco Discs, the restorations possess a high-level safety and effectiveness. ZENO AI eco Discs therefore are as safe, as effective, and performs as well as or better than the predicate device.
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SEP 1 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Company KG Schwenninger Straße 13 75179 Pforzheim, Germany
Re: K082257
Trade/Device Name: ZENO AI cco Disc Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 4, 2008 Received: August 8, 2008
Dear Dr. Polzer:
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 - Dr. Polzcr
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu S. Lin, Ph. D
Division 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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WILLAND Dental + Technik GmbH & Co. KG Schwenninger Straße 13 15179 Pforzheim, Germany Postfach 10 20 40 75120 Pforzheim, Germany Fon +49 72 31/ 37 05 - 0
Fax +49 72 311 35 79 59
12.8. Indication for use statement
Indications for Use
510(k) Number (if known): KO82257
Device Name: ZENO Al eco Disc
Indications for Use:
ZENO® Al cco Discs are milling blanks from which single copings and primary components for anteriors and premolars can be made.
These are intended for use as ceramic frameworks for dental prosthetics ..
Prescription Use (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K01
Page 1 of 1
(Posted November 13, 2003)
§ 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.