(74 days)
ZENO®PMMA Discs are milling blanks consisting of polymethylmethacrylate. They are designed for making long-term temporary crown and bridge work and have to be machined with the CAD/CAM technique. ZENO PMMA Discs are recommended for manufacturing substructures of single tooth and bridgework with one or two pontics.
ZENO PMMA Discs (A3/B1) are milling blanks composed of hot cured polymethylmethacrylate (PMMA). They are intended to be used by professional dental technicians for making long-term temporary crowns and bridgeworks for the sole use of particular patients.
ZENO PMMA Discs can be machined in all machines of the ZENO Tec system. The manufacturing process of the long-term temporary crowns and bridges 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 the restoration can be individually characterised with dental veneering composites for improving the aesthetics and it can be pre- and high shine polished.
The ZENO PMMA Discs are offered in two different shades (A3, B1) and thicknesses.
The provided document is a 510(k) summary for a dental device (ZENO PMMA Disc). It does not contain information about acceptance criteria for device performance, nor does it describe a study proving the device meets specific performance criteria.
Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device (VITA CAD-TEMP). This is a different regulatory pathway than providing detailed performance studies against defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document. However, I can provide what information is available based on the request:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable: The document does not provide specific acceptance criteria or performance data for the ZENO PMMA Disc. It asserts "comparable physical, biological, and chemical properties" to the predicate device but does not quantify these or establish specific criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable: No clinical or laboratory performance study against specific criteria is described, so no test set sample size or data provenance is mentioned.
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: No ground truth establishment activity for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No adjudication for a test set is described.
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 is a material science device, not an AI or imaging device, so an MRMC study is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a material science device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable: No ground truth used for performance evaluation is described. The "ground truth" for regulatory submission in this case is the predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Not Applicable: This is a material science device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable: As above, no training set or ground truth for it is relevant or mentioned.
Summary of available information related to equivalence, as described in the document:
The regulatory submission asserts substantial equivalence based on:
- Identical indication for use: ZENO PMMA Discs and the predicate (VITA CAD-TEMP) are both used for making long-term temporary crowns and bridgeworks.
- Comparable material properties: Both devices are acrylate polymers and "have comparable physical, biological, and chemical properties." (No specific data provided in this summary to quantify "comparable").
- Similar function: Both devices have the "same prophylactic, diagnostic and aesthetic function."
The document states: "Due to the high polymerization grade and excellent material properties of the ZENO PMMA Discs, the restorations possess a high-level safety and effectiveness. ZENO PMMA Discs therefore are as safe, as effective, and performs as well as or better than the predicate device." This is the core argument for substantial equivalence rather than a detailed performance study against acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the word "WIELAND" in large, bold, black letters. The letters are sans-serif and appear to be slightly distressed or textured, giving them a somewhat rough appearance. The word is horizontally oriented and fills most of the frame.
GmbH & Co. KG Schwenninger Straße 13 75179 Pforzheim, Germany Postfach 10 20 40 75120 Pforzheim, Germany Fon +49 72 31/ 37 05 0 lax +49 /2 31/ 35 79 59
WIELAND Dental + Technik
510 (k) Summary 5.
APR - 8 2008
Submitter of 510(k): Wieland Dental + Technik GmbH & Co. KG 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: 2008-01-07
Trade name:
ZENO PMMA DISC
Classification name: Temporary crown and bridge resin Product code: EBG C.D.R section: 872.3770 Classification: Class II
| Legally marketedequivalent device: | VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4004 |
|---|---|
| 510(k) number: | K 070991 |
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Image /page/1/Picture/0 description: The image shows the word "WIELAND" in large, bold, black letters against a white background. The font appears to be sans-serif, and the letters are slightly distressed, giving them a textured look. The word is horizontally oriented and fills most of the frame.
WIFLAND Dental + Technik GmbH & Co KG Schwenninger Straße 13 75179 Pforzheim. Germany Postfach 10 20 40 75120 Pforzheim, Germany Fan +49 72 31/ 37 05 - 0 Fax +49 72 31/35 79 59
510 (k) Summarv
Device description
ZENO PMMA Discs (A3/B1) are milling blanks composed of hot cured polymethylmethacrylate (PMMA). They are intended to be used by professional dental technicians for making long-term temporary crowns and bridgeworks for the sole use of particular patients.
ZENO PMMA Discs can be machined in all machines of the ZENO Tec system. The manufacturing process of the long-term temporary crowns and bridges 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 the restoration can be individually characterised with dental veneering composites for improving the aesthetics and it can be pre- and high shine polished.
The ZENO PMMA Discs are offered in two different shades (A3, B1) and thicknesses.
Recommended application
With the introduction of the ZENO PMMA Discs, Wieland Dental+Technik offers to the customer for the ZENO TEC System the possibility of producing long-term temporary crowns and bridgeworks with one or two pontics. These could be used, for example, with patients who should receive an implant -supported restoration, in which the long-term temporary restoration has a prophylactic function to prevent any change of the position of the abutment-teeth. In addition, the teeth are protected by the restoration against the influence of bacterial, toxic as well as thermal effects. Furthermore, it becomes possible to check the occlusion, the phonetics as well as the aesthetics.
Comparison with the predicate device
ZENO PMMA Discs are substantially equivalent to the dental device VITA CAD-TEMP. Both devices are acrylate polymers and have identical indication for use, comparable physical, biological, and chemical properties and the same prophylactic, diagnostic and aesthetic function.
Due to the high polymerization grade and excellent material properties of the ZENO PMMA Discs, the restorations possess a high-level safety and effectiveness. ZENO PMMA Discs therefore are as safe, as effective, and performs as well as or better than the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 2008
Gerhard Polzer, Ph.D. Director Regulatory Affairs Wieland Dental + Technik GmbH & Company KG Schwenninger Straße 13 D-75179 Pforzheim, GERMANY
Re: K080182
Trade/Device Name: ZENO PMMA Disc Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: January 18, 2008 Received: January 25, 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 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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syltte y. Michau Oms.
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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Image /page/4/Picture/0 description: The image shows the word "WIELAND" in a bold, sans-serif font. The letters are black and have a slightly distressed or textured appearance, as if they have been stamped or printed with a slightly uneven distribution of ink. The word is presented in all capital letters and is horizontally oriented.
WIELAND Dental + Technik GmbH & Co. KG Schwenninger Straße 13 75179 Pforzheim, Germany Postfach 10 20 40 75120 Pforzheim, Germany lion +49 7231/37 05-0 Fax +49 72 31/ 35 79 59
Indication for use statement 11.8.
Indications for Use
| 510(k) Number (if known): | K060182 |
|---|---|
| --------------------------- | --------- |
Device Name: ZENO PMMA Disc
Indications for Use:
ZENO®PMMA Discs are milling blanks consisting of polymethylmethacrylate. They are designed for making long-term temporary crown and bridge work and have to be machined with the CAD/CAM technique. ZENO PMMA Discs are recommended for manufacturing substructures of single tooth and bridgework with one or two pontics.
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)
Swati Kumar
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080182 and here is the code to generate that json:```json {
(Posted November 13, 2003)
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.