(76 days)
Not Found
No
The device is a milling blank made of PMMA, and the description focuses on its physical properties and intended use in fabrication, with no mention of AI or ML.
No
The device is a material (PMMA discs) used for fabricating temporary dental restorations, not a therapeutic device that directly treats a condition. Its use is in the creation of a temporary prosthetic.
No
Explanation: The device is a material (PMMA discs) used to fabricate provisional dental restorations, not to diagnose a condition. Its intended use is fabrication, and the performance studies mention compliance to material standards, not diagnostic metrics.
No
The device description clearly states it is "Discs of PMMA," which are physical materials, not software. The intended use also describes a physical milling blank.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use as a milling blank in the fabrication of provisional crowns and bridges." This describes a material used in a dental fabrication process, not a test performed on a biological sample to diagnose a condition.
- Device Description: The device is described as "Discs of PMMA... for milling into provisional crowns and bridges." This further reinforces its role as a material for dental prosthetics.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
The device is a material used in a dental laboratory or clinic setting to create temporary dental restorations. This falls under the category of a dental material or prosthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use as a milling blank in the fabrication of provisional crowns and bridges.
Product codes
EBG
Device Description
Discs of PMMA in two sizes and three shades for milling into provisional crowns and bridges
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
Not Found
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)
Tested for compliance to ISO 3336 and ISO 10993
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Premarket Notification Temporary Crown and Bridge Material
:
:
Merz Dental GmbH Lütjenburg, Germany
VIII. Premarket Notification 510(k) Summary
| Submitted by: | Merz Dental GmbH
Eetzweg 20
D-24321 Lutjenburg
Germany
0 43 81/4 03-4 11 (phone)
0 43 81/4 09-1 07 (fax)
AUG 2 1 2007 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dr. Med Claudia Bobrowski |
| Date prepared: | June 1, 2007 |
| Device proprietary name: | Wieland Zeno CAO temporary PMMA disc,
tooth-colored |
| Common name: | PMMA Crown and Bridge Material |
| Classification name: | Temporary Crown and Bridge Resin
(21 CFR 872.3770) |
| Predicate devices: | artegral® ImCrown,
Merz Dental (K061809)
Temporary Crown and Bridge Material,
Dentsply International (K060293) |
| Description of the device: | Discs of PMMA in two sizes and three shades
for milling into provisional crowns and bridges |
| Intended use: | For use as a milling blank in the fabrication of
provisional crowns and bridges. |
| Characteristics: | An ideal material for the fabrication of
provisional crowns and bridges because of its
strength, ease of milling, dimensional stability,
and natural esthetic. |
| Testing:
10993 | Tested for compliance to ISO 3336 and ISO |
1
Image /page/1/Picture/11 description: The image shows a circular seal or logo. The text around the top of the circle reads "HUMAN SERVICES - USA". The text around the bottom of the circle reads "DEPARTMENT OF HEALTH & ". Inside the circle is a stylized graphic, possibly representing a flag or a symbol of the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2007
Merz Dental GmbH C/O Mr. Richard G. Hunter Principal Washington Regulatory Consultants 5616 Mariola Place, NE Albuquerque, New Mexico 87111
Re: K071548
Trade/Device Name: Wieland Zeno CAO Temporary PMMA Disc, Tooth-Colored Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: August 3, 2007 Received: August 13, 2007
Dear Mr. Hunter:
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.
2
Page 2 - Mr. Hunter
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,
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
3
Merz Dental GmbH Lütjenburg, Germany
V. Indications for Use Statement
510(k) Number: To be assigned K071548
Device Name:
Wieland Zeno CAO temporary PMMA disc, tooth-colored
Indications for Use:
For use as a milling blank in the fabrication of provisional crowns and bridges.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart ) ________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susar Runne | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K071548 |
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