(80 days)
Not Found
No
The summary describes a material (PEEK) used for fabricating dental restorations via CAD/CAM, and the performance studies focus on the physical and biocompatibility properties of the material itself, not on any software or algorithmic capabilities. There is no mention of AI, ML, image processing, or any data sets related to training or testing algorithms.
No.
The device is a material (a solid disc composed of polyether ether ketone) used for the fabrication of permanent dental restorations, not a therapeutic device meant to treat or cure a disease.
No
This device is a material (a solid disc composed of polyether ether ketone or PEEK) used for the fabrication of permanent dental restorations. It is not used to diagnose a medical condition.
No
The device description explicitly states that PEEK Biosolution is a "solid disc composed of polyether ether ketone (PEEK)". This indicates a physical material, not software. The performance studies also focus on the physical properties of this material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of permanent dental restorations using CAD/CAM techniques. This is a manufacturing process for a medical device that will be implanted or used within the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a solid disc of PEEK material used for fabrication. This is a raw material for creating a medical device, not a diagnostic test kit or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on the physical and mechanical properties of the material and the fabricated restorations, as well as biocompatibility.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to provide information about a person's health status, diagnose diseases, or monitor treatment. This device's function is to be shaped into a dental restoration, which is a therapeutic or restorative device.
N/A
Intended Use / Indications for Use
PEEK Biosolution is intended to be used for the fabrication of permanent dental restorations using CAD/CAM techniques. These are:
- Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm2 connector ● cross-section)
- Crown copings and bridge substructures for composite veneering (max. 2 pontics and min. 13 mm2 connector cross-section))
- . Telescopic primary and secondary crowns and frameworks
- . Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide.
Product codes
EBF
Device Description
PEEK Biosolution is a solid disc composed of polyether ether ketone (PEEK) and is indicated for the fabrication of permanent dental restorations using CAD/CAM techniques and equipment. It is available in diameters of 95 mm and thicknesses of 12, 16, 20, 24, 26, 30 mm. It comes in White and A2/B2 shades.
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)
PEEK Biosolution was tested and found to be in compliance with applicable dental materials standards. Tests performed include:
- Material (PEEK)
- Shape (Disc)
- Melting temperature (339 °C)
- Water sorption ( 910 N (limit of testing device))
- Elongation at fracture, load > 7% (no fracture)
PEEK raw material (granules) used in the production of rod stock was tested by the manufacturer according to ISO 10993-1 and USP Class VI and found to be biocompatible. PEEK Biosolution, which is manufactured from the rod stock, was tested and found to not release extractable inorganic substances, and was not cytotoxic. All tests were performed according to GLP requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
breCAM.BioHPP, K152113
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
December 18, 2018
Merz Dental GmbH % Richard Hunter Principal Washington Regulatory Consultants, LLC 5616 Mariola PI NE Albuquerque, Minnesota 87111
Re: K173124
Trade/Device Name: PEEK Biosolution Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: September 28, 2017 Received: September 29, 2017
Dear Richard 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use
510(k) Number (if known): K173124
Device Name: PEEK Biosolution
Indications for Use:
PEEK Biosolution is intended to be used for the fabrication of permanent dental restorations using CAD/CAM techniques. These are:
- Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm2 connector ● cross-section)
- Crown copings and bridge substructures for composite veneering (max. 2 pontics and min. 13 mm2 connector cross-section))
- . Telescopic primary and secondary crowns and frameworks
- . Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(21 CFR Part 801 Subpart D)
(21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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| 510(k) Summary | K173124 | |
|---|---|---|
| PEEK Biosolution | ||
| Date of Summary: | September 28, 2017 | |
| Submitter: | Company Name: | |
| Address: | Merz Dental GmbH | |
| Eetzweg 20 | ||
| Lutjenburg, Germany D-24321 | ||
| Contact Name: | ||
| Telephone No. | ||
| Fax No. | ||
| e-mail: | Dr. Med. Claudia Bobrowski | |
| (011) 43 81/4 03-4 11 | ||
| (011) 43 81/4 09-1 07 | ||
| Claudia.bobrowski@merz-dental.de | ||
| Device Name: | Proprietary name: | |
| Common name: | ||
| Classification reg: | PEEK Biosolution | |
| Dental material | ||
| 21CFR 872.3690 | ||
| Classification name: Material, Tooth Shade, Resin | ||
| Predicate Devices: | breCAM.BioHPP, K152113 |
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Intended Use:
PEEK Biosolution is intended to be used for the fabrication of permanent dental restorations using CAD/CAM techniques. These are:
- . Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm² connector cross-section)
- . Crown copings and bridge substructures for composite veneering (max. 2 pontics and min.13 mm² connector cross-section))
- Telescopic primary and secondary crowns and frameworks
- . Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide.
Technological characteristics and substantial equivalence:
PEEK Biosolution is substantially equivalent to breCAM.BioHPP (K152113). See table below for a comparison of the two devices. Both devices are solid discs composed of polyether ether ketone (PEEK) and both are indicated for the fabrication of permanent dental restorations using CAD/CAM techniques and equipment. They only differ in dimensions.
| Device | PEEK Biosolution | breCAM.BioHPP |
|---|---|---|
| Indications | Milling blank for fabrication of permanent dental restorations using CAD/CAM techniques. | Same |
| Intended Use | •Fully anatomical crowns and bridges | |
| •Crown copings and bridge substructures for composite veneering | ||
| •Telescopic primary and secondary crowns and frameworks | ||
| •Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide. | Same | |
| Material Class | Polyetheretherketone (PEEK) | Same |
| Material Form | Solid Disc with circumferential ridge | Same |
| Material Comp | PEEK plus pigments | Same |
| Disc Sizes | ||
| Diameter | 95 mm | 84, 95 and 98.5 mm |
| Thickness | 12, 16, 20, 24, 26, 30 mm | 12 to 25 mm |
| Disc Shades | White and A2/B2 | Standard and Dentin |
| Fabrication | Milling | Same |
| Milling | ||
| Equipment | imes-icor, Wieland Dental, Organical, Zirkonzahn or equivalent | Same |
| CAD/CAM | ||
| Software | Software and milling equipment operated by independent dental laboratories | Same |
| Clearance | Subject of Application | K152113 |
| Manufacturer | Merz Dental, GmbH | Bredent GmbH & Co.KG |
Comparison of PEEK Biosolution to breCAM.BioHPP
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PEEK Biosolution was tested and found to be in compliance with applicable dental materials standards. The results and a comparison to the predicate device, breCAM.BioHPP, are presented below.
| Testing
(passing value) | PEEK
BioSolution | breCAM BioHPP | PEEK
Biosolution
Standard |
|----------------------------------------------------------------------|--------------------------------------|-----------------|---------------------------------|
| Material | PEEK | PEEK | NA |
| Shape | Disc | Disc | NA |
| Melting temperature | 339 °C | appr. 340 °C | ISO 11357 |
| Water sorption | 150 MPa) | 178 ± 4 MPa | 174 - 182 MPa | ISO 10477 |
| Flexural strength
after thermocycling, (>150MPa) | 171 ± 5 MPa | 173 - 174 MPa | ISO 10477 |
| Elongation at fracture, (no fracture) | no fracture | no fracture | ISO 10477 |
| Fracture load 3-unit bridge, > 800 N | > 910 N (limit of
testing device) | 1307 N | ISO 10477 |
| Elongation at fracture, load > 7%,
no fracture | no fracture | no fracture | ISO 10477 |
Physical Properties of PEEK Biosolution and breCAM.BioHPP
PEEK raw material (granules) used in the production of rod stock was tested by the manufacturer according to ISO 10993-1 and USP Class VI and found to be biocompatible. PEEK Biosolution, which is manufactured from the rod stock, was tested and found to not release extractable inorganic substances, and was not cytotoxic. All tests were performed according to GLP requirements.
Summary:
Based on the above description of the Merz Dental GmbH PEEK Biosolution and the predicate device. Merz Dental considers PEEK Biosolution to be substantially equivalent to the cited predicate device, and safe and effective for its intended use.