(80 days)
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.
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.
The provided text describes the regulatory filing for the PEEK Biosolution dental material, which is a Class II medical device. The information details the device's characteristics, intended use, and a comparison to a predicate device (breCAM.BioHPP) to establish substantial equivalence.
Here's an analysis of the provided text in relation to your request for acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The provided document includes a table titled "Physical Properties of PEEK Biosolution and breCAM.BioHPP" which clearly lists various physical and mechanical properties. The "passing value" serves as the acceptance criteria for most of these tests.
| Testing (passing value) | Acceptance Criteria (Passing Value) | Reported PEEK BioSolution Performance | breCAM BioHPP Performance | PEEK Biosolution Standard |
|---|---|---|---|---|
| Material | Preek | PEEK | PEEK | NA |
| Shape | Disc | Disc | Disc | NA |
| Melting temperature | Not explicitly stated | 339 °C | appr. 340 °C | ISO 11357 |
| Water sorption | Not explicitly stated | < 7.6 µg / mm3 | 6.5 µg / mm3 | ISO 62 |
| Bond strength to veneering resins after thermo cycling | ≥ 15MPa | 22 MPa | 21.4 MPa | ISO 10477 |
| Density | Not explicitly stated | 1.49 ± 0.03 | 1.4425 g/cm3 | ISO 1183 |
| Modulus of elasticity | Not explicitly stated | 5100 ± 210 MPa | 4550 - 4620 MPa | ISO 20795-1 |
| Flexural strength | >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 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each of the physical and mechanical tests. It also does not directly state the data provenance in terms of country of origin or whether the studies were retrospective or prospective. It only mentions that "All tests were performed according to GLP requirements," which implies a certain standard of research practice but not the specific design or origin.
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)
This information is not applicable to this type of device and study. The testing for the PEEK Biosolution material is based on standardized physical and mechanical property measurements, not on expert interpretation of medical images or clinical outcomes that would require a "ground truth" established by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints, where disagreements between evaluators need to be resolved. The tests performed for this device are objective measurements of material properties.
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
An MRMC comparative effectiveness study is not applicable to this device. This type of study assesses the performance of diagnostic devices, especially those involving human interpretation, and often in the context of AI assistance. PEEK Biosolution is a dental material, not a diagnostic tool or an AI-powered system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to the PEEK Biosolution device as it is a physical dental material, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical and mechanical testing: The "ground truth" in this context refers to the established scientific and engineering principles and the measurement methods defined by international standards (e.g., ISO 11357, ISO 62, ISO 10477, ISO 1183, ISO 20795-1). The device's performance is compared against these predetermined criteria as defined by the standards and often to the predicate device's measured performance.
For biocompatibility: The ground truth was established by recognized standards like ISO 10993-1 and USP Class VI, which define the acceptable biological response of materials in contact with the body.
8. The sample size for the training set
This is not applicable as PEEK Biosolution is a physical dental material and does not involve AI or machine learning models that require training sets.
9. How the ground truth for the training set was established
This is not applicable for the same reason as #8.
{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);
{1}------------------------------------------------
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
{2}------------------------------------------------
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 ____________________________________________________________________________________________________________________________________________________________________
{3}------------------------------------------------
| 510(k) Summary | K173124 | |
|---|---|---|
| PEEK Biosolution | ||
| Date of Summary: | September 28, 2017 | |
| Submitter: | Company Name:Address: | Merz Dental GmbHEetzweg 20Lutjenburg, 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 07Claudia.bobrowski@merz-dental.de | |
| Device Name: | Proprietary name:Common name:Classification reg: | PEEK BiosolutionDental material21CFR 872.3690Classification name: Material, Tooth Shade, Resin |
| Predicate Devices: | breCAM.BioHPP, K152113 |
{4}------------------------------------------------
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 |
| MillingEquipment | imes-icor, Wieland Dental, Organical, Zirkonzahn or equivalent | Same |
| CAD/CAMSoftware | 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
{5}------------------------------------------------
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) | PEEKBioSolution | breCAM BioHPP | PEEKBiosolutionStandard |
|---|---|---|---|
| Material | PEEK | PEEK | NA |
| Shape | Disc | Disc | NA |
| Melting temperature | 339 °C | appr. 340 °C | ISO 11357 |
| Water sorption | < 7.6 µg / mm3 | 6.5 µg / mm3 | ISO 62 |
| Bond strength to veneering resinsafter thermo cycling, (≥ 15MPa) | 22 Mpa | 21.4 MPa | ISO 10477 |
| Density | 1.49 ± 0.03 | 1.4425 g/cm3 | ISO 1183 |
| Modulus of elasticity | 5100 ± 210 MPa | 4550 - 4620 MPa | ISO 20795-1 |
| Flexural strength, (>150 MPa) | 178 ± 4 MPa | 174 - 182 MPa | ISO 10477 |
| Flexural strengthafter 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 oftesting 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.
§ 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.