(306 days)
- Definitive supported and veneered crowns and bridges with maximum two pontics. Can be veneered with bonded press crowns, with composites or prefabricated acrylic teeth and veneers.
- Definitive supported, veneered single crowns and bridges with maximum one pontic on natural teeth.
- Removable restoration such as secondary structures on bars and telescopic crowns, transversal connectors, occlusal splints and denture bases.
Pekkton® Ivory is a semi-crystalline thermoplastic supplied in milling blanks and press blanks. By application of CAD/CAM milling or pressing technology according to the instructions for use, it can be used by the dental technician to manufacture permanent crowns, bridges and denture frameworks.
This document is a 510(k) premarket notification for a dental material called Pekkton® Ivory. It does not describe an AI/ML powered device, but rather a physical dental product. Therefore, the information requested about acceptance criteria and study proving the device meets the criteria, particularly regarding AI/ML specifics like MRMC studies, training/test sets, and expert adjudication, is not applicable to this document.
The document discusses the substantial equivalence of Pekkton® Ivory to a predicate device (BioHPP-breCAM.BioHPP) and a reference device (Pekkton® Ivory K123638). The "studies" mentioned are primarily non-clinical tests to assess biological, chemical, and physical properties of the material.
Here's an analysis of what is provided, framed as closely as possible to your request, but acknowledging the difference in device type:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparative table of technological characteristics between the predicate device (BioHPP-breCAM.BioHPP) and Pekkton® Ivory, along with relevant standards. These values serve as the "performance" data, and the comparison to the predicate and relevant ISO standards imply the "acceptance criteria."
| Characteristic | Predicate Device (BioHPP-breCAM.BioHPP) | Pekkton® Ivory (Candidate) | Remarks / Implied Acceptance Criteria |
|---|---|---|---|
| Device Name | BioHPP- breCAM.BioHPP | Pekkton® Ivory | Comparable device type |
| 510(k) No | K152113 | K170102 | (Not a performance metric) |
| Classification Name | Tooth shade resin material | Tooth shade resin material | Same classification name |
| Product Code | EBF | EBF | Same code |
| Regulation Number | 872.3690 | 872.3690 | Same regulation |
| Intended Use | Fabrication of definitive crown and bridge frameworks with no more than 2 pontics and for definitive removable restorations. | Intended for use with fixed (crowns and bridges) and removable dental prostheses. | Comparable intended use |
| Material | PEEK (Polyetheretherketone) | PEKK (Polyetherketoneketone) Titanium Dioxide | Both are Poly-aryl-ether-ketones (PAEK), considered comparable. |
| Form | Granulate-Pellets, Disc | Press blanks, Milling blanks | Comparable forms |
| Processing | Melt processing of thermoplastic (Heat and pressure) | CAD/CAM Milling, Melt processing of thermoplastic (Heat and pressure) | Comparable processing |
| Melting Temperature | approx. 340°C | Approx. 363 °C | Comparable temperature |
| Bond strength to veneering resins | 25.2 MPa | > 15 MPa | Standard ISO EN 10477:2004 requires 5 MPa. Pekkton® Ivory exceeds this. |
| E-Modulus | approx. 4083 – 4630 MPa | approx. 5000 MPa | Compared against ASTM-D638. Value is within a comparable range. |
| Flexural strength | 163 – 179 MPa | 200 MPa | Compared against ASTM-D790. Value is within a comparable range. |
| Water absorption | 6.5 ug/mm3 | 8.7 ug/mm3 | Standard ISO 4049-2009 requires water sorption lower than 40 ug/mm3. Pekkton® Ivory meets this. |
| Water solubility | 0.1 ug/mm3 | 0.2 ug/mm3 | Standard ISO 4049-2009 requires water solubility lower than 7.5 ug/mm3. Pekkton® Ivory meets this. |
Acceptance Criteria Statement: The document explicitly states: "Testing has shown that Pekkton® Ivory is equivalent in performance characteristics to the predicate device BioHPP. The acceptance criteria were met."
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each physical/chemical test (e.g., how many specimens were tested for flexural strength). It refers to "non-clinical test data."
- Data Provenance: The tests were conducted according to international standards (ISO, USP, ASTM). The country of origin of the data is implied to be Switzerland, where CENDRES+METAUX SA is based. The data is "retrospective" in the sense that the testing was completed prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" for a physical dental material is established through objective, standardized physical and chemical tests, not through expert consensus on interpretations like medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective assessments, typically in image interpretation or clinical outcomes, not for objective material property testing.
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 for a physical dental material, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on objective, quantitative measurements of physical and chemical properties (e.g., melting temperature, bond strength, flexural strength, water absorption/solubility) derived from adherence to established international standards (ISO, ASTM, USP).
- For biological risks, the "ground truth" or assessment of safety is based on biocompatibility testing against recognized standards (ISO 10993 series and ISO 7405).
8. The sample size for the training set:
- Not applicable. There is no concept of a "training set" for physical material properties in this context, as there is no machine learning model involved. The manufacturing process and material formulation are "trained" through R&D and quality control, but not in the AI/ML sense.
9. How the ground truth for the training set was established:
- Not applicable. See point 8. The "ground truth" for the material's properties is established through the test methods and standards mentioned in point 7.
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November 13, 2017
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
CENDRES+METAUX SA Uli DIERMANN Head of Regulatory Affairs Rue De Bouiean 122 CH-2501 Biel/Bienne Switzerland
Re: K170102
Trade/Device Name: Pekkton Ivory Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, POW Dated: September 21, 2017 Received: September 27, 2017
Dear Uli DIERMANN:
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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Page 2 - Uli DIERMANN
1000-1050.
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
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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Indications for Use
510(k) Number (if known) K170102
Device Name
Pekkton® Ivory
Indications for Use (Describe)
- · Definitive supported and veneered crowns and bridges with maximum two pontics. Can be veneered with bonded press crowns, with composites or prefabricated acrylic teeth and veneers.
- · Definitive supported, veneered single crowns and bridges with maximum one pontic on natural teeth.
- · Removable restoration such as secondary structures on bars and telescopic crowns, transversal connectors, occlusal splints and denture bases.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows a logo for a company called "Cendres+ Metaux". The logo consists of a stylized letter "C" on the left, followed by the company name in a simple, sans-serif font. The word "Cendres" is above the word "Metaux", with a plus sign after "Cendres". The logo is black and white.
510(k) Summary: Pekkton® lvory (K170102)
| 510(k) Owner | CENDRES+METAUX SARue de Boujean 122CH-2501 Biel / BiennePhone : +41 58 360 20 00Fax : +41 58 360 20 10 |
|---|---|
| Contact person | Uli Diermann (uli.diermann@cmsa.ch) |
| Date of Preparation | 09 November 2017 |
| Trade Name | Pekkton® Ivory |
| Common Name | dental material, milling blank, press blank |
| Classification Name | Tooth shade resin material |
| Classification | Class II |
| Product Code | EBF |
| Regulation Number | 872.3690 |
Primary predicate device, legally marketed device to which substantially equivalence is claimed
| Primary predicate device | 510(k) Number | 510(k) Holder |
|---|---|---|
| BioHPP- breCAM.BioHPP | K152113 | Bredent Gmbh & Co.KG |
| Reference device | 510(k) Number | 510(k) Holder |
| Pekkton® Ivory | K123638 | CENDRES+METAUX SA |
Description of the device
Pekkton® Ivory is a semi-crystalline thermoplastic supplied in milling blanks and press blanks. By application of CAD/CAM milling or pressing technology according to the instructions for use, it can be used by the dental technician to manufacture permanent crowns, bridges and denture frameworks.
Indication for Use of the device
- . Definitive supported and veneered crowns and bridges with maximum two pontics. Can be veneered with bonded press crowns, with composites or prefabricated acrylic teeth and veneers.
- Definitive supported, veneered single crowns and bridges with maximum one pontic on natural . teeth.
- . Removable restoration such as secondary structures on bars and telescopic crowns, transversal connectors, occlusal splints and denture bases.
Summary Technological Characteristics
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Image /page/4/Picture/1 description: The image shows the logo for Cendres+Metaux. The logo consists of a stylized letter "C" on the left, followed by the text "CENDRES+" on the first line and "MÉTAUX" on the second line. The text is in a simple, sans-serif font, and the entire logo is in black and white.
The proposed Pekkton® Ivory is substantially equivalent to the predicate device. The difference between Pekkton® Ivory and the predicate device BioHPP is not significant. Any differences do not affect the safety and effectiveness of the device when used as labeled.
| Substantial equivalence comparison to the predicate device | |
|---|---|
| Predicate Device | Candidate | Remarks | ||
|---|---|---|---|---|
| Device Name | BioHPP- breCAM.BioHPP | Pekkton® Ivory | ||
| 510(k) No | K152113 | K170102 | ||
| Classification Name | Tooth shade resin material | Tooth shade resin material | Same classification name | |
| Product Code | EBF | EBF | Same code | |
| Regulation Number | 872.3690 | 872.3690 | Same regulation | |
| Intended Use | BioHPP high-performance polymer is used for the fabrication of definitive crown and bridge frameworks with no more than 2 pontics and for definitive removable restorations. | Pekkton® Ivory is intended for use with fixed (crowns and bridges) and removable dental prostheses. | Comparable intended use | |
| Indications for use | BioHPPbreCAM.BioHPPBioHPP high-performance polymer is used for the fabrication of definitive crown and bridge frameworks with no more than 2 pontics and for definitive removable restorations. BioHPP can also be used for fully anatomical pressed bridge structures - with or without buccal composite veneering.Crown copings and bridge substructures for composite veneers (max. 2 pontics)Fully anatomical crowns and bridges (max. 2 pontics) | Pekkton® IvoryDefinitive supported, veneered and screw-retained crowns and bridges on dental implants, with maximum two pontics. Can be veneered with bonded press crowns, with composites or prefabricated acrylic teeth and veneers. | In general the indications are comparable, but the wording is different. The Pekkton® indications focus on the application for maximum 2 pontics. But bridge structures and buccal composite veneering is covered in the indications. The indications of BioHPP do not differentiate between natural teeth and implants. For Pekkton® the indication differentiate between both. Pekkton® is indicated only for removable restorations. It an be can be used for all standard materials The differences do not have impact on safety and effectiveness of the device Pekkton® Ivory. | |
| breCAM.BioHPP is used for the fabrication of permanent restorations using CAD/CAM techniques.Crown copings and bridge substructures for composite veneering (max. 2 pontics and min.13 mm² connector cross-section))Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm² connector crosssection) | Definitive supported, veneered single crowns and bridges with maximum one pontic on natural teeth. | |||
| Telescopic primary and secondary crowns and frameworksSecondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide | Removable restorations such as secondary constructions on bars and telescopic crowns, transversal connectors, occlusal splints and denture bases. | |||
| Predicate Device | Candidate | Remarks | ||
| BioHPP- breCAM.BioHPP | Pekkton® Ivory | |||
| Material | : | PEEK(Plyetheretherketone) | PEKK(Polyetherketoneketone)Titanium Dioxide | PEEK and PEKK belong both to the family of poly-aryl-ether-ketones (PAEK). |
| Form | : | Granulate-PelletsDisc | Press blanksMilling blanks | Comparable forms |
| Processing | : | Melt processing of thermoplastic(Heat and pressure) | CAD/CAM MillingMelt processing of thermoplastic(Heat and pressure)CAD/CAM Milling | Comparable processing |
| Meltingtemperature | : | approx. 340°C | Approx. 363 °C | Comparable temperature |
| Bondstrength toveneeringresins | : | 25.2 MPa | > 15 MPa | Standard ISO EN 10477:2004 requires 5 MPa |
| E-Modulus | : | approx. 4083 – 4630 MPa | approx. 5000 MPa | ASTM-D638 |
| Flexuralstrength | : | 163 – 179 MPa | 200 MPa | ASTM-D790 |
| Waterabsorption | : | 6.5 ug/mm3 | 8.7 ug/mm3 | Standard ISO 4049-2009 requires water sorption lower than 40 ug/mm3 |
| Watersolubility | : | 0.1 ug/mm3 | 0.2 ug/mm3 | Standard ISO 4049-2009 requires water solubility lower than 7.5 ug/mm3 |
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Image /page/5/Picture/0 description: The image shows the logo for Cendres+Metaux. The logo consists of a stylized "CM" on the left, followed by the text "CENDRES+" on the top line and "MÉTAUX" on the bottom line. The text is in a simple, sans-serif font and is all in black.
Table 5-1
We conclude that for all significant parameters Pekkton® Ivory is substantially equivalent to its above mentioned predicate device BioHPP- breCAM.BioHPP.
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Image /page/6/Picture/1 description: The image shows the logo for Cendres+Metaux. The logo consists of a stylized letter "C" on the left, followed by the text "CENDRES+" on the top line and "MÉTAUX" on the bottom line. The letter "C" is thick and black, while the text is in a simple, sans-serif font, also in black.
Summary of Testing to Demonstrate Substantial Equivalence / Conclusion:
For the risk assessment of biological risks, the procedures and provisions of ISO 10993-1:2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", recognition number 2-156, were applied. Based upon the criteria set out in this standard, the product is biologically classified as an "external communicating device" with "permanent" (> 30 days) contact to "tissue, bone or dentine".
In accordance with the aforementioned standards, in accordance with ISO 7405:2008 Dentistry evaluation of biocompatibility of medical devices used in dentistry including: amendment 1 (2013), recognition number 4-212 and in accordance with "510(k) Memorandum - #G95-1 Attachment B – Table 2 Supplementary Evaluation Tests for Consideration", the following test methods were particularly considered, conducted and passed the criteria:
| Test methods | Standard | Recognition Number |
|---|---|---|
| Cytotoxicity | ISO 10993-5:2009 | 2-153 |
| Irritation | ISO 10993-10:2010 | 2-174 |
| Delayed-type hypersensitivity | ISO 10993-10:2010 | 2-174 |
| Systemic Toxicity | ISO 10993-11:2006 | 2-176 |
| Subchronic and chronicsystemictoxicity | ISO 10993-11:2006 | 2-176 |
| Implantation | ISO 10993-6:2007 | 2-177 |
| Genotoxicity | ISO 10993-3:2014 | 2-228 |
| Chemical characterization | ISO 10993-18:2009 | - |
| USP Plastic Class VI | USP 34 (88) | - |
Table 5-2
The subject device Pekkton® Ivory (K170102 ) is identical to the reference device Pekkton® Ivory (K123638). No incidents or adverse events have been reported since the market launch of Pekkton® lvory (K123638).
Non-clinical test data was used to support the substantially equivalence claim. Non-clinical testing consisted of analysis of devices to identify worst-case test samples. The evaluation was based on FDA guidance "Guidance for Industry and FDA Staff, Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions."
Chemical-, physical properties, and bond strength to veneering composites have been evaluated. Static fracture load and fatigue tests as well as simulated use tests have been conducted to evaluate the performance characteristics of Pekkton® Ivory. The test methods were based on established standards and quidelines. Testing has shown that Pekkton® Ivory is equivalent in performance characteristics to the predicate device BioHPP. The acceptance criteria were met.
The summary of application and functional testing indicate that the device is substantially equivalent to the predicate device.
§ 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.