(306 days)
No
The description focuses on the material properties and manufacturing process (CAD/CAM milling/pressing) of a thermoplastic for dental restorations. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a material (semi-crystalline thermoplastic) used to manufacture dental restorations, not a therapeutic device itself.
No
The device description clearly states its use for manufacturing permanent crowns, bridges, and denture frameworks, which are restorative applications, not diagnostic ones.
No
The device description clearly states that Pekkton® Ivory is a "semi-crystalline thermoplastic supplied in milling blanks and press blanks" used to manufacture physical dental restorations. This indicates it is a material, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for the fabrication of dental restorations (crowns, bridges, dentures, etc.) that are placed in the patient's mouth. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The description confirms it's a material used by dental technicians to manufacture these dental restorations.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on the mechanical and physical properties of the material and its performance as a dental restoration, not on its ability to detect or measure biological markers.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device is used in vivo (within the body) as a dental prosthetic material.
N/A
Intended Use / Indications for Use
- · 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.
Product codes (comma separated list FDA assigned to the subject device)
EBF, POW
Device Description
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.
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
Dental technician
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: Cytotoxicity (ISO 10993-5:2009), Irritation (ISO 10993-10:2010), Delayed-type hypersensitivity (ISO 10993-10:2010), Systemic Toxicity (ISO 10993-11:2006), Subchronic and chronic systemic toxicity (ISO 10993-11:2006), Implantation (ISO 10993-6:2007), Genotoxicity (ISO 10993-3:2014), Chemical characterization (ISO 10993-18:2009), USP Plastic Class VI (USP 34 (88)).
Testing has shown that Pekkton® Ivory is equivalent in performance characteristics to the predicate device BioHPP. The acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bond strength to veneering resins: > 15 MPa (Standard ISO EN 10477:2004 requires 5 MPa)
E-Modulus: approx. 5000 MPa
Flexural strength: 200 MPa
Water absorption: 8.7 ug/mm3 (Standard ISO 4049-2009 requires water sorption lower than 40 ug/mm3)
Water solubility: 0.2 ug/mm3 (Standard ISO 4049-2009 requires water solubility lower than 7.5 ug/mm3)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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);
1
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
2
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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3
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 SA
Rue de Boujean 122
CH-2501 Biel / Bienne
Phone : +41 58 360 20 00
Fax : +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
4
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 | BioHPP | |||
| breCAM.BioHPP | ||||
| 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. 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® Ivory | |||
| Definitive 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 frameworks | ||||
| Secondary 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-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) | ||||
| CAD/CAM Milling | 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 |
| E-Modulus | : | approx. 4083 – 4630 MPa | approx. 5000 MPa | ASTM-D638 |
| Flexural | ||||
| strength | : | 163 – 179 MPa | 200 MPa | ASTM-D790 |
| Water | ||||
| absorption | : | 6.5 ug/mm3 | 8.7 ug/mm3 | Standard ISO 4049-2009 requires water sorption lower than 40 ug/mm3 |
| Water | ||||
| solubility | : | 0.1 ug/mm3 | 0.2 ug/mm3 | Standard ISO 4049-2009 requires water solubility lower than 7.5 ug/mm3 |
5
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 chronic | ||
| systemic | ||
| toxicity | 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.