← Product Code [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE) · K151328 # PURE Ceramic Implants (K151328) _Straumann USA · DZE · Jan 11, 2016 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K151328 ## Device Facts - **Applicant:** Straumann USA - **Product Code:** [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE.md) - **Decision Date:** Jan 11, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3640 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use The Straumann® PURE Ceramic Implant (Monotype) is suitable for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients (unless specific indications and limitations are specified). ## Device Story The Straumann PURE Ceramic Implant is a one-piece (monotype) endosseous dental implant system. It is surgically placed into the upper or lower jaw to replace missing teeth. The device is manufactured from yttrium-stabilized zirconia (Y-TZP) and features a ZLA surface to support osseointegration. The system includes protective caps (PEEK) for the healing phase and temporary copings (PMMA) for temporary restorations. The device is used by dental professionals in a clinical setting. The implant provides a stable foundation for prosthetic restorations, including single crowns and fixed partial or full dentures, which are connected to the integrated abutment. This system benefits patients by providing a metal-free alternative for tooth replacement, restoring both function and aesthetics. ## Clinical Evidence Clinical study included 41 ITT patients with two-year follow-up. 40 patients survived to at least two years (97.6% survival rate), exceeding the 85% protocol acceptance criteria. Biocompatibility was supported by ISO 10993-5 and ISO 10993-18 testing, and a rabbit study comparing unaged and aged implants. ## Technological Characteristics One-piece monotype implant made of yttrium-stabilized zirconia (Y-TZP) conforming to ISO 13356:2008. Features ZLA surface for osseointegration. Protective caps made of PEEK Classix; temporary copings made of PMMA. Sterilization validated per DIN EN 556-1/ANSI AAMI ST67:2011. No internal connection. ## Regulatory Identification An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function. ## Special Controls *Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use. ## Predicate Devices - Z-Look3 Evo SLM ([K120793](/device/K120793.md)) ## Reference Devices - Modification to ITI Dental Implant System ([K033922](/device/K033922.md)) - P.004 Implants ([K062129](/device/K062129.md)) - Straumann® Dental Implant System ([K123784](/device/K123784.md)) - Narrow Neck CrossFit (NNC) Ø3.3 mm Dental Implant System ([K111357](/device/K111357.md)) - Straumann P.004 Cementable Abutments ([K072071](/device/K072071.md)) - Straumann P.004 NC Cementable Abutments ([K080286](/device/K080286.md)) ## Related Devices - [K171769](/device/K171769.md) — Straumann PURE Ceramic Implants · Straumann USA, LLC (On Behalf of Institut Straumann Ag) · Nov 14, 2017 - [K241391](/device/K241391.md) — Straumann® PURE Ceramic Implants · Institut Straumann AG · Dec 10, 2024 - [K180477](/device/K180477.md) — Straumann PURE Ceramic Implant System · Institut Straumann AG · Jan 4, 2019 - [K132585](/device/K132585.md) — ZIBONE CERAMIC DENTAL IMPLANT SYSTEM · Coho Technology Co., Ltd. · Jun 4, 2014 - [K172668](/device/K172668.md) — W Zirconia Implants · Tav Medical , Ltd. · Nov 6, 2018 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with three curved lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 11, 2016 Straumann USA Ms. Nandini Murthy Regulatory Consultant 60 Minuteman Road Andover, Massachusetts 01810 Re: K151328 Trade/Device Name: PURE Ceramic Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 8, 2015 Received: December 9, 2015 Dear Ms. Murthy: 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. {1}------------------------------------------------ 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang S for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page 510(k) Number (if known) K151328 Device Name PURE Ceramic Implants Indications for Use (Describe) The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components. The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only. The Straumann® PURE Ceramic Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 6 months. Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days. Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D) Subpart C) □ Over-The-Counter Use (21 CFR 801 PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number {3}------------------------------------------------ # 510(k) Summary #### 1.1 Submitter's Contact Information Straumann USA, LLC (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 | Phone Number: | 1-978-747-2509 | |---------------|----------------| |---------------|----------------| Fax Number: 1-978-747-0023 Contact Person: Jennifer Jackson Date of Submission: January 11, 2016 #### 1.2 Name of the Device: PURE Ceramic Implants | Trade Name: | Straumann® PURE Ceramic Implants | |-------------|----------------------------------| |-------------|----------------------------------| - Common Name: Endosseous Dental Implant - Classification Name: Endosseous Dental Implant - Regulation Number: §872.3640 - Classification: Class II - Product codes: DZE, NHA #### Straumann® PURE Ceramic Protective Caps 1.2.1 - Straumann® PURE Ceramic Protective Caps Trade Name: - Endosseous Dental Implant Abutment Common Name: ### 1.2.2 Straumann® PURE Ceramic Temporary Copings - Straumann® PURE Ceramic Temporary Copings Trade Name: - Common Name: Endosseous Dental Implant Abutment {4}------------------------------------------------ #### Predicate Device 1.3 ### 1.3.1 Primary Predicate Device - K120793, Z-Look3 Evo SLM . ### 1.3.2 Reference Predicate Device(s) - . K033922, Modification to ITI Dental Implant System - . K062129, P.004 Implants - K123784, Straumann® Dental Implant System . - . K111357, Narrow Neck CrossFit (NNC) Ø3.3 mm Dental Implant System - K072071, Straumann P.004 Cementable Abutments ● - K080286, Straumann P.004 NC Cementable Abutments . #### Device Description 1.4 ### 1.4.1 PURE Ceramic Implants The Straumann® PURE Ceramic Implant (Monotype) is made of 100% yttrium-stabilized zirconia. The endosteal region presents macro- and micro-roughness to support osseointegration (ZLA® surface). The implant has a 1.8 mm high machined neck. The implant features a monotype design where the ceramic abutment for final restoration is already built in. Straumann® PURE Ceramic Implant (Monotype) prosthetic components are identified with RD (Regular Diameter) corresponding to the neck diameter of 4.8 mm, and ND (Narrow Diameter) corresponding to the neck diameter of 3.5 mm. The full range of size ranges of the PURE Ceramic implants are provided in Table 1 below. {5}------------------------------------------------ | K151328 | |----------------------------------| | Straumann® PURE Ceramic Implants | | Implant Overview | Straumann® PURE Ceramic Implant Ø3.3 ND | | Straumann® PURE Ceramic Implant Ø4.1 RD | | | |---------------------------------------------|-----------------------------------------|-----------|-----------------------------------------|-----------|----------| | Prosthetic Platform | ND | ND | RD | RD | | | Abutment height | AH 4 mm | AH 5.5 mm | AH 4 mm | AH 5.5 mm | | | Shoulder diameter | Ø3.5 mm | Ø3.5 mm | Ø4.8 mm | Ø4.8 mm | | | Image: Four Straumann PURE Ceramic Implants | | | | | | | Endosteal diameter | Ø3.3 mm | Ø3.3 mm | Ø4.1 mm | Ø4.1 mm | | | Length | 8 mm | 031.001S | 031.011S | 031.021S | 031.031S | | | 10 mm | 031.002S | 031.012S | 031.022S | 031.032S | | | 12 mm | 031.003S | 031.013S | 031.023S | 031.033S | | | 14 mm | 031.004S | 031.014S | 031.024S | 031.034S | Table 1 – Full range of Straumann® PURE Ceramic Implants ## 1.4.2 Straumann® PURE Ceramic Protective Caps The Protective Caps are manufactured from polyetheretherketone (PEEK Classix). The full range of Protective Caps is provided in Table 2. | Protective Cap Overview | AH 4 mm | AH 5.5 mm | |-------------------------|----------------|------------------| | | Image: AH 4 mm | Image: AH 5.5 mm | | For Ø3.3 (ND) | 031.320 | 031.321 | | For Ø4.1 (RD) | 031.330 | 031.331 | Table 2 – Full range of Straumann® PURE Ceramic Implant Protective Caps #### Straumann® PURE Ceramic Temporary Copings 1.4.3 The temporary copings are manufactured from polymethylmethacrylate (PMMA). The full range of temporary copings is provided in Table 3. {6}------------------------------------------------ K151328 Straumann® PURE Ceramic Implants | Temporary Coping Overview | For Crowns | For Bridges | |---------------------------|--------------|---------------| | | Image: crown | Image: bridge | | For Ø3.3 (ND) | 031.300 | 031.301 | | For Ø4.1 (RD) | 031.310 | 031.311 | Table 3 – Full range of Straumann® PURE Ceramic Implant temporary copings #### 1.5 Intended Use #### Straumann® PURE Ceramic Implants 1.5.1 The Straumann® PURE Ceramic Implant (Monotype) is suitable for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients (unless specific indications and limitations are specified). #### 1.6 Indications for Use ## 1.6.1 Straumann® PURE Ceramic Implants The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components. The Ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only. #### Straumann® PURE Ceramic Protective Caps 1.6.2 The Straumann® PURE Ceramic Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 6 months. ### 1.6.3 Straumann® PURE Ceramic Temporary Copings Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days. Straumann USA, LLC {7}------------------------------------------------ ### 1.7 Technological Characteristics The Straumann® PURE Ceramic Implant is a one-piece monotype implant and therefore does not have an internal connection. Table 4 below provides for a comparison of key technological characteristics and indications between the Straumann® PURE Ceramic Implant and the primary predicate device. The indications are substantially equivalent to the primary predicate, as any differences relate to placement limitation due to reduced diameter implant size and the addition of protective cap and temporary coping device components. | Features | Straumann® PURE Ceramic Implants<br>(K151328) | Predicate Z-Look3 Evo SLM<br>(K120793) | |--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>use | The Straumann® PURE Ceramic Implant<br>(Monotype) is indicated for restoration in single<br>tooth gaps and in an edentulous or partially<br>edentulous jaw. The prosthetic restorations used<br>are single crowns, fixed partial or full dentures,<br>which are connected to the implants through the<br>corresponding components.<br>The ø3.3 mm reduced diameter implants are<br>recommended for central and lateral incisors<br>only.<br>The Straumann® PURE Ceramic Implant<br>Protective Cap is intended to protect the<br>Straumann® PURE Ceramic Implant (Monotype)<br>during the healing phase after implant placement<br>for up to 6 months.<br>Temporary copings are intended to serve as a<br>base for temporary crown or bridge restoration<br>for the Straumann® PURE Ceramic Implant<br>(Monotype) for up to 30 days. | Z-look3 evo slm implants are designed<br>for surgical implantation into the upper<br>and lower jaw for the attachment of<br>prosthodontic appliances to replace<br>missing teeth. The z-look3 evo slm<br>implant system is also suitable for<br>patients with metal allergies and the<br>chronic diseases resulting from them. | | Material | Y-TZP | Y-TZP | | Implant Design | Cylindrical Monotype | Cylindrical Monotype | | Apical Diameter | Ø3.3 and Ø4.1 mm | Ø3.6, Ø4.0, and Ø5.0 mm | | Length | 8, 10, 12, and 14 mm | 8, 10, 11.5, and 13 mm | | Implant/Abutment<br>connection | None (Monotype) | None (Monotype) | Table 4 – Comparison of Straumann® PURE Ceramic Implants to Predicate Z-Look3 Evo SLM #### 1.8 Performance Testing Dynamic fatigue, static strength, insertion torque and surface characterization tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and showed that the Straumann® PURE Ceramic implants were equivalent to the predicate devices. Specifically, the fatigue strength of the Ø3.3 mm Straumann® PURE ceramic implant was equivalent to the Ø3.6 mm predicate device's fatigue strength. The insertion torque values of the Straumann® PURE Ceramic Ø3.3 mm implant were {8}------------------------------------------------ measured and compared to the values of a predicate reference device (Straumann® NNC implant, K111357). MRI testing was performed to support the MRI statements in Straumann® PURE Ceramic labeling. The Straumann® PURE Ceramic Implants are manufactured from yttrium-stabilized zirconium oxide (Y-TZP). The material conforms to ISO 13356:2008, Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). In addition to prior proven biocompatibility of implant material used, including a toxicological evaluation report and conformance to ISO13356, the following testing was performed: - Cytotoxicity according to ISO 10993-5:2009, Biological evaluation of medical devices -. Part 5: Test for in vitro cytotoxicity. - . Chemical Analysis (organic and inorganic) according to ISO 10993-18:2009, Biological evaluation of medical devices – Part 18: Chemical characterization of materials. - . A rabbit study comparing unaged ceramic implants with aged implants. All of the testing above, along with a literature review, confirmed the biocompatibility of the Straumann® PURE Ceramic implants. Sterilization validation of the Straumann® PURE Ceramic implants, in accordance with DIN EN 556-1:2002 (equivalent to ANSI AAMI ST67:2011), Sterilization of medical devices – Requirements for medical devices to be designated "STERILE" – Part 1: requirements for terminally sterilized devices, was completed. The sterilization process for the provisional components as recommended in labeling was also validated according to applicable recommendations in the FDA Guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". Straumann performed accelerated and real time aging testing to support the labeled shelf life. Clinical study results support the equivalence of the Straumann® PURE Ceramic implants to predicate devices. Among the 41 ITT patients with complete follow-up through two years, 40 survived to at least two years (point estimate of 97.6%), which exceeded the acceptance criteria of 85% in the protocol. #### Conclusion 1.9 The documentation submitted in this premarket notification demonstrates that the Straumann® PURE Ceramic Implants are substantially equivalent to the predicate devices. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K151328](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K151328) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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