(316 days)
No
The document describes a dental implant system and its components, focusing on materials, mechanical properties, and intended use. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is a dental implant system used for the restoration of single-tooth gaps and in edentulous or partially edentulous jaws, which directly addresses a medical condition (edentulism) and restores function, classifying it as a therapeutic device.
No
The device description and intended use indicate that the Straumann PURE Ceramic Implant and its associated components are used for the mechanical restoration and protection of dental structures, not for diagnosing conditions.
No
The device description clearly details physical components made of materials like yttrium-stabilized zirconium dioxide and titanium, which are hardware. The performance studies also focus on biocompatibility, sterilization, and mechanical testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dental implant system used for the restoration of teeth in the jaw. This is a surgical and prosthetic application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical components of the dental implant system (implant, caps, abutments) and their materials. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: The text does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a physiological or pathological state
- Being used for diagnosis, monitoring, or screening of diseases
The device is a medical device used for surgical and restorative procedures within the body, not for in vitro analysis.
N/A
Intended Use / Indications for Use
Straumann PURE Ceramic Implant:
The Straumann PURE Ceramic Implant is indicated for the restoration of single-tooth gaps and in edentulous or partially edentulous jaws. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
Closure and healing caps:
Closure and Healing caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Closure and Healing caps should be used only with suitable implant connections. Do not use healing components for longer than 6 months.
Temporary Abutments:
The provisional components are intended to serve as a base for temporary crown or bridge restoration out of occlusion for the Strauman® PURE Ceramic Implant System. The Straumann® Temporary Abutment VITA CAD-Temp® for the Straumann® PURE Ceramic Implant is indicated for temporary usage of up to 180 days.
CI RD Straumann PUREbase Abutments:
CI RD Straumann PUREbase abutment is a titanium base placed onto Straumann ceramic dental implants to provide support for customized prosthetic restorations and is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Straumann PURE Ceramic Implant is a dental implant made out of yttriumstabilized zirconium dioxide (Y-TZP). The Straumann PURE Ceramic Implant is based on features of the Straumann PURE Ceramic implant Monotype. Straumann PURE Ceramic Implants can be placed using the existing instruments using the same osteotomy preparation protocol as for Bone Level implants. The subject implant is a two -piece implant and is available in Ø4.1 mm with lengths of 8, 10, 12, and 14 mm.
The Closure and Healing caps are screws machined as one piece and come in three gingival heights to accommodate individual gingival thickness. The material of the devices is titanium grade 4. The Closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submerged (submucosal) healing protocols and do not support a prosthetic restoration. Healing caps are screwed into the implant to protect the inner configuration in cases of transmucosal healing protocols and are placed out of occlusion and do not support a prosthetic restoration.
The Temporary Abutments are used to serve as a temporary crown or bridge restoration for the Straumann PURE Ceramic Implant System.
The CI RD Straumann PUREbase Abutment for Ceramic implant is a premanufactured (stock) abutment (the first piece of the two-piece abutment), sometimes referred to as "Tibase", and is used as a base when fabricating a CAD/CAM customized restoration (the second piece of the two-piece abutment). The assembly of the two-pieces becomes a finished medical device after cementation of the CAD/CAM customized restoration on the PURE base abutment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jaws
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)
Biocompatibility Testing
The subject device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility (according to ISO 10993-1:2009) were raised.
Sterilization
Sterilization validation performed per ISO 11135, Sterilization of healthcare products – Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices, using the Half Cycle Overkill Approach. The validation demonstrates that the sterilization process and equipment is capable of reliably and consistently sterilizing the subject device to a minimum Sterility Assurance Level (SAL) of 10-6.
Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.
The sterilization process for the Straumann PURE temporary abutment and CL RD Straumann PUREbase abutments as recommended in the labeling was validated according to applicable recommnedations inf the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015" and ISO 17665-1:2006 "Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices".
Mechanical Testing
Dynamic fatigue 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 Implant Abutments" and ISO 14801:2016 and demonstrated the Straumann PURE Ceramic Implant, Straumann PURE temporary abutments, and CI RD Straumann PUREbase abutments are equivalent to the predicate and reference devices.
Two additional bench tests were conducted after fatigue testing: Implant-to-abutment connection comparison to evaluate wear of the surfaces of the implant body, abutment and fixation screw and screw loosening comparison. Both data produced concluded of comparable behavior of the subject device to the reference devices in terms of wear on the implant-to-abutment connection and screw loosening.
A literature review was provided to evaluate the risk of screw loosening with ceramic abutments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K171769 - Straumann PURE Ceramic Implants
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.
K151328 – PURE Ceramic Implants, K163043 – Zeramex P6 Dental Implant System, K061277 - Straumann Computer Aided Restoration Services (CARES) Ceramic Coping, K130808 - Straumann Healing Abutments, Healing Caps, and Closure Screws, K122192 - Straumann Temporary Abutments VITA CAD-Temp, K142890 – Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit, K170354 – Straumann Variobase Abutments, K170356 – Straumann Variobase Abutments, K173379 – Straumann Variobase for Crown AS
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
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services 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.
January 4, 2019
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K180477
Trade/Device Name: Straumann PURE Ceramic Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 3, 2018 Received: December 4, 2018
Dear Jennifer Jackson:
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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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.
Andrew I. Steen -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) K180477
Device Name Straumann PURE Ceramic Implant System
Indications for Use (Describe)
Straumann PURE Ceramic Implant:
The Straumann PURE Ceramic Implant is indicated for the restoration of single-tooth gaps and in edentulous or partially edentulous jaws. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
Closure and healing caps:
Closure and Healing caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Closure and Healing caps should be used only with suitable implant connections. Do not use healing components for longer than 6 months.
Temporary Abutments:
The provisional components are intended to serve as a base for temporary crown or bridge restoration out of occlusion for the Strauman® PURE Ceramic Implant System. The Straumann® Temporary Abutment VITA CAD-Temp® for the Straumann® PURE Ceramic Implant is indicated for temporary usage of up to 180 days.
CI RD Straumann PUREbase Abutments:
CI RD Straumann PUREbase abutment is a titanium base placed onto Straumann ceramic dental implants to provide support for customized prosthetic restorations and is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
| 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
K180477 – Straumann® PURE® Ceramic Implant System
510(k) Summary
510(k) Summary 5
Submitter 5.1
Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
| Phone Number: | (978) 747-2509 |
|---|---|
| --------------- | ---------------- |
Fax Number: (978) 747-0023
Contact Person: Jennifer M. Jackson, MS
Date of Submission: January 4, 2019
5.2 Device
| Trade Name: | Straumann PURE Ceramic Implant System |
|---|---|
| Common Name: | Endosseous Dental Implant |
| Endosseous Dental Implant Abutment | |
| Classification Name: | 21 CFR 872.3640 |
| Regulatory Class: | II |
| Primary Product Code: | DZE |
| Secondary Product Code: | NHA |
Predicate Device 5.3
| Primary Predicate: | K171769 - Straumann PURE Ceramic Implants |
|---|---|
| Reference Devices: | K151328 – PURE Ceramic Implants |
| K163043 – Zeramex P6 Dental Implant System | |
| K061277 - Straumann Computer Aided Restoration Services | |
| (CARES) Ceramic Coping | |
| K130808 - Straumann Healing Abutments, Healing Caps, and | |
| Closure Screws | |
| K122192 - Straumann Temporary Abutments VITA CAD-Temp |
4
K180477 – Straumann® PURE® Ceramic Implant System
510(k) Summary
K142890 – Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit K170354 – Straumann Variobase Abutments K170356 – Straumann Variobase Abutments K173379 – Straumann Variobase for Crown AS
5.4 Device Description
The Straumann PURE Ceramic Implant is a dental implant made out of yttriumstabilized zirconium dioxide (Y-TZP). The Straumann PURE Ceramic Implant is based on features of the Straumann PURE Ceramic implant Monotype. Straumann PURE Ceramic Implants can be placed using the existing instruments using the same osteotomy preparation protocol as for Bone Level implants. The subject implant is a two -piece implant and is available in Ø4.1 mm with lengths of 8, 10, 12, and 14 mm.
The Closure and Healing caps are screws machined as one piece and come in three gingival heights to accommodate individual gingival thickness. The material of the devices is titanium grade 4. The Closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submerged (submucosal) healing protocols and do not support a prosthetic restoration. Healing caps are screwed into the implant to protect the inner configuration in cases of transmucosal healing protocols and are placed out of occlusion and do not support a prosthetic restoration.
The Temporary Abutments are used to serve as a temporary crown or bridge restoration for the Straumann PURE Ceramic Implant System.
The CI RD Straumann PUREbase Abutment for Ceramic implant is a premanufactured (stock) abutment (the first piece of the two-piece abutment), sometimes referred to as "Tibase", and is used as a base when fabricating a CAD/CAM customized restoration (the second piece of the two-piece abutment). The assembly of the two-
5
K180477 – Straumann® PURE® Ceramic Implant System
510(k) Summary
pieces becomes a finished medical device after cementation of the CAD/CAM customized restoration on the PURE base abutment.
5.5 Indications for Use
The Straumann PURE Ceramic Implant is indicated for the restoration of single-tooth gaps and in edentulous or partially edentulous jaws. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
The Closure and Healing caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Closure and Healing caps should be used only with suitable implant connections. Do not use healing components for longer than 6 months.
The provisional components are intended to serve as a base for temporary crown or bridge restoration out of occlusion for the Straumann® PURE Ceramic Implant System. The Straumann® Temporary Abutment VITA CAD-Temp® for the Straumann® PURE Ceramic Implant is indicated for temporary usage of up to 180 days.
The CI RD Straumann PUREbase Abutment is a titanium base placed onto Straumann ceramic dental implants to provide support for customized prosthetic restorations and is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
5.6 Technological Characteristics
The technological characteristics of the subjects devices are compared to the primary predicate and reference devices in the following tables:
6
K180477 – Straumann® PURE® Ceramic Implant System
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | |
|---|---|---|---|---|
| Subject | ||||
| Straumann PURE Ceramic | ||||
| Implant System | ||||
| Straumann PURE Ceramic | ||||
| Implants | K171769 | |||
| Straumann PURE Ceramic | ||||
| Implants | K151328 | |||
| Straumann PURE Ceramic | ||||
| Implants | K163043 | |||
| Zeramex P6 Dental Implant | ||||
| System | ||||
| Indications | ||||
| for Use | The Straumann PURE Ceramic | |||
| Implant is indicated for the | ||||
| restoration of single-tooth gaps | ||||
| and in edentulous or partially | ||||
| edentulous jaws. The prosthetic | ||||
| restorations used are single | ||||
| crowns, fixed partial or full | ||||
| dentures, which are connected | ||||
| to the implants through the | ||||
| corresponding components. | 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 (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. | The Zeramex® P6 Dental | |||
| Implant System is intended to be | ||||
| surgically placed in the bone of | ||||
| the upper and lower jaw to | ||||
| provide support for prosthetic | ||||
| devices, such as artificial teeth, | ||||
| in order to restore aesthetics and | ||||
| chewing function. | ||||
| The Zeramex® P6 Dental | ||||
| Implant System can be used for | ||||
| single or multiple unit | ||||
| restorations. | ||||
| The Zeramex® P6 implants are | ||||
| intended for delayed loading. | ||||
| The Zeramex® P6 implants are | ||||
| specially indicated for patients | ||||
| with metal allergies/ intolerances | ||||
| and chronic illness due to metal | ||||
| allergies/intolerances. | ||||
| The Zeramex® P6 (Ø3.3mm SN) | ||||
| implant may only be used in the | ||||
| anterior teeth in the lower jaw | ||||
| and lateral incisor in the upper | ||||
| jaw. | ||||
| Material | Y-TZP according to ISO 13356 | Y-TZP according to ISO 13356 | Y-TZP according to ISO 13356 | Aluminum toughened zirconia |
| Surface | ||||
| Treatment | Sand-blasted, large-grit, acid | |||
| etched (ZLA®) | Sand-blasted, large-grit, acid | |||
| etched (ZLA®) | Sand-blasted, large-grit, acid | |||
| etched (ZLA®) | N/A | |||
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | |
| Subject | ||||
| Straumann PURE Ceramic | ||||
| Implant System | ||||
| Straumann PURE Ceramic | ||||
| Implants | K171769 | |||
| Straumann PURE Ceramic | ||||
| Implants | K151328 | |||
| Straumann PURE Ceramic | ||||
| Implants | K163043 | |||
| Zeramex P6 Dental Implant | ||||
| System | ||||
| Implant to | ||||
| Abutment | ||||
| Connection | 2-piece Y-TZP dental implant | Integral coping superstructure | Integral coping superstructure | 2-piece Y-TZP dental implant |
| Abutment | ||||
| to Implant | ||||
| Mode of | ||||
| Attachment | Screw-retained | Integral coping superstructure | Integral coping superstructure | Screw-retained or cement- |
| retained | ||||
| Restoration | ||||
| to | ||||
| Abutment | ||||
| Mode of | ||||
| Attachment | Cement-retained | Cement-retained | Cement-retained | Cement-retained |
| Endosteal | ||||
| Diameter | Ø4.1 mm | Ø3.3 and Ø4.1 mm | Ø3.3 and Ø4.1 mm | Ø3.3, Ø4.1, and Ø4.8 mm |
| Platform | ||||
| Diameter | Ø4.8 mm | Ø3.5 and Ø4.8 mm | Ø3.5 and Ø4.8 mm | N/A |
| Implant | ||||
| Length | 8, 10, 12, and 14 mm | 8, 10, 12, and 14 mm | 8, 10, 12, and 14 mm | 8, 10, and 12 mm |
| Implant | ||||
| Design | Straight cylindrical implant body | Straight cylindrical implant body | Straight cylindrical implant body | N/A |
| Thread | ||||
| Pitch | 0.8 mm | 0.8 mm | 0.8 mm | N/A |
| Sterilization | ||||
| Method | End user receives product | |||
| sterilized via Ethylene Oxide to | ||||
| an SAL of 10-6 | End user receives product | |||
| sterilized via Ethylene Oxide to an | ||||
| SAL of 10-6 | End user receives product | |||
| sterilized via Ethylene Oxide to an | ||||
| SAL of 10-6 | N/A |
7
K180477 – Straumann® PURE® Ceramic Implant System
8
K180477 – Straumann® PURE® Ceramic Implant System
| FEATURE | PROPOSED
DEVICE | REFERENCE DEVICES | | | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject
Straumann PURE
Ceramic Implant
System
CI RD Straumann
PUREbase
Abutments | K142890
Straumann
Variobase
Abutments | K061277
Straumann CARES
Ceramic Coping | K170354
Straumann
Variobase
Abutments | K170356
Straumann
Variobase
Abutments | K173379
Straumann
Variobase
Abutments for AS |
| Indications for
Use | The CI RD Straumann
PUREbase Abutment is
a titanium base placed
onto Straumann
ceramic dental implants
to provide support for
customized prosthetic
restorations and is
indicated for screw-
retained single tooth or
cement-retained single
tooth and bridge
restorations. All digitally
designed copings
and/or crowns for use
with the Straumann®
Variobase Abutment
system are intended to
be sent to Straumann
for manufacture at a
validated milling center. | The Straumann®
Variobase™ Abutment
is a titanium base
placed onto Straumann
dental implants to
provide support for
customized prosthetic
restorations.
Straumann®
Variobase™
Abutments are
indicated for screw-
retained single tooth or
cement-retained single
tooth and bridge
restorations. All digitally
designed copings
and/or crowns for use
with the Straumann®
Variobase™ Abutment
system are intended to
be sent to Straumann
for manufacture at a
validated milling center. | Copings are intended
to provide support for
prosthetic
reconstructions such as
crowns or bridges. The
Straumann C.A.R.E.S.
Ceramic Coping is
indicated for cemented
restorations. The
coping can be used in
single tooth
replacements and
multiple tooth
restorations. | The Straumann®
Variobase® Abutment
is a titanium base
placed onto Straumann
dental implants to
provide support for
customized prosthetic
restorations.
Straumann®
Variobase® Abutments
are indicated for screw-
retained single tooth or
cement-retained single
tooth and bridge
restorations. All digitally
designed copings
and/or crowns for use
with the Straumann®
Variobase® Abutment
system are intended to
be sent to Straumann
for manufacture at a
validated milling center. | The Straumann®
Variobase® Abutment
is a titanium base
placed onto Straumann
dental implants to
provide support for
customized prosthetic
restorations.
Straumann®
Variobase® Abutments
are indicated for screw-
retained single tooth or
cement-retained single
tooth and bridge
restorations. All digitally
designed copings
and/or crowns for use
with the Straumann®
Variobase® Abutment
system are intended to
be sent to Straumann
for manufacture at a
validated milling center. | The Straumann®
Variobase® for Crown AS
is a titanium base placed
onto Straumann dental
implants to provide support
for customized prosthetic
restorations. Straumann®
Variobase® for Crown AS
are indicated for screw
retained single tooth or
cement-retained single
tooth and bridge
restorations. A temporary
restoration can be used
prior to the insertion of the
final components to
maintain, stabilize and
form the soft tissue during
the healing phase.
Temporary restorations are
indicated to be placed out
of occlusion. All digitally
designed copings and/or
crowns for use with the
Straumann Variobase® for
Crown AS are intended to
be sent to Straumann for
manufacture at a validated
milling center. |
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | Y-TZP | Ti-6Al-7Nb | Ti-6Al-7Nb | Ti-6Al-7Nb |
| Implant to
Abutment
Connection | RD connection with
a Y-TZP implant
fixture and a Ti-6Al-
7Nb Abutment | TiZr or Ti implant
fixture and a Ti-6Al-
7Nb Abutment | TiZr or Ti implant
fixture and a Y-TZP
abutment | TiZr or Ti implant
fixture and a Ti-6Al-
7Nb Abutment | TiZr or Ti implant
fixture and a Ti-6Al-
7Nb Abutment | TiZr or Ti implant
fixture and a Ti-6Al-
7Nb Abutment |
| FEATURE | PROPOSED
DEVICE | REFERENCE DEVICES | | | | |
| | Subject
Straumann PURE
Ceramic Implant
System
CI RD Straumann
PUREbase
Abutments | K142890
Straumann
Variobase
Abutments | K061277
Straumann CARES
Ceramic Coping | K170354
Straumann
Variobase
Abutments | K170356
Straumann
Variobase
Abutments | K173379
Straumann
Variobase
Abutments for AS |
| Diameter | Ø3.6 mm | Ø3.8 - Ø7.0 mm | N/A | Ø3.8 - Ø7.0 mm | Ø3.8 - Ø7.0 mm | Ø3.8 - Ø7.0 mm |
| Overall Height | 6.5 – 8.5 mm | 5.9 – 8.9 mm | N/A | 5.9 – 8.9 mm | 5.9 – 8.9 mm | N/A |
| Coping/ Crown
Material | Digital Workflow:
polycon® ae
(temporary)
zerion® LT/HT
(permanent)
zerion® ML/UTML
(permanent)
IPS e.max CAD
MO/LT/HT
(permanent)
n!ce (permanent) | Traditional Workflow:
Type 4 Metals (ISO
22674)
IPS e.max® Press
Ceramic
Digital Workflow:
polycon® ae
(temporary)
zerion® (permanent)
IPS e.max® CAD
Ceramic
(permanent)
coron® (permanent) | N/A | Digital Workflow:
n!ce (permanent) | Digital Workflow:
zerion® ML/UTML
(permanent) | Traditional Workflow:
Type 4 Metals (ISO
22674)
IPS e.max® Press
Ceramic
Digital Workflow:
polycon® ae
(temporary)
zerion® (permanent)
IPS e.max® CAD
Ceramic
(permanent)
coron® (permanent)
zerion ML/UTML
(permanent)
n!ce (permanent) |
| Maximum
Angulation | 30° | 30° | 30° | 30° | 30° | 30° |
| Design
Workflow | CAD with CARES
Visual v.11 | Wax-up or CAD | N/A | Wax-up or CAD | Wax-up or CAD | CAD with CARES
Visual v.11 |
| FEATURE | PROPOSED
DEVICE | REFERENCE DEVICES | | | | |
| | Subject
Straumann PURE
Ceramic Implant
System
CI RD Straumann
PUREbase
Abutments | K142890
Straumann
Variobase
Abutments | K061277
Straumann CARES
Ceramic Coping | K170354
Straumann
Variobase
Abutments | K170356
Straumann
Variobase
Abutments | K173379
Straumann
Variobase
Abutments for AS |
| Manufacturing
Workflow | Straumann Milling | Traditional casting or
pressing or
Straumann Milling | N/A | Straumann Milling | Straumann Milling | Traditional casting or
pressing or
Straumann Milling |
| Sterilization
Method | Non-sterile - End
user sterilized via
autoclave | Non-sterile - End
user sterilized via
autoclave | N/A | Non-sterile - End
user sterilized via
autoclave | Non-sterile - End
user sterilized via
autoclave | Non-sterile - End
user sterilized via
autoclave |
| Mode of
Attachment | Screw-retained or
cement-retained | Screw-retained or
cement-retained | N/A | Screw-retained or
cement-retained | Screw-retained or
cement-retained | Screw-retained or
cement-retained |
9
K180477 – Straumann® PURE® Ceramic Implant System
10
K180477 – Straumann® PURE® Ceramic Implant System
11
K180477 – Straumann® PURE® Ceramic Implant System
| FEATURE | PROPOSED DEVICE | REFERENCE DEVICES |
|---|---|---|
| Subject | ||
| Straumann PURE Ceramic Implant | ||
| System | ||
| Closure and Healing Caps | K130808 | |
| Straumann Healing Abutments, | ||
| Healing Caps, and Closure Screws | ||
| Indications for | ||
| Use | The Closure and Healing caps are | |
| intended for use with the Straumann | ||
| Dental Implant System (SDIS) to protect | ||
| the inner configuration of the implant and | ||
| maintain, stabilize and form the soft | ||
| tissue during the healing process. | ||
| Closure and Healing caps should be used | ||
| only with suitable implant connections. | ||
| Do not use healing components for | ||
| longer than 6 months. | Closure Screws, healing caps, and | |
| healing abutments, are intended for use | ||
| with the Straumann Dental Implant | ||
| System (SDIS) to protect the inner | ||
| configuration of the implant and maintain, | ||
| stabilize and form the soft tissue during | ||
| the healing process. | ||
| Customizable healing abutments made of | ||
| PEEK are for use for up to 6 months. | ||
| Material | Titanium Grade 4 | Titanium Grade 4 |
| Implant to Cap | ||
| Connection | RD with a Y-TZP implant fixture and a Ti | |
| Cap | RN/WN/NNC connections with TiZr or Ti | |
| Implant fixture and Ti Cap | ||
| Implant to Cap | ||
| Mode of | ||
| Attachment | Screw-retained | Screw-retained |
| Diameter | Closure Cap: Ø4.8 mm | |
| Healing Cap: Ø5.2 mm | Closure and Healing Caps: from Ø3.5 – | |
| Ø5.5 mm | ||
| Overall Height | Closure Cap: 4.6 mm | |
| Healing Cap: 6.2 and 7.2 mm | Closure Cap: 6.2 and 6.8 mm | |
| Healing Cap: 8.1 - 11.1 mm | ||
| Gingival | ||
| Height | Closure Cap: 0.5 mm | |
| Healing Cap: 2.0 and 3.0 mm | Closure Cap: 0 and 0.5 mm | |
| Healing Cap: 2.0 and 3.0 mm | ||
| Sterilization | ||
| Method | End user receives product sterilized via | |
| Irradiation to an SAL of 10-6 |
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K180477 – Straumann® PURE® Ceramic Implant System
510(k) Summary
| FEATURE | PROPOSED DEVICE | REFERENCE DEVICES |
|---|---|---|
| Subject | ||
| Straumann PURE Ceramic Implant | ||
| System | K122192 | |
| Temporary Abutments | Straumann Temporary Abutments | |
| VITA CAD-Temp | ||
| Indications for | ||
| Use | The provisional components are intended | |
| to serve as a base for temporary crown or | ||
| bridge restoration out of occlusion for the | ||
| Straumann® PURE Ceramic Implant | ||
| System. The Straumann® Temporary | ||
| Abutment VITA CAD-Temp® for the | ||
| Straumann® PURE Ceramic Implant is | ||
| indicated for temporary usage of up to | ||
| 180 days. | Straumann Temporary Abutments VITA | |
| CAD-Temp are indicated for use with | ||
| Straumann Bone Level and Tissue Level | ||
| implants for temporary crown and bridge | ||
| restorations, and to maintain, stabilize | ||
| and shape the soft tissue during the | ||
| healing phase for up to six months, and | ||
| should be placed out of occlusion. | ||
| Material | Ti-6Al-7Nb and polymethyl methacrylate | |
| (PMMA) | Ti-6Al-7Nb and polymethyl methacrylate | |
| (PMMA) | ||
| Implant to | ||
| Abutment | ||
| Connection | RD connection with a Y-TZP implant | |
| fixture and a Ti-6Al-7Nb temporary | ||
| abutment | RC/RN connection with TiZr or Ti | |
| implants and a Ti-6Al-7Nb temporary | ||
| abutment | ||
| Diameter | Ø7.0 mm | Ø3.7 – Ø7.0 mm |
| Overall Height | 12.3 mm | 12.1 – 16.4 mm |
| Maximum | ||
| Angulation | 30° | 30° |
| Manufacturing | ||
| Workflow | Can be customized using common dental | |
| burs | Can be customized using common dental | |
| burs | ||
| Sterilization | ||
| Method | Non-sterile | |
| End user sterilized via autoclave | Non-sterile | |
| End user sterilized via autoclave |
Performance Data 5.7
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The subject device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility (according to ISO 10993-1:2009) were raised.
Sterilization
Sterilization validation performed per ISO 11135, Sterilization of healthcare products – Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices, using the Half Cycle Overkill Approach. The
13
K180477 – Straumann® PURE® Ceramic Implant System
510(k) Summary
validation demonstrates that the sterilization process and equipment is capable of reliably and consistently sterilizing the subject device to a minimum Sterility Assurance Level (SAL) of 10-6.
Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.
The sterilization process for the Straumann PURE temporary abutment and CL RD Straumann PUREbase abutments as recommended in the labeling was validated according to applicable recommnedations inf the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015" and ISO 17665-1:2006 "Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices".
Mechanical Testing
Dynamic fatigue 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 Implant Abutments" and ISO 14801:2016 and demonstrated the Straumann PURE Ceramic Implant, Straumann PURE temporary abutments, and CI RD Straumann PUREbase abutments are equivalent to the predicate and reference devices.
Two additional bench tests were conducted after fatigue testing: Implant-to-abutment connection comparison to evaluate wear of the surfaces of the implant body, abutment and fixation screw and screw loosening comparison. Both data produced concluded of comparable behavior of the subject device to the reference devices in terms of wear on the implant-to-abutment connection and screw loosening.
A literature review was provided to evaluate the risk of screw loosening with ceramic abutments.
14
K180477 – Straumann® PURE® Ceramic Implant System
510(k) Summary
Conclusion 5.8
Based upon the assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate and/or reference devices.