Straumann PURE Ceramic Implant System
Device Facts
| Record ID | K180477 |
|---|---|
| Device Name | Straumann PURE Ceramic Implant System |
| Applicant | Institut Straumann AG |
| Product Code | DZE · Dental |
| Decision Date | Jan 4, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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. 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. 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.
Device Story
Straumann PURE Ceramic Implant System consists of yttrium-stabilized zirconium dioxide (Y-TZP) dental implants and associated titanium (Ti-6Al-7Nb) abutments/components. System used by dental clinicians to restore single-tooth gaps or edentulous/partially edentulous jaws. Implants placed via standard osteotomy protocols; prosthetic components (PUREbase abutments, temporary abutments) attached to implants to support crowns or bridges. CAD/CAM workflow utilized for customized restorations, with digital designs sent to validated milling centers. Device provides structural support for prosthetic teeth, restoring aesthetics and chewing function. Benefits include metal-free implant option for patients with metal sensitivities. Clinical decision-making supported by standard dental imaging and surgical planning.
Clinical Evidence
Bench testing only. Evidence includes dynamic fatigue testing per ISO 14801:2016, implant-to-abutment connection wear analysis, and screw-loosening comparison. Biocompatibility confirmed via material identity to previously cleared predicates (ISO 10993-1). Sterilization validated per ISO 11135 and ISO 17665-1.
Technological Characteristics
Implant: Y-TZP (ISO 13356), ZLA surface. Abutments: Ti-6Al-7Nb. Closure/Healing caps: Titanium Grade 4. Temporary abutments: Ti-6Al-7Nb and PMMA. Connection: 2-piece screw-retained. Sterilization: Ethylene Oxide (implants) or autoclave (reusable components). Workflow: CAD/CAM (CARES Visual v.11) with validated milling.
Indications for Use
Indicated for restoration of single-tooth gaps and edentulous/partially edentulous jaws in adult patients requiring dental implants. Includes use of closure/healing caps for soft tissue management (max 6 months) and temporary abutments for provisional restorations (max 180 days).
Regulatory Classification
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
- Straumann PURE Ceramic Implants (K171769)
Reference Devices
- PURE Ceramic Implants (K151328)
- Zeramex P6 Dental Implant System (K163043)
- Straumann Computer Aided Restoration Services (CARES) Ceramic Coping (K061277)
- Straumann Healing Abutments, Healing Caps, and Closure Screws (K130808)
- Straumann Temporary Abutments VITA CAD-Temp (K122192)
- Straumann Variobase Abutment NNC (K142890)
- Straumann Variobase Abutment RN (K142890)
- Straumann Variobase Abutment WN (K142890)
- Straumann Variobase Abutment NC (K142890)
- Straumann Variobase Abutment RC (K142890)
- IPS e.max CAD MO Coping (K142890)
- IPS e.max CAD LT Crown (K142890)
- IPS e.max CAD HT Crown (K142890)
- coron CoCr Single Unit (K142890)
- Straumann Variobase Abutments (K170354)
- Straumann Variobase Abutments (K170356)
- Straumann Variobase for Crown AS (K173379)
Submission Summary (Full Text)
{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) | <div></div> <img alt="Checked" src="checkbox_checked.png"/> |
|----------------------------------------------|-----------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div></div> <img alt="Unchecked" src="checkbox_unchecked.png"/> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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.gov
"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}------------------------------------------------
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<br>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<br>K163043 – Zeramex P6 Dental Implant System<br>K061277 - Straumann Computer Aided Restoration Services<br>(CARES) Ceramic Coping<br>K130808 - Straumann Healing Abutments, Healing Caps, and<br>Closure Screws<br>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<br>Straumann PURE Ceramic<br>Implant System<br>Straumann PURE Ceramic<br>Implants | K171769<br>Straumann PURE Ceramic<br>Implants | K151328<br>Straumann PURE Ceramic<br>Implants | K163043<br>Zeramex P6 Dental Implant<br>System |
| Indications<br>for Use | The Straumann PURE Ceramic<br>Implant is indicated for the<br>restoration of single-tooth gaps<br>and in edentulous or partially<br>edentulous jaws. The prosthetic<br>restorations used are single<br>crowns, fixed partial or full<br>dentures, which are connected<br>to the implants through the<br>corresponding components. | The Straumann® PURE Ceramic<br>Implant (Monotype) is indicated for<br>restoration in single tooth gaps and<br>in an edentulous or partially<br>edentulous jaw. The prosthetic<br>restorations used are single<br>crowns, fixed partial or full<br>dentures, which are connected to<br>the implants through the<br>corresponding components.<br>The Ø3.3 mm reduced diameter<br>implants are recommended for<br>central and lateral incisors only. | The Straumann® PURE Ceramic<br>Implant (Monotype) is indicated<br>for restoration in single tooth gaps<br>and in an edentulous or partially<br>edentulous jaw. The prosthetic<br>restorations used are single<br>crowns, fixed partial or full<br>dentures, which are connected to<br>the implants through the<br>corresponding components.<br>The Ø3.3 mm reduced diameter<br>implants are recommended for<br>central and lateral incisors only.<br>The Straumann® PURE Ceramic<br>Implant Protective Cap is intended<br>to protect the Straumann® PURE<br>Ceramic Implant (Monotype)<br>during the healing phase after<br>implant placement for up to 6<br>months.<br>Temporary copings are intended<br>to serve as a base for temporary<br>crown or bridge restoration for the<br>Straumann® PURE Ceramic<br>Implant (Monotype) for up to 30<br>days. | The Zeramex® P6 Dental<br>Implant System is intended to be<br>surgically placed in the bone of<br>the upper and lower jaw to<br>provide support for prosthetic<br>devices, such as artificial teeth,<br>in order to restore aesthetics and<br>chewing function.<br>The Zeramex® P6 Dental<br>Implant System can be used for<br>single or multiple unit<br>restorations.<br>The Zeramex® P6 implants are<br>intended for delayed loading.<br>The Zeramex® P6 implants are<br>specially indicated for patients<br>with metal allergies/ intolerances<br>and chronic illness due to metal<br>allergies/intolerances.<br>The Zeramex® P6 (Ø3.3mm SN)<br>implant may only be used in the<br>anterior teeth in the lower jaw<br>and lateral incisor in the upper<br>jaw. |
| Material | Y-TZP according to ISO 13356 | Y-TZP according to ISO 13356 | Y-TZP according to ISO 13356 | Aluminum toughened zirconia |
| Surface<br>Treatment | Sand-blasted, large-grit, acid<br>etched (ZLA®) | Sand-blasted, large-grit, acid<br>etched (ZLA®) | Sand-blasted, large-grit, acid<br>etched (ZLA®) | N/A |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | |
| | Subject<br>Straumann PURE Ceramic<br>Implant System<br>Straumann PURE Ceramic<br>Implants | K171769<br>Straumann PURE Ceramic<br>Implants | K151328<br>Straumann PURE Ceramic<br>Implants | K163043<br>Zeramex P6 Dental Implant<br>System |
| Implant to<br>Abutment<br>Connection | 2-piece Y-TZP dental implant | Integral coping superstructure | Integral coping superstructure | 2-piece Y-TZP dental implant |
| Abutment<br>to Implant<br>Mode of<br>Attachment | Screw-retained | Integral coping superstructure | Integral coping superstructure | Screw-retained or cement-<br>retained |
| Restoration<br>to<br>Abutment<br>Mode of<br>Attachment | Cement-retained | Cement-retained | Cement-retained | Cement-retained |
| Endosteal<br>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<br>Diameter | Ø4.8 mm | Ø3.5 and Ø4.8 mm | Ø3.5 and Ø4.8 mm | N/A |
| Implant<br>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<br>Design | Straight cylindrical implant body | Straight cylindrical implant body | Straight cylindrical implant body | N/A |
| Thread<br>Pitch | 0.8 mm | 0.8 mm | 0.8 mm | N/A |
| Sterilization<br>Method | End user receives product<br>sterilized via Ethylene Oxide to<br>an SAL of 10-6 | End user receives product<br>sterilized via Ethylene Oxide to an<br>SAL of 10-6 | End user receives product<br>sterilized via Ethylene Oxide to an<br>SAL of 10-6 | N/A |
{7}------------------------------------------------
# K180477 – Straumann® PURE® Ceramic Implant System
{8}------------------------------------------------
# K180477 – Straumann® PURE® Ceramic Implant System
| FEATURE | PROPOSED<br>DEVICE | REFERENCE DEVICES | | | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject<br>Straumann PURE<br>Ceramic Implant<br>System<br>CI RD Straumann<br>PUREbase<br>Abutments | K142890<br>Straumann<br>Variobase<br>Abutments | K061277<br>Straumann CARES<br>Ceramic Coping | K170354<br>Straumann<br>Variobase<br>Abutments | K170356<br>Straumann<br>Variobase<br>Abutments | K173379<br>Straumann<br>Variobase<br>Abutments for AS |
| Indications for<br>Use | The CI RD Straumann<br>PUREbase Abutment is<br>a titanium base placed<br>onto Straumann<br>ceramic dental implants<br>to provide support for<br>customized prosthetic<br>restorations and is<br>indicated for screw-<br>retained single tooth or<br>cement-retained single<br>tooth and bridge<br>restorations. All digitally<br>designed copings<br>and/or crowns for use<br>with the Straumann®<br>Variobase Abutment<br>system are intended to<br>be sent to Straumann<br>for manufacture at a<br>validated milling center. | The Straumann®<br>Variobase™ Abutment<br>is a titanium base<br>placed onto Straumann<br>dental implants to<br>provide support for<br>customized prosthetic<br>restorations.<br>Straumann®<br>Variobase™<br>Abutments are<br>indicated for screw-<br>retained single tooth or<br>cement-retained single<br>tooth and bridge<br>restorations. All digitally<br>designed copings<br>and/or crowns for use<br>with the Straumann®<br>Variobase™ Abutment<br>system are intended to<br>be sent to Straumann<br>for manufacture at a<br>validated milling center. | Copings are intended<br>to provide support for<br>prosthetic<br>reconstructions such as<br>crowns or bridges. The<br>Straumann C.A.R.E.S.<br>Ceramic Coping is<br>indicated for cemented<br>restorations. The<br>coping can be used in<br>single tooth<br>replacements and<br>multiple tooth<br>restorations. | The Straumann®<br>Variobase® Abutment<br>is a titanium base<br>placed onto Straumann<br>dental implants to<br>provide support for<br>customized prosthetic<br>restorations.<br>Straumann®<br>Variobase® Abutments<br>are indicated for screw-<br>retained single tooth or<br>cement-retained single<br>tooth and bridge<br>restorations. All digitally<br>designed copings<br>and/or crowns for use<br>with the Straumann®<br>Variobase® Abutment<br>system are intended to<br>be sent to Straumann<br>for manufacture at a<br>validated milling center. | The Straumann®<br>Variobase® Abutment<br>is a titanium base<br>placed onto Straumann<br>dental implants to<br>provide support for<br>customized prosthetic<br>restorations.<br>Straumann®<br>Variobase® Abutments<br>are indicated for screw-<br>retained single tooth or<br>cement-retained single<br>tooth and bridge<br>restorations. All digitally<br>designed copings<br>and/or crowns for use<br>with the Straumann®<br>Variobase® Abutment<br>system are intended to<br>be sent to Straumann<br>for manufacture at a<br>validated milling center. | The Straumann®<br>Variobase® for Crown AS<br>is a titanium base placed<br>onto Straumann dental<br>implants to provide support<br>for customized prosthetic<br>restorations. Straumann®<br>Variobase® for Crown AS<br>are indicated for screw<br>retained single tooth or<br>cement-retained single<br>tooth and bridge<br>restorations. A temporary<br>restoration can be used<br>prior to the insertion of the<br>final components to<br>maintain, stabilize and<br>form the soft tissue during<br>the healing phase.<br>Temporary restorations are<br>indicated to be placed out<br>of occlusion. All digitally<br>designed copings and/or<br>crowns for use with the<br>Straumann Variobase® for<br>Crown AS are intended to<br>be sent to Straumann for<br>manufacture at a validated<br>milling center. |
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | Y-TZP | Ti-6Al-7Nb | Ti-6Al-7Nb | Ti-6Al-7Nb |
| Implant to<br>Abutment<br>Connection | RD connection with<br>a Y-TZP implant<br>fixture and a Ti-6Al-<br>7Nb Abutment | TiZr or Ti implant<br>fixture and a Ti-6Al-<br>7Nb Abutment | TiZr or Ti implant<br>fixture and a Y-TZP<br>abutment | TiZr or Ti implant<br>fixture and a Ti-6Al-<br>7Nb Abutment | TiZr or Ti implant<br>fixture and a Ti-6Al-<br>7Nb Abutment | TiZr or Ti implant<br>fixture and a Ti-6Al-<br>7Nb Abutment |
| FEATURE | PROPOSED<br>DEVICE | REFERENCE DEVICES | | | | |
| | Subject<br>Straumann PURE<br>Ceramic Implant<br>System<br>CI RD Straumann<br>PUREbase<br>Abutments | K142890<br>Straumann<br>Variobase<br>Abutments | K061277<br>Straumann CARES<br>Ceramic Coping | K170354<br>Straumann<br>Variobase<br>Abutments | K170356<br>Straumann<br>Variobase<br>Abutments…
