Who is the manufacturer of Neodent Implant System - Zirconia Implant System?

Jjgc Industria E Comercio DE Materiais Dentarios S.A. filed the 510(k) submission for Neodent Implant System - Zirconia Implant System (K201491).

What is the FDA product code for Neodent Implant System - Zirconia Implant System?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Neodent Implant System - Zirconia Implant System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Neodent Implant System - Zirconia Implant System?

Neodent Implant System - CM Line (K101945).

Who can help prepare an FDA 510(k) submission like Neodent Implant System - Zirconia Implant System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Neodent Implant System - Zirconia Implant System

K201491 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · DZE · Dec 22, 2020 · Dental

Device Facts

Record ID	K201491
Device Name	Neodent Implant System - Zirconia Implant System
Applicant	Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Product Code	DZE · Dental
Decision Date	Dec 22, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Device Story

Neodent Zirconia Implant System consists of endosseous dental implants, cover screws, healing abutments, and zirconia base abutments. Implants are apically tapered with trapezoidal threads and sand-blasted, acid-etched surfaces to promote osseointegration. The system uses a ZiLock internal connection for prosthetic interface. Zirconia base abutments are two-piece components (zirconia base bonded to CAD/CAM zirconia top) used to support patient-specific restorations like crowns or copings. Used by dentists/oral surgeons in clinical settings. The workflow involves surgical placement of the implant, followed by prosthetic design using CAD software (e.g., 3Shape, Dental Wings) and manufacturing at a validated milling center. The output is a customized prosthetic restoration that restores chewing function and aesthetics. Benefits include metal-free restoration options for patients with metal sensitivities and reliable mechanical performance for tooth replacement.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility (ISO 10993-1, 5, 12, 18), dynamic fatigue testing (ISO 14801), torsion testing, insertion torque evaluation in sawbones, and sterilization validation (ISO 11135-1). Shelf-life and packaging integrity (ISO 11607-1) were confirmed via accelerated aging. No clinical data provided.

Technological Characteristics

Materials: Y-TZP (Yttrium-stabilized zirconium dioxide) for implants/abutments; Titanium alloy (ASTM F136) for cover/basal screws. Design: Apically tapered, trapezoidal threads, ZiLock internal connection. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: Digital restorative workflow via CAD software. Single-use only.

Indications for Use

Indicated for patients requiring dental restoration via endosseous implants in the upper or lower jaw to support prosthetic devices (artificial teeth) for chewing function. Suitable for single or multiple unit restorations, single or two-stage surgical procedures, and immediate loading if primary stability is achieved. Contraindications include patients where standard dental implant procedures are not advised.

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

Neodent Implant System - CM Line (K101945)

Reference Devices

Neodent Implant System (K150367)
Z5c, Z-Systems AG (K132881)
Neodent Implant System (K153624)
Straumann PURE Ceramic Implant System (K180477)
MRI Compatibility For Existing Neodent Implant System (K182620)
Straumann Ceramic Healing Abutments (K192893)

Related Devices

K250271 — Neodent Implant System - Zirconia Implant System · JJGC Indústria e Comércio de Materiais Dentários S.A. · Aug 18, 2025
K231803 — Neodent Implant System - Zirconia Implant System · JJGC Indústria e Comércio de Materiais Dentários S.A. · Dec 13, 2023
K210336 — Neodent Implant System - Zirconia Implant System · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Aug 13, 2021
K153624 — Neodent Implant System · Jjgc Industria E Comercio DE Materiais Dentarios S · Apr 15, 2016
K150367 — Neodent Implant System · Jjgc Industria E Comercio DE Materiais Dentarios S · Jul 13, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810 Re: K201491 Trade/Device Name: Neodent Implant System - Zirconia Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 20, 2020 Received: November 23, 2020 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 aware 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201491 Device Name Neodent Implant System - Zirconia Implant System #### Indications for Use (Describe) Indications for Use for Zirconia Implants, Cover Screw and Healing Abutment: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with singlestage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. Type of Use (Select one or both, as applicable) | <div> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black" stroke-width="2"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| ## 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201491 Device Name Neodent Implant System - Zirconia Implant System Indications for Use (Describe) Indications for Use for Zirconia Bases: The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base 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) | |--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px; text-align: center;">X</div> | <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px; text-align: center;"></div> | ## 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." {4}------------------------------------------------ ## 510(k) Summary ## ADMINISTRATIVE INFORMATION | Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA (dba Neodent) Av. Juscelino Kubitschek de Oliveira, 3291 Curitiba, Parana, Brazil 81270-200 Registration No.: 3008261720 Owner/Operator No.: 10031702 | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Jennifer M. Jackson, MS Director of Regulatory Affairs, Straumann USA E-mail: jennifer.jackson@straumann.com Telephone (978) 747-2509 | | Date Prepared | 21/December/2020 | | Preparer / Alternate Contact | Mariana Soares Hartmann Regulatory Affairs Analyst JJGC Indústria e Comércio de Materiais Dentários SA E-mail: mariana.hartmann@neodent.com | | DEVICE NAME AND CLASSIFICATION | | | Trade/ Proprietary Name | Neodent Implant System – Zirconia Implant System | | Common Name | Endosseous dental implant Endosseous dental implant abutment | | Classification Name | Endosseous dental implant | | Classification Regulations | 21 CFR 872.3640, Class II | | Product Code | DZE / NHA | | Classification Panel | Dental Products Panel | | Reviewing Branch | Dental Devices Branch | | PREDICATE DEVICE INFORMATION | | | Primary Predicate Device | K101945 - Neodent Implant System - CM Line, JJGC Indústria e Comércio de Materiais Dentários S.A | | Reference Devices | K150367 - Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A | | | K132881 - Z5c, Z-Systems AG | | | K153624 - Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A | | | K180477 – Straumann PURE Ceramic Implant System, Institut Straumann AG | | | K182620 - MRI Compatibility For Existing Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A | | | K192893 - Straumann® Ceramic Healing Abutments, Institut Straumann AG | {5}------------------------------------------------ ### INDICATIONS FOR USE Indications for Use for Zirconia Implants, Cover Screw, and Healing Abutments: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple teeth applications can be rigidly splinted. ### Indications for Use for Zirconia Bases: The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. ## SUBJECT DEVICE DESCRIPTIONS - Intended for single use; - Zirconia implants provided sterile via Ethylene Oxide; Zirconia Base abutments are provided sterile but require end user sterilization via moist heat following cementation of the restoration and before use - All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide), except for the Zirconia Implant Cover Screw and the Basal Screw, which is manufactured of titanium alloy according to ASTM F136 standard; - ZiLock prosthetic interface with internal indexer; - Apically tapered implant with trapezoidal thread profile; - Implant provided with sand-blasted, acid etched surface finish to facilitate osseointegration. - The final finished Zirconia Base abutments are two-piece abutments composed of a zirconia base bottom-half bonded to a CAD-CAM zirconia top-half. {6}------------------------------------------------ ## TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLES #### Table 1. Technological Characteristic Comparison Table - Zirconia Implants, Cover Screws, and Healing Abutments | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | Equivalence Discussion | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | K201491 Neodent Implant System - Zirconia Implant System - Implants JJGC Indústria e Comércio de Materiais Dentários S.A. | K101945 Neodent Implant System Alvim Implants JJGC Indústria e Comércio de Materiais Dentários S.A. | K180477 Straumann PURE Ceramic Implant System Implants Institut Straumann AG | Identical The Indications for Use of the subject devices are the same as for the primary predicate devices. | | | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two- stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple teeth applications can be rigidly splinted. | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two- stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple teeth applications can be rigidly splinted | 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 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 Abutments: | | | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | Equivalence Discussion | | | K201491 Neodent Implant System - Zirconia Implant System - Implants JJGC Indústria e Comércio de Materiais Dentários S.A. | K101945 Neodent Implant System Alvim Implants JJGC Indústria e Comércio de Materiais Dentários S.A. | K180477 Straumann PURE Ceramic Implant System Implants Institut Straumann AG | | | | | | 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. | | | Implant- Abutment interface | Straight internal connection indexing features (Zilock) | CM Morse Taper | Straight internal connection indexing features (RD) | Equivalent Subject devices and reference devices present internal connection and are equipped with a rotational lock and an inner thread for fixation of the temporary components and final abutments. | | Design | Apically Tapered format Trapezoidal threads profile Bone compression capacity during installation | Apically Tapered format Trapezoidal threads profile | Straight cylindrical implant body | Equivalent The subject devices have the same apically-tapered shape and trapezoidal thread form as the primary predicate device. | | Reusable | No | No | No | Identical The subject devices and the primary predicate devices are indicated for single use. | | Length (mm) | 8; 10; 11.5; 13 | 8; 10; 11.5; 13; 16 | 8; 10; 12; 14 | Equivalent Range of lengths for subject devices is within the range of lengths for the primary predicate devices. | | Diameter (Ø) | 4.3 mm | 3.5; 4.3; 5.0 mm | Endosteal 4.1 mm | Equivalent | | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | | | | K201491 Neodent Implant System - Zirconia Implant System - Implants JJGC Indústria e Comércio de Materiais Dentários S.A. | K101945 Neodent Implant System Alvim Implants JJGC Indústria e Comércio de Materiais Dentários S.A. | K180477 Straumann PURE Ceramic Implant System Implants Institut Straumann AG | Equivalence Discussion | | (mm) | | | Platform 4.8 mm | Diameter of subject devices is within the range of diameters for the primary predicate devices. | | Material | Yttrium-stabilized zirconium dioxide (Y-TZP). | Commercially pure titanium (Grade 4) | Yttrium-stabilized zirconium dioxide (Y-TZP). | Equivalent The subject devices have the same material of construction as the identified reference devices. | | Sterilization Method | Provided sterile via Ethylene Oxide to an SAL of 10-6 | Provided sterile via Gamma irradiation to an SAL of 1x10-6 | Provided sterile via Ethylene Oxide to an SAL of 10-6 | Equivalent The subject devices and the primary predicate devices are provided in sterile condition to an SAL of 1 x 10-6. The subject devices use the same sterilization method as for the reference devices. | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ | SUBJECT DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | Equivalence Discussion | | SUBJECT DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | | | |----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K201491 Neodent Implant System - Zirconia Implant System JJGC Indústria e Comércio de Materiais Dentários S.A. | K180477 Straumann PURE Ceramic Implant System PUREbase Abutments Institut Straumann AG | K150367 Neodent Implant System Titanium Base Abutments JJGC Indústria e Comércio de Materiais Dentários S.A. | K132881 Z5c Z-Systems AG | | | K201491 Neodent Implant System - Zirconia Implant System JJGC Indústria e Comércio de Materiais Dentários S.A. | K180477 Straumann PURE Ceramic Implant System PUREbase Abutments Institut Straumann AG | K150367 Neodent Implant System Titanium Base Abutments JJGC Indústria e Comércio de Materiais Dentários S.A. | K132881 Z5c Z-Systems AG | Equivalence Discussion | | | Indications for Use | The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient- specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. | 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 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 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. | Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement- or screw-retained single or multi-unit restorations single. All digitally designed copings and/or crowns to be used with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. The GM Titanium Base for Bridge is indicated for cement or screw-retained multi-unit restorations | Z5c implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5c implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them. Z5c implants are intended for delayed loading. | Equivalent The Indications for the subject devices are equivalent to reference devices (K150367). Although the words are different, the content of the indications for use are similar. The primary predicate covers the indications for use of the reference devices. The indications for use of the subject devices are contained within the indications for use of the primary predicate devices. | Abutment Material | Zirconia Base: Yttrium- stabilized zirconium dioxide (Y-TZP). Screw: Titanium alloy Screw according to ASTM F136 standard. | Ti-6Al-7Nb | Titanium alloy according to ASTM F136 standard. | Yttrium-stabilized zirconium dioxide (Y-TZP). | Equivalent The subject devices and the reference devices (K132881) have the same material of construction. | | | SUBJECT DEVICE | REFERENCE DEVICE | REFERENCE DEVICE…