(206 days)
Indications for Use for NUVO IF Implants and conventional abutments:
The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or twostage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.
The Attachment Equator and Attachment Removable Prosthesis are indicated for the attachment of full or partial dentures to NUVO implants.
Indications for Use for Rotational and Anti-rotational Titanium Bases abutments:
Titanium Base Abutment is a titanium base placed onto 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 or screw-retained single restorations.
All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations.
Indications for Use for CARES® Abutment IF:
The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for cementretained single restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.
The NUVO IF Implant System consists of implants, cover screws, and abutments.
Implants: Intended for single use, provided sterile via gamma irradiation, manufactured of commercially pure titanium (Grade 4), bone level design, apically tapered thread-form with apical cutting flutes in various diameters and lengths, and provided with an internal hexagonal implant-to-abutment interface.
Cover Screws: Intended for single use, used to protect the internal geometry of the implants during healing, placed out of occlusion, provided sterile via gamma irradiation or ethylene oxide gas, manufactured of titanium alloy (Ti6Al4V-ELI), and provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants.
Abutments: Intended for single use, provided sterile via ethylene oxide gas or non-sterile, manufactured of titanium alloy (Ti6Al4V-ELI) or a combination of POM polymer and cobalt-chromium alloy, conical format available in different diameters, height of cementable area and gingival height, screw-retained to the implant, provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants, provided with coronal geometries in rotational (non-indexed) and anti-rotational (indexed) versions, and Titanium Base abutments are two-piece abutments composed of a titanium base and a patient-specific CAD/CAM top-half.
This looks like a 510(k) summary for a dental implant system (NUVO IF Implant System), not a study describing acceptance criteria and performance data for an AI/ML medical device. Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI device.
The document discusses:
- Trade/Device Name: NUVO IF Implant System
- Regulation Number/Name: 21 CFR 872.3640, Endosseous Dental Implant
- Regulatory Class: Class II
- Product Code: DZE, NHA
- Indications for Use: Surgical placement in maxilla or mandible for prosthetic device support, including immediate loading, temporary support, and attachment of dentures.
- Device Description: Details on implants (material, design, size, sterilization), cover screws (material, use, sterilization), and various abutment types (materials, design, sterilization, use).
- Predicate Devices: Several predicate devices are listed and compared for substantial equivalence.
- Performance Data: This section details non-AI/ML performance testing, including:
- Dynamic fatigue testing per ISO 14801.
- Sterilization validation (gamma irradiation per ISO 11137-1/2, ethylene oxide per ISO 11135, moist heat per ISO 17665-2).
- Ethylene oxide residuals testing per ISO 10993-7.
- Biological Safety Assessment per ISO 10993-1 (cytotoxicity per ISO 10993-5, chemical characterization per ISO 10993-18).
- Package transport integrity per ISTA 2A.
- Product and package stability per ASTM F1980.
- Product endotoxin testing (LAL) per ANSI/AAMI ST72.
There is no mention of an AI/human-in-the-loop study, ground truth establishment, sample sizes for training/test sets for AI, or expert adjudication.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it.
June 18, 2020
JJGC Indústria e Comércio de Materiais Dentários S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K193234
Trade/Device Name: NUVO IF Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 19, 2020 Received: May 20, 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.
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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 (QS) 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,
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193234
Device Name NUVO IF Implant System
Indications for Use (Describe)
Indications for Use for NUVO IF Implants and conventional abutments:
The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or twostage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.
The Attachment Equator and Attachment Removable Prosthesis are indicated for the attachment of full or partial dentures to NUVO implants.
Indications for Use for Rotational and Anti-rotational Titanium Bases abutments:
Titanium Base Abutment is a titanium base placed onto 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 or screw-retained single restorations.
All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations.
Indications for Use for CARES® Abutment IF:
The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for cementretained single restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing 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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510(k) Summary
K193234
| ADMINISTRATIVE INFORMATION | |
|---|---|
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA(dba Neodent)Av. Juscelino Kubitschek de Oliveira, 3291Curitiba, Parana, Brazil 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702 |
| Contact Person | Jennifer M. Jackson, MSDirector of Regulatory Affairs,Straumann USAE-mail: jennifer.jackson@straumann.comTelephone (978) 747-2509 |
| Date Prepared | 17 June 2020 |
| Preparer / Alternate Contact | Luiza Vaccari ToppelRegulatory Affairs CoordinatorJJGC Indústria e Comércio de Materiais Dentários SAE-mail: luiza.toppel@neodent.com |
DEVICE NAME AND CLASSIFICATION
| Trade/ Proprietary Name | NUVO IF Implant System |
|---|---|
| Common Name | Endosseous dental implant |
| Classification Name(s) | Endosseous dental implant |
| Classification Regulation(s) | 21 CFR 872.3640, Class II |
| Product Code(s) | DZE; NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
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PREDICATE DEVICE INFORMATION
| Primary Predicate Device | K101945 – Neodent Implant System, JJGC Indústria eComércio de Materiais Dentários SA |
|---|---|
| Reference Predicate Devices | K150203 – Medentika CAD/CAM Abuments, MedentikaGmbHK150367 – Neodent Implant System, JJGCK153624 – Neodent Implant System, JJGCK163194 – Neodent Implant System - GM Line, JJGCK173902 – Neodent Implant System - GM Line, JJGCK190040 – Straumann BLX Line Extension - NewAbutments, Institut Straumann AGK190718 – GM Zygomatic Implants, JJGCK191191 – Neodent Implant System - TemporaryAbutments, JJGCK192229 – Neodent Implant System – Neodent TitaniumBase for Bridge, JJGC |
INDICATIONS FOR USE
Indications for Use for NUVO IF Implants and conventional abutments:
The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order 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 tooth applications may be rigidly splinted.
The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.
The Attachment Equator and Attachment Removable Prosthesis abutments are indicated for the attachment of full or partial dentures to NUVO implants.
Indications for Use for Rotational and Anti-rotational Titanium Bases abutments:
Titanium Base Abutment is a titanium base placed onto 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-retained single or multi-unit restorations or screw-retained single restorations.
All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations.
Indications for Use for CARES® Abutment IF:
The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for screw-retained or cement-retained single restorations.
All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.
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SUBJECT DEVICE DESCRIPTIONS
Implants
- . Intended for single use;
- Provided sterile via gamma irradiation
- Manufactured of commercially pure titanium (Grade 4) per ASTM F67;
- Bone level design
- Apically tapered thread-form with apical cutting flutes in 3.5, 3.75 & 4.3 mm diameters with lengths of 7, 10, 11.5, 13, 16 & 18 mm and in 5.0 mm diameter with lengths of 7, 10, 11.5, 13 & 16 mm.
- Provided with an internal hexagonal implant-to-abutment interface compatible with the subject Cover Screw and Abutments.
Cover Screws
- Intended for single use;
- Used to protect the internal geometry of the subject Nuvo IF implants during the healing phase when a two-stage protocol is used;
- Placed out of occlusion;
- Provided sterile via gamma irradiation in the same barrier package as the subject implants—also provided individually packaged in sterile condition via ethylene oxide gas;
- Manufactured of titanium alloy (Ti6Al4V-ELI) per ASTM F136;
- Provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the subject Nuvo IF implants.
Abutments
- Intended for single use;
- Provided sterile via ethylene oxide gas or non-sterile
- Manufactured of titanium alloy (Ti6Al4V-ELI) per ASTM F136 or in a combination of POM (Polyoxymethylene) polymer and cobalt-chromium alloy (CoCr), conforming to ASTM F1537;
- Conical format available in different diameters, height of cementable area and gingival height;
- Screw-retained to the implant;
- Provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the subject Nuvo IF implants;
- Provided with coronal geometries in rotational (non-indexed) versions to support multiunit restorations and in anti-rotational (indexed) versions to support single restorations
- Titanium Base abutments are two-piece abutments which are composed of a titanium base and a patient-specific CAD/CAM top-half, that when assembled together form the final finished device.
SUBSTANTIAL EQUIVALENCE COMPARISON TABLES
The Substantial Equivalence Comparison tables are provided on the pages that follow below.
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| Table 1. Substantial Equivalence -- Indication for Use Statements | |||||||
|---|---|---|---|---|---|---|---|
| SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATES | |||||
| COMPARISON | K193234NUVO IF Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A. | K101945Neodent Implant System –CM Alvim Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A. | K150367Neodent Implant System –TiBase & PrefaceJJGC Indústria e Comércio deMateriais Dentários S.A. | K163194Neodent Implant System –GM LineJJGC Indústria e Comércio deMateriais Dentários S.A. | K192229Neodent Implant System –GM Titanium Base forBridgeJJGC Indústria e Comércio deMateriais Dentários S.A. | K191191Neodent Implant System –Temporary AbutmentsJJGC Indústria e Comércio deMateriais Dentários S.A. | K190040Straumann® PURElocabutmentsInstitut Straumann AG |
| Indicationsfor UseStatement | Indications for Use for NUVO IF Implantsand conventional abutments:The NUVO IF Implant System is intended tobe surgically placed in the maxilla ormandible to provide support for prostheticdevices such as artificial teeth in order torestore chewing function. It may be usedwith single-stage or two-stage procedures,for single or multiple unit restorations, andmay be loaded immediately when goodprimary stability is achieved and withappropriate occlusal loading. Multipletooth applications may be rigidly splinted.The Titanium Temporary Abutment isindicated to provide temporary support forprosthesis structure for up to 6 months.The Attachment Equator and AttachmentRemovable Prosthesis abutments areindicated for the attachment of full orpartial dentures to NUVO implants.Indications for Use for Rotational and Anti-rotational Titanium Bases abutments:Titanium Base Abutment is a titanium baseplaced onto dental implants to providesupport for customized prostheticrestorations. It is used with a coping andcrown, or crown alone, and is indicated forcement-retained single or multi-unitrestorations or screw-retained singlerestorations.All digitally designed copings and/orcrowns to be used with the Titanium BaseAbutment System are intended to be sent | The Neodent Implant Systemis intended to be surgicallyplaced in the bone of theupper or lower jaw toprovide support forprosthetic devices such asartificial teeth, to restorechewing function. It may beused with single-stage ortwo-stage procedures, forsingle or multiple unitrestorations, and may beloaded immediately whengood primary stability isachieved and withappropriate occlusal loading.Multiple tooth applicationsmay be rigidly splinted. | Titanium Base Abutment is atitanium base placed ontoNeodent dental implants toprovide support forcustomized prostheticrestorations. It is used with acoping and crown, or crownalone, and is indicated forcement-retained single ormulti-unit restorations, orscrew-retained singlerestorations.PreFace Abutment is atitanium abutment to be usedin fabricating a full customabutment and placed ontoNeodent dental implants toprovide support forcustomized prostheticrestorations.PreFace Abutments are indicated forscrew-retained singlerestorations or cement-retained single or multi-unitrestorations. | Indications for Use for GMimplants and conventionalabutments:The Neodent Implant Systemis intended to be surgicallyplaced in the bone of theupper or lower jaw toprovide support forprosthetic devices such asartificial teeth, to restorechewing function. It may beused with single-stage ortwo-stage procedures, forsingle or multiple unitrestorations, and may beloaded immediately whengood primary stability isachieved and withappropriate occlusal loading.Indications for Use for GMTitanium Base abutments:Titanium Base Abutment is atitanium base placed ontoNeodent dental implants toprovide support forcustomized prostheticrestorations. It is used with acoping and crown, or crownalone, and is indicated forcement-retained single ormulti-unit restorations, orscrew-retained singlerestorations.All digitally designed copingsand/or crowns for use withthe Neodent Titanium Base | Titanium Base Abutment is atitanium base placed ontoNeodent dental implants toprovide support forcustomized prostheticrestorations. It is used with acoping and crown, or crownalone, and is indicated forcement-retained single ormulti-unit restorations orscrew-retained singlerestorations.All digitally designed copingsand/or crowns to be used with theNeodent Titanium BaseAbutment System areintended to be sent toStraumann for manufactureat a validated milling center.The GM Titanium Base forBridge is indicated forcement or screw-retainedmulti-unit restorations. | The Neodent Implant Systemis intended to be surgicallyplaced in the bone of theupper or lower jaw toprovide support forprosthetic devices such asartificial teeth, to restorechewing function. It may beused with single-stage ortwo-stage procedures, forsingle or multiple unitrestorations, and may beloaded immediately whengood primary stability isachieved and withappropriate occlusal loading.The Neodent Implant System- Temporary Abutments areindicated to be used onNeodent implants to providetemporary support forprosthesis structure for up to6 months. | The Straumann®Retentive System isindicated for theattachment of full orpartial dentures onStraumann implants |
| SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATES | |||||
| COMPARISON | K193234NUVO IF Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A. | K101945Neodent Implant System -CM Alvim Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A. | K150367Neodent Implant System -TiBase & PrefaceJJGC Indústria e Comércio deMateriais Dentários S.A. | K163194Neodent Implant System -GM LineJJGC Indústria e Comércio deMateriais Dentários S.A. | K192229Neodent Implant System -GM Titanium Base forBridgeJJGC Indústria e Comércio deMateriais Dentários S.A. | K191191Neodent Implant System -Temporary AbutmentsJJGC Indústria e Comércio deMateriais Dentários S.A. | K190040Straumann® PURElocabutmentsInstitut Straumann AG |
| validated milling center.The Rotational Titanium Base is indicatedfor cement or screw-retained multi-unitrestorations.Indications for Use for CARES® AbutmentIF:The CARES® Abutment is a customizedprosthetic abutment, manufactured intitanium alloy, placed onto dental implantsto provide support for customizedprosthetic restorations (copings or crowns).It is indicated for screw-retained orcement-retained single restorations.All digitally designed abutments for usewith the CARES® Abutment are intended tobe sent to Straumann for manufacturing at | intended to be sent toStraumann for manufactureat a validated milling center.Indications for Use for GMPro Peek Abutments:The Pro PEEK Abutments areindicated to be used onNeodent implants to providetemporary support forprosthesis structure for up to6 months. They can be used inone or two stage proceduresand also immediate load whenthere is good primary stability. |
Table 1: Substantial Equivalence – Indication for Use Statements
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The scope of the Indications for Use Statement for the subject devices (implants and conventional abutments section) are contained within the corresponding section of the Indications for Use Statement of the primary predicate device K101945. The specific languages for Titanium Temporary Abutment and Attachment Equator/Attachment Removable Prosthesis are the same of the corresponding section of the Indications for Use Statement of K191191 (Neodent Implant System - Temporary Abutments) and K190040 (Straumann® PUREloc abutments), except for the names of the devices.
The Indications for Use Statement for the subject device (Rotational and Anti-rotational Titanium Bases abutments section) is identical to the corresponding section of the Indications for Use Statement of K163194 (GM Titanium Base abutments section), except for the names of the devices. The specific indication for use for Titanium Base Rotational is the same of K192229 (Neodent Implant System - GM Titanium Base for Bridge).
The Indications for Use Statement for the subject device (CARES® Abutment IF section) is similar to the PreFace section of the Indications for Use Statement of the reference device K150367. The slight differences are the names of the devices and, for the subject device statement, the requirement to manufacture at a Straumann milling center. For K150367 the requirement to manufacture at a Straumann milling center was included in the labeling. The slight differences in wording between the Indications for Use Statements for the subject device and the reference device K150367 do not affect the intended use with dental implants for rehabilitation of the edentulous maxilla or mandible.
A comparison of the technological characteristics of the subject device and the predicate and reference devices is provided in the following table.
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Table 2: Substantial Equivalence Comparison – Technological characteristics - Implants
| SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATE | ||
|---|---|---|---|---|
| K193234 | K101945 | K163194 | ||
| COMPARISON | NUVO IF Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A. | Neodent Implant System - CM LineJJGC Indústria e Comércio de MateriaisDentários S.A. | Neodent Implant System - GM LineJJGC Indústria e Comércio de MateriaisDentários S.A. | EQUIVALENCE DISCUSSION |
| Implant Type | Bone Level | Bone Level | SameThe subject devices have the same externaldesign as the primary predicate. | |
| Implant-to-AbutmentInterface | Internal Hex | Cone Morse | EquivalentThe implant interface is equivalent to that ofthe predicate. Dynamic fatigue testing hasbeen performed to establish the performanceof the interface. | |
| ImplantDiameter | 3.5 mm, 3.75 mm, 4.3 mm and 5.0 mm | 3.5 mm, 4.3 mm and 5.0 mm | 3.5 to 5.0 mm | EquivalentThe subject device diameters are in the rangeof diameters of the primary and referencepredicate devices. |
| Implant Length | 3.5 mm: 7, 10, 11.5, 13, 16 & 18 mm3.75 mm: 7, 10, 11.5, 13, 16 & 18 mm4.3 mm: 7, 10, 11.5, 13, 16 & 18 mm5.0 mm: 7, 10, 11.5, 13 & 16 mm | Alvim CM ImplantAll diameters: 8, 10, 11.5, 13 & 16 mmTitamax CM Implant3.5 mm: 7, 8, 9, 11, 12, 15 & 17mm3.75 mm: 7, 8, 9, 11, 12, 15 & 17mm4.0 mm: 7, 8, 9, 11, 12, 15 & 17mm5.0 mm: 7, 8, 9, 11, 12, 15 & 17mm | 8 to 18 mm | EquivalentThe subject device lengths are within the rangeestablished by the primary and referencepredicate devices. |
| Thread Design | Apically Tapered, Dual Helix | Apically Tapered, Dual Helix(Trade Name = Alvim) | Same | |
| Surface Finish | Sand blasted and acid etched | Sand blasted and acid etched(Trade Name = Neoporos) | Same | |
| Material | Commercially Pure Titanium (Grade 4) | Commercially Pure Titanium (Grade 4) | Same | |
| Single Use | Yes | Yes | Same | |
| SterilizationMethod | Gamma Irradiation to an SAL of 1x10-6 | Gamma Irradiation to an SAL of 1x10-6 | Same | |
| EQUIVALENCE DISCUSSION | ||||
| COMPARISON | SUBJECT DEVICES | PRIMARY PREDICATE | ||
| K193234 | K101945 | |||
| NUVO IF Implant System | Neodent Implant System - CM Alvim Implant System | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | JJGC Indústria e Comércio de Materiais Dentários S.A. | |||
| Cover Screw/Healing Abutment | ||||
| Principal of operation | Screw used to protect internal features of the implantduring submerged healing protocol and to define gingivashape during delayed loading protocols. | Conditioning the soft tissues and closing the implantinterface during healing phase. | EquivalentThe principal of operation of subject device is equivalent ofthe primary and reference predicate device. | |
| Implant-to-AbutmentInterface | Internal Hex | Cone Morse | EquivalentThe implant interface is equivalent to that of the predicate. | |
| Diameter | Cover Screw Platform Ø:NP - 3.5 mm SP - 4.5 mm | Conventional abutments:3.5 to 4.5 mm | EquivalentSubject device diameters are within the range of diametersof the predicate devices or larger. Larger diameters do notrepresent a worst case in terms of performance. | |
| Healing Abutment Platform Ø:NP - 3.5 mm SP - 4.5 mm and 5.5 mm | ||||
| Gingival Height | 1.0, 3.0 and 5.0 mm | 0.8 to 6.5 mm | EquivalentSubject device heights are included in the range of thepredicate device heights. | |
| Angulation | Straight | Straight | Same | |
| Material | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Same | |
| Surface Treatment | Machined and anodized (only NP platform) | Machined and anodized | Same | |
| Single Use | Yes | Yes | Same | |
| Sterilization Method | Co-packaged implant and cover screw Gamma Irradiation toan SAL of 1x10-6 | Ethylene Oxide to an SAL of 1x10-6 | EquivalentThe subject device when provided co-packaged with theimplant share the same sterilization method and minimumSAL of the reference predicate device. | |
| Cover screw and Healing provided individuallyEthylene Oxide to an SAL of 1x10-6 | The subject devices when provided individually share thesame sterilization method and minimum SAL of the primarypredicate device. | |||
| Multi-Unit Abutment | ||||
| Principal of operation | Abutment designed to accept a screw-retainedprosthetic. | To support final restorations when placed on implants. | EquivalentThe principal of operation of subject device is equivalent ofthe primary and reference predicate device. | |
| Implant-to-AbutmentInterface | Internal Hex | Cone Morse | EquivalentThe implant interface is equivalent to that of the predicate. | |
| SUBJECT DEVICES | PRIMARY PREDICATE | EQUIVALENCE DISCUSSION | ||
| COMPARISON | K193234NUVO IF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. | K101945Neodent Implant System - CM Alvim Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. | ||
| Indexing | Indexed (angled abutments) and non-indexed (straight abutments) | Indexed (angled abutments) and non-indexed (straight abutments) | Same | |
| Diameter | Platform Ø:NP – 3.5 & 4.8 mmSP – 4.8 mm | Platform Ø: 3.5 mm, 4.5 mm | EquivalentSubject device diameters are within the range of diametersof the predicate devices or larger. Larger diameters do notrepresent a worst case in terms of performance. | |
| Gingival Height | NP – 0.5, 1, 2, 2.3, 3, 4 & 5 mmSP – 1, 2, 2.3, 3, 4 & 5 mm | Straight: 0.8 to 6.5 mmAngled: 1.5 to 3.5 mm | EquivalentSubject devices are included in the range of the predicatedevice gingival heights or higher.Higher gingival height do not represent a worst case in termsof performance. | |
| Angulation | 0°, 17° & 30° | 0°, 17° & 30° | Same | |
| Material | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Same | |
| Surface Treatment | Machined and anodized (only NP platform) | Machined | EquivalentAnodized surface treatment is presented in other abutmentsof K101945. | |
| Single Use | Yes | Yes | Same | |
| Sterilization Method | Ethylene Oxide to an SAL of 1x10-6 | Ethylene Oxide to an SAL of 1x10-6 | Same | |
| Principal of operation | Abutment designed to accept a cement-retained prosthetic.Customizable Cement Retained Abutment designed to accept a cement-retained prosthetic. Features to facilitatetrimming height of coronal geometry from 6 mm down to a minimum of 4 mm. | To support final restorations when placed on implants. | EquivalentThe principal of operation of subject device is within of theprimary predicate device.These devices are equivalent in design to the subject straightCement-Retained Abutments described above. The ability tomodify the abutment height does not affect the intendeduse. The length of the combination of the abutment and thecemented prosthesis will be equivalent to the straightCement-Retained Abutments. | |
| Implant-to-AbutmentInterface | Internal Hex | Cone Morse | EquivalentThe implant interface is equivalent to that of the predicate. | |
| Indexing | Indexed | Both Indexed and Non-indexed | Same | |
| Diameter | Platform Ø:NP – 3.5 mmSP – 4.5 mm | Platform Ø: 3.5 mm, 4.5 mm | Same | |
| SUBJECT DEVICES | PRIMARY PREDICATE | |||
| COMPARISON | K193234 | K101945 | EQUIVALENCE DISCUSSION | |
| NUVO IF Implant System | Neodent Implant System - CM Alvim Implant System | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | JJGC Indústria e Comércio de Materiais Dentários S.A. | |||
| Gingival Height | Straight - 0.5, 1. 2, 1.5 & 3 mm17° - 1.5 & 3 mm25° - 2 & 3 mm | Straight - 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 & 6.5 mmAngled - 1.5, 2.5 & 3.5 mm | EquivalentSubject device are included in the range of the predicatedevice gingival heights. | |
| Angulation | 0°, 17° & 25° | 0°, 17° & 30° | EquivalentThe subject devices are included in the range of the predicatedevice angulation. | |
| Material | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Same | |
| Surface Treatment | Machined and anodized (only NP platform) | Machined | EquivalentAnodized surface treatment is presented in other abutmentsof K101945. | |
| Single Use | Yes | Yes | Same | |
| Sterilization Method | Ethylene Oxide to an SAL of 1x10-6 | Ethylene Oxide to an SAL of 1x10-6 | Same |
{10}------------------------------------------------
Table 3: Substantial Equivalence Comparison – Traditional Abutments (Cover Screw/Healing Abutment/Multi-Unit Abutnent/Cement Retained Abutment)
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{12}------------------------------------------------
{13}------------------------------------------------
Table 4: Substantial Equivalence Comparison – Technological characteristics – Traditional Abutments)
| SUBJECT DEVICES | REFERENCE PREDICATE | EQUIVALENCE DISCUSSION | SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATES | ||||
|---|---|---|---|---|---|---|---|---|---|
| K193234 | K191191 | COMPARISON | K193234NUVO IF Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A. | K101945Neodent Implant System - CMAlvim Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A. | K173902Neodent Implant System - GM LineJJGC Indústria e Comércio deMateriais Dentários S.A. | K190040Straumann BLX Line Extension -New AbutmentsInstitut Straumann AG | EQUIVALENCE DISCUSSION | ||
| COMPARISON | NUVO IF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. | Neodent Implant System - Temporary AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A. | Equator Attachment | Equator Attachment IF | CM Mini Ball Attachment | GM Attachment Equator | Novaloc Abutments | ||
| Titanium Temporary | Titanium Temporary Abutment for Crown and forBridge | GM Temporary Abutment | Principal of operation | Abutment to accept detachableover-denture prostheses.Coronal Geometry: To accepto-ring style matrices | Abutment to accept detachableover-denture prostheses.Coronal Geometry: To accepto-ring style matrices | Abutment to accept detachableover-denture prostheses.Coronal Geometry: To accept o-ring style matrices | SameThe principal of operation ofsubject device is the same of theprimary predicate device. | ||
| Principal of operation | Abutment for the creation of a temporary, non-occlusalrestoration to address esthetics during fabrication of finalprosthesis. | Abutment for the creation of a temporary, non-occlusalrestoration to address esthetics during fabrication of finalprosthesis. | SameThe principal of operation of subject device is the same ofthe primary predicate device. | Implant-to-AbutmentInterface | Internal Hex | Cone Morse | Cone Morse | EquivalentThe implant-to-abutment interfaceis equivalent to that of thereference predicate. Dynamicfatigue testing is provided tosupport the performance of thesubject Internal Hex interface. | |
| Implant-to-AbutmentInterface | Internal Hex | Cone Morse | EquivalentThe implant interface is equivalent to that of the predicate. | Indexing | Non-indexed | Non-indexed | Non-indexed | Same | |
| Indexing | Both Indexed and Non-indexed | Both Indexed and Non-indexed | Same | Diameter | Platform Ø: NP - 3.5 mmSP - 4.5 | Not Defined | Platform Ø: 3.5 to 5.0 mm | EquivalentSubject devices are within therange of reference predicatedevices diameters. | |
| Diameter | Platform Ø:NP – 3.5 mmSP - 4.5 & 5.5 mm | Platform Ø: 3.5 mm, 4.5 mm | EquivalentSubject device diameters are within the range of diametersof the predicate devices or larger. Larger diameters do notrepresent a worst case in terms of performance. | Gingival Height | NP – 1, 2, 3, 4 & 5 mmSP – 1, 2, 3, 4 & 5 mm | 1.5, 2.5, 3.5, 4.5 & 5.5 mm | 1.5, 2.5, 3.5, 4.5 & 5.5 mm | EquivalentSubject devices are included in therange of the predicate devicesgingival heights. | |
| Gingival Height | 1.0 mm | 0.8; 1.5; 2.5 and 3.5 mm | EquivalentSubject device are included in the range of the predicatedevice gingival heights. | Angulation | Straight | Straight | Straight | Same | |
| Angulation | Straight | Straight | Same | Material | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Same | |
| Material | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Same | Surface Treatment | Machined with titanium nitridecoating | Machined | Machined with titanium nitridecoating | EquivalentSubject devices and referencepredicate devices have the samesurface treatment | |
| Surface Treatment | Machined (SP platform)Machined and anodized (NP platform) | Machined | EquivalentAnodized surface treatment is presented in other abutmentsof primary predicate device K101945. | Single Use | Yes | Yes | Yes | Same | |
| Duration of Use | Up to 6 months | Up to 6 months | Same | Sterilization Method | Ethylene Oxide to an SAL of1×10-6 | Ethylene Oxide to an SAL of 1x10-6 | Ethylene Oxide to an SAL of 1x10-6 | Same | |
| Single Use | Yes | Yes | Same | ||||||
| Sterilization Method | Ethylene Oxide to an SAL of 1x10-6 | Ethylene Oxide to an SAL of 1x10-6 | Same |
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Table 5: Substantial Equivalence Comparison – Traditional Abutnents (Equator Attachment and Removable Prosthesis Attachment)
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| SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATES | EQUIVALENCE DISCUSSION | ||
|---|---|---|---|---|---|
| COMPARISON | K193234NUVO IF Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A. | K101945Neodent Implant System – CMAlvim Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A. | K173902Neodent Implant System - GM LineJJGC Indústria e Comércio deMateriais Dentários S.A. | K190040Straumann BLX Line Extension -New AbutmentsInstitut Straumann AG | |
| Removable ProsthesisAttachment | Removable ProsthesisAttachment IF | CM Mini Ball Attachment | GM Attachment Equator | Novaloc Abutments | |
| Principal of operation | Abutment to accept detachableover-denture prostheses. | Abutment to accept detachableover-denture prostheses. | Abutment to accept detachableover-denture prostheses. | Abutment to accept detachableover-denture prostheses. | SameThe principal of operation of subjectdevice is the same of the primarypredicate device. |
| Design | Coronal Geometry: To acceptValoc Novaloc matrices | Coronal Geometry: To accept o-ring style matrices | Coronal Geometry: To accept o-ring style matrices | Coronal Geometry: To acceptValoc Novaloc matrices | EquivalentSubject devices and referencepredicates per K190040 have sameintended use and similar coronalgeometry (differing gingival heightsare not significant to performance). |
| Implant-to-AbutmentInterface | Internal Hex | Cone Morse | Cone Morse | Straumann BLX | EquivalentThe implant interface is equivalentto that of the predicate. |
| Indexing | Non-indexed | Non-indexed | Non-indexed | Indexed | Same |
| Diameter | Platform Ø: NP - 3.5 mmSP - 4.5 | Not Defined | Platform Ø: 3.5 to 5.0 mm | 4.5 mm | EquivalentSubject devices are within the rangeof reference predicate devicesdiameters. |
| Gingival Height | NP - 1, 2, 3, 4 & 5 mmSP - 1, 2, 3, 4 & 5 mm | 1.5, 2.5, 3.5, 4.5 & 5.5 mm | 1.5, 2.5, 3.5 ,4.5 & 5.5mm | 1.5 to 6.5 mm | EquivalentSubject devices are included in therange of the predicate devicesgingival heights. |
| Angulation | Straight | Straight | Straight | Straight and Angulated | Same |
| Material | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Same |
| Surface Treatment | Machined and titanium nitridecoating | Machined and titanium nitridecoating | Machined and titanium nitridecoating | Machined and titanium nitridecoating | EquivalentSubject devices and referencepredicate devices have the samesurface treatment |
| Single Use | Yes | Yes | Yes | Yes | Same |
| COMPARISON | SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATES | EQUIVALENCE DISCUSSION | |
| K193234NUVO IF Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A. | K101945Neodent Implant System – CMAlvim Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A. | K173902Neodent Implant System - GM LineJJGC Indústria e Comércio deMateriais Dentários S.A. | K190040Straumann BLX Line Extension -New AbutmentsInstitut Straumann AG | ||
| Sterilization Method | Ethylene Oxide to an SAL of$1 \times 10^{-6}$ | Ethylene Oxide to an SAL of $1 \times 10^{-6}$ | Ethylene Oxide to an SAL of $1 \times 10^{-6}$ | Non-Sterile | Same |
| SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATE | |||
| COMPARISON | K193234NUVO IF Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A. | K101945Neodent Implant System - CM AlvimImplant SystemJJGC Indústria e Comércio de MateriaisDentários S.A. | K173902Neodent Implant System - GM LineJJGC Indústria e Comércio de MateriaisDentários S.A. | EQUIVALENCE DISCUSSION | |
| UCLA CoCr | UCLA CoCr IF | Not applicable | GM Exact Co-Cr Abutment for Crown | ||
| Principal of operation | Abutment to facilitate the casting of basemetal and precious metal alloy prostheses. | Abutment to facilitate the casting of basemetal and precious metal alloy prostheses. | SameThe principal of operation of subject deviceis the same of the reference predicatedevice. | ||
| Implant-to-AbutmentInterface | Internal Hex | Cone Morse | Cone Morse | EquivalentThe implant interface is equivalent to that ofthe predicate. | |
| Indexing | Both Indexed and Non-indexed | Non-indexed | EquivalentThe subject devices indexing is theequivalent of reference predicate devices.The indexed devices are presented in otherprimary predicate devices. | ||
| Diameter | Platform Ø: NP – 3.5 mmSP - 4.5 & 5.5 mm | Platform Ø: 3.5 to 6.0 mm | EquivalentSubject devices are within the range ofreference predicate devices diameters. | ||
| Gingival Height | NP - 1, 2, 3, 4 & 5 mmSP - 1, 2, 3, 4 & 5 mm | 1 mm | EquivalentThe different gingival heights do notintroduce a new worst in terms ofperformance. | ||
| Angulation | Straight | Straight | SameThe subject devices and the predicatedevices are straight. | ||
| Material | CoCr Alloy with POM polymer | CoCr Alloy with POM polymer | SameSubject, primary and reference predicatedevices have the same material ofconstruction. | ||
| Surface Treatment | Machined and anodized (only NPplatform) | Machined | SameAnodized surface treatment is presented inother abutments of primary predicate deviceK101945. | ||
| Single Use | Yes | Yes | Yes | Same | |
| SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATE | |||
| COMPARISON | K193234NUVO IF Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A. | K101945Neodent Implant System – CM AlvimImplant SystemJJGC Indústria e Comércio de MateriaisDentários S.A. | K173902Neodent Implant System - GM LineJJGC Indústria e Comércio de MateriaisDentários S.A. | EQUIVALENCE DISCUSSION | |
| Sterilization Method | Provided non-sterile. Terminally sterilized bythe user via moist heat. Moist heat cycleparameters have been validated to an SAL of$1 x 10^{-6}$ . | Provided non-sterile. Terminally sterilized bythe user via moist heat. Moist heat cycleparameters have been validated to an SAL of$1 x 10^{-6}$ . | SameSubject and reference predicate deviceutilize the same sterilization method andminimum SAL. |
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Table 6: Substantial Equivalence Comparison – Technological characteristics – Traditional Abutments (UCLA CoCr)
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Table 7: Substantial Equivalence Comparison – CADCAM Abutments (Anti-Rotational Titanium Base IF)
| SUBJECT DEVICES | REFERENCE PREDICATES | |||
|---|---|---|---|---|
| COMPARISON | K193234NUVO IF Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A. | K150367 & K153624Neodent Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A. | K163194Neodent Implant System - GM LineJJGC Indústria e Comércio de MateriaisDentários S.A. | EQUIVALENCE DISCUSSION |
| Anti-RotationalTitanium Base IF | Anti-Rotational Titanium Base IF | Titanium Base Abutment | GM Exact Titanium Base | |
| Principal ofoperation | Abutment designed to accept a cement-retained prosthetic.Titanium Base abutments are two-pieceabutments which are composed of atitanium base and a patient-specificCAD/CAM top-half, that when assembled | Abutment designed to accept a cement-retained single or multi-unit restorations, orscrew-retained single restorations.Titanium Base abutments as two-pieceabutments which are composed of a titaniumbase and a patient-specific CAD/CAM top- | Screw-retained single-unit, or Cement-retained single or multi-unit.Titanium Base abutments as two-pieceabutments which are composed of a titaniumbase and a patient-specific CAD/CAM top-half, that when assembled together form the | EquivalentThe principal of operation of subject deviceis within the reference predicate devices. |
| together form the final finished device. | half, that when assembled together form thefinal finished device. | final finished device. | ||
| Implant-to-Abutment Interface | Internal Hex | Cone Morse | Cone Morse | EquivalentThe implant interface is equivalent to that ofthe predicate. |
| Indexing | Indexed | Indexed | Indexed | Same |
| Diameter | Platform Ø: NP - 3.5SP - 4.5 & 5.5 mm | Platform Ø: 3.5 mm, 4.5 mm | Platform Ø: 5.5 mm | EquivalentSubject device diameters are within the rangeof diameters of the predicate devices. |
| Gingival Height | NP - 0.5, 1 & 3 mmSP - 0.5, 1 & 3 mm | 0.8, 1.5, 2.5, 3.5 & 4.5 mm | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm | EquivalentSubject devices are included in the range ofthe predicate device gingival heights. |
| Angulation | Straight | Straight | Straight | Same |
| CAD/CAMRestorationAngulation | Up to 30° | Up to 30° | Up to 30° | Same |
| CAM/CAM Materialsuperstructure | IPS e.max CADCoron (CoCr)Zerion LT | IPS e.max CADCobalt-chromiumZirconia | IPS e.max CADCobalt-chromiumZirconia | EquivalentThe top-half material indicated for subjectdevice and reference predicate device are thesame. |
| Abutment Material | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Same |
| SUBJECT DEVICES | REFERENCE PREDICATES | |||
| K193234 | K150367 & K153624 | K163194 | ||
| COMPARISON | NUVO IF Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A. | Neodent Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A. | Neodent Implant System - GM LineJJGC Indústria e Comércio de MateriaisDentários S.A. | EQUIVALENCE DISCUSSION |
| Surface Treatment | Machined (SP platform)Machined and anodized (NP platform) | Machined | EquivalentAnodized surface treatment is presented inother abutments of K101945. | |
| Single Use | Yes | Yes | Yes | Same |
| Sterilization Method | Ethylene Oxide to an SAL of 1x10-6 | Ethylene Oxide to an SAL of 1x10-6 | Ethylene Oxide to an SAL of 1x10-6 | Same |
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Table 8: Substantial Equivalence Comparison – CADCAM Abutments (Rotational Titanium Base IF)
| COMPARISON | SUBJECT DEVICES | REFERENCE PREDICATE | EQUIVALENCE DISCUSSION |
|---|---|---|---|
| K193234 | K192229 | ||
| NUVO IF Implant System | Neodent Implant System - GM Titanium Base for Bridge | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | JJGC Indústria e Comércio de Materiais Dentários S.A. | ||
| Rotational TitaniumBase IF | Rotational Titanium Base IF | GM Titanium Base for Bridge | |
| Principal ofoperation | Abutment designed to accept a cement or screw-retainedprosthetic. | Abutment designed to accept a cement or screw-retainedprosthetic. | Same |
| Titanium Base abutments as two-piece abutments whichare composed of a titanium base and a patient-specificCAD/CAM top-half, that when assembled together formthe final finished device. | Titanium Base abutments as two-piece abutments which arecomposed of a titanium base and a patient-specific CAD/CAMtop-half, that when assembled together form the finalfinished device. | ||
| Implant-to-Abutment Interface | Internal Hex | Cone Morse | EquivalentThe implant interface is equivalent to that of the predicate. |
| Indexing | Non-Indexed | Non-Indexed | Same |
| Diameter | Platform Ø: NP – 3.5SP – 4.5 & 5.5 mm | Platform Ø: 3.5, 4.5, and 5.5 mm | EquivalentSubject device diameters are within the range of diameters ofthe predicate devices or larger. Larger diameters do notrepresent a worst case in terms of performance. |
| Gingival Height | NP – 0.5, 1 & 3 mmSP – 0.5, 1 & 3 mm | 0.8, 1.5, 2.5, 3.5 & 4.5 mm | EquivalentSubject devices are included in the range of the predicatedevice gingival heights. |
| Angulation | Straight | Straight | Same |
| CAD/CAMRestorationAngulation | Up to 30° | Up to 30° | Same |
| CAM/CAM materialsuperstructure | Titanium (brand name (ticon) | Titanium (brand name ticon) | Same |
| Cobalt-chromium (brand name coron) | Cobalt-chromium (brand name coron) | ||
| Zirconia (brand name zerion LT) | Zirconia (brand name zerion LT) | ||
| Abutment Material | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Same |
| Surface Treatment | Machined and anodized (only NP platform) | Machined | EquivalentAnodized surface treatment is presented in other abutmentsof K101945. |
| Single Use | Yes | Yes | Same |
| COMPARISON | SUBJECT DEVICES | EQUIVALENCE DISCUSSION | |
| K193234NUVO IF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. | K192229Neodent Implant System – GM Titanium Base for BridgeJJGC Indústria e Comércio de Materiais Dentários S.A. | ||
| Sterilization Method | Ethylene Oxide to an SAL of 1x10-6 | Ethylene Oxide to an SAL of 1x10-6 | Same |
| SUBJECT DEVICES | REFERENCE PREDICATE | ||
| COMPARISON | K193234 | K150367 | EQUIVALENCE DISCUSSION |
| NUVO IF Implant System | Neodent Implant System - Titanium Base & Preface | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | JJGC Indústria e Comércio de Materiais Dentários S.A. | ||
| CARES® Abutment | CARES® Abutment IF | PreFace Abutment | |
| IF | |||
| Principal of | Milling blank with the Implant-to-Abutment interface pre-milled at one end. Used to fabricate patient-specificabutments that are indicated with screw-retained orcement-retained single restorations | Milling blank with the Implant-to-Abutment interface pre-milled at one end. Used to fabricate patient-specificabutments that are indicated with screw-retained singlerestorations or cement-retained single or multi-unitrestorations. | EquivalentThe principal of operation of subject device is with thereference predicate device. |
| operation | |||
| Implant-to- | Internal Hex | Cone Morse | EquivalentThe implant interface is equivalent to that of the predicate. |
| Abutment Interface | |||
| Indexing | Indexed | Indexed | Same |
| Diameter | Oversize cylinder for milling 11.5 mm & 15.8 mmdiametersPlatform Ø: NP - 3.5SP - 4.5 | Oversize cylinder for milling 11.5 mm & 15.8 mmdiametersPlatform Ø: Not defined | Same |
| Gingival Height | NP - 0.5, 1 & 3 mmSP - 0.5, 1 & 3 mm | 0.8, 1.5, 2.5, 3.5 & 4.5 mm | EquivalentSubject devices are included in the range of the predicatedevice gingival heights. |
| Angulation | Straight | Straight | Same |
| Angulation of milled abutment: up to 30° | Angulation of milled abutment: up to 30° | ||
| Abutment Material | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Same |
| Surface Treatment | Machined (SP platform)Machined and anodized (NP platform) | Machined | EquivalentAnodized surface treatment is presented in other abutmentof K101945. |
| Single Use | Yes | Yes | Same |
| Sterilization | Provided Non-Sterile | Provided Non-Sterile | Same |
| Method | Terminally sterilized by user via moist steam viaparameters validated to an SAL of 1x10-6 | Terminally sterilized by user via moist steam via parametersvalidated to an SAL of 1x10-6 | Same |
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Table 9: Substantial Equivalence Comparison – CADCAM Abutments (CARES® Abutment IF)
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PERFORMANCE DATA
Dynamic fatigue test per ISO 14801 and FDA guidance entitled Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, issued on: May 12, 2004, was performed to determine the fatigue strength for the worst-case constructs assembled using the subject devices.
Sterilization of the subject endosseous dental implant devices via gamma irradiation was validated per ISO 11137-1 and ISO 11137-2.
A minimum Sterility Assurance Level (SAL) of 1 x 10 ° has been validated.
Sterilization of the subject abutments via ethylene oxide gas was validated per ISO 11135. A minimum Sterility Assurance Level (SAL) of 1 x 10 ° has been validated.
Ethylene oxide residuals have been assessed per ISO 10993-7. Residuals are within accepted limits.
Sterilization of the subject abutments via moist heat was validated per ISO 17665-2. A minimum Sterility Assurance Level (SAL) of 1 x 10-6 has been validated.
Biological Safety Assessment guided by ISO 10993-1 and FDA guidance entitled Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff, issued June 16, 2016. Reference to previous biocompatibility testing is supplied as follows:
- -Cytotoxicity testing was performed per ISO 10993-5.
- -Chemical characterization was performed per ISO 10993-18.
Package transport integrity testing has been performed per ISTA 2A.
Product and package stability has been validated per ASTM F1980.
Product endotoxin testing (LAL) is performed monthly on products representative of the subject devices per ANSI/AAMI ST72.
CONCLUSION
The subject devices and the identified primary and reference predicate devices have intended use, similar designs and technological characteristics same sterilization methods and are made of the same materials. The data included in this submission demonstrate that the subject devices are substantially equivalent to the identified predicate devices.
§ 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.