InterActive/SwishActive Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. These implants are also indicated for multiple tooth replacements or denture stabilization.

Compatibility: InterActive and SwishActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants.

Device Description

The 2014 InterActive/SwishActive System is a line extension of the previously cleared Implant Direct Sybron Manufacturing LLC, InterActive/SwishPlus2 Implant System (510K #130572) on December 24th, 2013). The name of the SwishPlus2 implants is changing to SwishActive and the Indications for Use within this submission has been revised from previous submission to only reflect the name change.

In addition, the previously cleared InterActive/SwishActive implants have been tested with NobelActive titanium 30 degree angled abutments to expand the indication for use as the test results show that the InterActive/SwishActive implants are prosthetically compatible with NobelActive NP (Narrow Platform -3.0mm diameter) and NobelActive RP (Regular Platform - 3.4mm diameter) titanium abutments with up to 30 degree angulations.

Furthermore, the InterActive 30 degree abutments have been tested with NobelActive implants to expand the indication for use as the test results show that the InterActive abutments are prosthetically compatible with NobelActive NP (Narrow Platform - 3.0mm diameter) and NobelActive RP (Regular Platform -3.4mm diameter) implants with up to 30 degree angulations.

Lastly, the 2014 InterActive/SwishActive System within this submission offers additional abutments that are intended to provide extra prosthetic options to the implant line. These abutments consist of two categories: (1) GPS straight abutments, and (2) Zirconia straight, angled, and modified Abutments.

GPS abutments are used in attachment-retained, tissue supported restorations where the patient is fully or partially edentulous in the arch to be restored. These abutments are sold non-sterile with an accompanying Instructions for Use that provides clinicians with pre-use sterilization instructions. These abutments are made from Titanium 6AL-4V ELI with the coronal region having a Titanium Nitride (TiN) coating The TiN coating process was validated through cytotoxict y testing in accordance with ISO 10993-5.

The Straight GPS abutments are a one-piece design secured to the implant having identical interface features as the previously cleared InterActive Ball Abutments (K130572) These abutments are available in 1,2,3,4, 5 and 6mm in height.

Zirconia abutments are intended for use in partially or fully edentulous mandible and maxillae in support of single or multiple unit cement retained restorations. The abutments consist of two pieces, the titanium base and the zirconia top. The Zirconia abutments have identical interface features as the previously cleared devices InterActive Cement Retained Abutments and Titanium Non-Engaging abutments (K130572). The abutments have a titanium base that has hex engaging and non-engaging implant/abutment interface having identical specifications as the previously cleared InterActive titanium abutments (K130572). The abutments have a coronal zirconia portion that is straight, angled, or it can be modified by the company to specific patient needs. The modifications to the top are restricted to minimal requirements: a maximum angle of 30° from the axis of the implant, a minimum wall thickness of 0.4mm, a minimum post height of 4mm, and a minimum cuff height from the interface of 0.7mm which are identical minimal requirements specified in the Instructions For Use for the previously cleared InterActive/SwishPlus2 abutments (K130572). These abutments are sold non-sterile with an accompanying Instructions for Use that provides clinicians with pre-use sterilization instructions.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the 2014 InterActive/SwishActive System.

Acceptance Criteria and Study for the 2014 InterActive/SwishActive System

This device, the 2014 InterActive/SwishActive System, is a line extension of previously cleared dental implants and abutments. The submission focuses on demonstrating substantial equivalence to existing predicate devices through non-clinical performance data, primarily mechanical fatigue testing and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Performance	Equivalent strength to predicate devices (InterActive Ball Abutments - K130572) according to ISO 14801.	GPS Straight Abutments with Implant Direct Implant: Proposed straight GPS abutments have an equivalent strength as the one-piece straight abutments (K130572).
	Equivalent or higher strength than predicate abutment (K130572) when assembled to NobelActive implants (K071370) according to ISO 14801.	GPS Straight Abutments with NobelActive Implant: Straight GPS abutments have an equivalent or higher strength as the predicate abutment (K130572). The straight GPS abutments have an equivalent strength when assembled to NobelActive implants (K071370).
	Equivalent strength to predicate abutment testing (K130572) for zirconia abutments according to ISO 14801.	Straight, Angled, and Modified Zirconia Abutments with InterActive Implant: The proposed zirconia abutment was tested, and the results show it to be equivalent to the predicate abutment testing (K130572).
Biocompatibility	Cytotoxicity testing in accordance with ISO 10993-5 and -12.	Cytotoxicity testing was conducted according to ISO 10993-5 and -12 to demonstrate biocompatibility of the proposed device. (Results: Pass)
Sterilization	Sterilization validation conducted to achieve a Sterility Assurance Level (SAL) of 10^-6, according to ANSI/AAMI ST79 and ISO 17665-1/-2.	Sterilization validation was conducted for the non-sterile components to ensure a SAL of 10^-6. Sterilization validation was conducted according to FDA consensus standards ANSI/AAMI ST79 and ISO 17665-1/-2. (Results: Pass)
Maximum Angulation (Zirconia)	Maximum of 30° angulation for Zirconia abutments when assembled to Implant Direct implants.	(Implied acceptance by non-clinical testing results confirming equivalence.)
	Maximum of 30° angulation for Zirconia abutments when assembled to NobelActive implants.	(Implied acceptance by non-clinical testing results confirming equivalence.)

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states "Non-Clinical Performance Data" and a later section states "[N/A] Clinical Performance Data". This indicates that the testing was performed on physical device samples, not on a human test set. Therefore, sample sizes for a clinical test set are not applicable here.

Sample Size for Test Set: Not applicable (non-clinical testing).
Data Provenance: Not applicable (non-clinical testing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. As the study is non-clinical, involving mechanical, biocompatibility, and sterilization testing, it would typically be conducted by engineers, technicians, and scientists specialized in these fields, following recognized international standards. "Ground truth" in this context refers to established material properties and performance benchmarks rather than expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the study is non-clinical. Adjudication methods are typically relevant for clinical studies where subjective assessments or conflicting interpretations of data by human readers or experts need to be resolved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable. The device under review is a dental implant system (implants and abutments), which are physical medical devices. There is no mention of AI integration or human-in-the-loop performance in the context of this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on established international standards and validated testing methodologies for mechanical performance (ISO 14801), biocompatibility (ISO 10993-5, -12), and sterilization (ANSI/AAMI ST79, ISO 17665-1/-2). The "ground truth" for equivalence is the performance of the legally marketed predicate devices, which have already demonstrated safety and effectiveness through their own compliance with these standards and clinical use.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical dental implant system, not a machine learning model that requires a training set. The "training" for such devices involves design, manufacturing, and process validation.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 16, 2015

Implant Direct Sybron Manufacturing LLC Ms. Ines Aravena Sr. Director, Product Development and Regulatory Affairs 3050 East Hillcrest Drive Thousand Oaks, California 91362

Re: K143011

Trade/Device Name: 2014 InterActive/SwishActive System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: June 18, 2015 Received: June 19, 2015

Dear Ms. Aravena,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image is a logo for Implant Direct, a Sybron Dental Specialties company. The logo is set against an orange background. The words "Implant Direct" are written in blue, with the tagline "simply smarter." written in a smaller, lighter font below. The words "Sybron Dental Specialties" are written in a smaller, lighter font below the tagline.

INDICATIONS FOR USE STATEMENT

K143011 510(k) Number (if known):

Device Name: 2014 InterActive/SwishActive System

Indications for Use:

Prescription Use __________ AND/OR (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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2014 InterActive/SwishActive SystemTraditional 510 (K) Submission

510(k) SUMMARY for 2014 InterActive/SwishActive System

1. Submitter Information:

Company:	Implant Direct Sybron Manufacturing LLC
Address:	3050 East Hillcrest Drive, Thousand Oaks,CA 91362 USA
Contact Person:	Debleena Sinha
Telephone Number:	818-444-3306
Fax Number:	818-444-3406
Date Prepared:	July 16, 2015
Device Name:
Proprietary Name:	2014 InterActive/SwishActive System
Classification Name:	Endosseous Dental Implant
CFR Number:	872.3640
Device Class:	II
Product Code:	DZE and NHA
Predicate Device:
Primary PredicateInterActive/SwishPlus2 Implant System (K130572)
Reference Predicate

NobelActive Internal Connection Implants (K071370) NobelActive Zirconia Abutment (K072129)

4. Description of Device:

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Image /page/4/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set against an orange background. The words "Implant Direct" are written in a dark blue font, with a blue arc above the words. Below the company name, the words "simply smarter" are written in a smaller, lighter font. The words "Sybron Dental Specialties" are written in a dark blue font at the bottom of the logo.

GPS Straight Abutments

Zirconia Straight, Angled, and Modified Abutments

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Image /page/5/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set on an orange background and features the company name in blue, with the words "simply smarter" in a smaller, lighter font underneath. A blue arc is above the company name. The text "Sybron Dental Specialties" is at the bottom of the logo.

2014 InterActive/SwishActive SystemTraditional 510 (K) Submission

devices InterActive Cement Retained Abutments and Titanium Non-Engaging abutments (K130572). The abutments have a titanium base that has hex engaging and non-engaging implant/abutment interface having identical specifications as the previously cleared InterActive titanium abutments (K130572). The abutments have a coronal zirconia portion that is straight, angled, or it can be modified by the company to specific patient needs. The modifications to the top are restricted to minimal requirements: a maximum angle of 30° from the axis of the implant, a minimum wall thickness of 0.4mm, a minimum post height of 4mm, and a minimum cuff height from the interface of 0.7mm which are identical minimal requirements specified in the Instructions For Use for the previously cleared InterActive/SwishPlus2 abutments (K130572). These abutments are sold non-sterile with an accompanying Instructions for Use that provides clinicians with pre-use sterilization instructions.

5. Indications for Use:

InterActive/SwishActive Implant System consists of two-piece implants for onestage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Narrow Diameter (3.2. 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

Description of Substantial Equivalence: 6.

Technological Characteristics

InterActive straight GPS abutments are one piece abutments with a apical threaded portion and coronal body that is compatible with InterActive and NobelActive implants. The coronal aspect of the InterActive abutments have similar external features as the NobelActive Locator abutments. Both abutments

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Image /page/6/Picture/0 description: The image is a logo for Implant Direct. The logo is set on an orange background. The words "Implant Direct" are in blue, with a blue arc above the words. Below the words "Implant Direct" is the phrase "simply smarter" in a smaller, lighter font. Below that is the phrase "Sybron Dental Specialties" in a similar font.

2014 InterActive/SwishActive SystemTraditional 510 (K) Submission

are made from titanium and both have a titanium nitride coating. The technological characteristics table (TABLE 1) is shown below comparing the predicates to the proposed straight GPS abutments.

TechnologicalCharacteristics	Primary PredicateDevice:	ReferencePredicate Device:	Proposed Device:
	InterActive BallAbutments(K130572)	NobelActive LocatorAbutments(K071370)	InterActiveGPS Straight Abutments
Regulation No.	21 CFR 872.3630	21 CFR 872.3630	21 CFR 872.3630
Regulation Class	II	II	II
Product Code	NHA	NHA	NHA
Intended Use	InterActive/SwishPlus2Implant System consists oftwo-piece implants for one-stage or two-stage surgicalprocedures. These implantsare intended for use inpartially and fullyedentulous upper and lowerjaws in support of single ormultiple-unit restorationsand terminal or intermediateabutment support for fixedbridgework. Implants can beindicated for immediateloading when good primarystability has been achievedand with appropriateocclusal loading.Narrow Diameter (3.2,3.3mm) Implants: Indicatedfor single-tooth replacementof mandibular central andlateral incisors andmaxillary lateral incisors.Also indicated for multipletooth replacements ordenture stabilization.Compatibility: InterActiveand SwishPlus2 implantsare prostheticallycompatible with InterActive3.0 and 3.4mm abutmentsand Nobel Biocare conicalconnection NobelActive™NP (Narrow Platform –3.0mm diameter) and	Nobel Biocare'sNobelActive implantsare endosseous implantintended to be surgicallyplaced in the bone of theupper or lower jawarches to provide supportfor prosthetic devices,such as an artificial tooth,in order to restore patientesthetics andchewing function. NobelBiocare's NobelActiveimplants are indicatedfor single or multipleunit restorations insplinted or non-splintedapplications. NobelBiocare's NobelActiveimplants may be placedimmediately and put intoimmediate functionprovided that initialstability requirementsdetailed in the manual aresatisfied.	InterActive/SwishActiveImplant System consists oftwo-piece implants for one-stage or two-stage surgicalprocedures. These implantsare intended for use inpartially and fullyedentulous upper and lowerjaws in support of single ormultiple-unit restorationsand terminal or intermediateabutment support for fixedbridgework. Implants can beindicated for immediateloading when good primarystability has been achievedand with appropriateocclusal loading.Narrow Diameter (3.2,3.3mm) Implants: Indicatedfor single-tooth replacementof mandibular central andlateral incisors andmaxillary lateral incisors.Also indicated for multipletooth replacements ordenture stabilization.Compatibility: InterActiveand SwishActive implantsare prostheticallycompatible with InterActive3.0 and 3.4mm abutmentsand Nobel Biocare conicalconnection NobelActive™NP (Narrow Platform –3.0mm diameter) and
TechnologicalCharacteristics	Predicate Device:InterActive BallAbutments(K130572)	Predicate Device:NobelActive LocatorAbutments(K071370)	Proposed Device:InterActiveGPS Straight Abutments
General Design	NobelActiveTM RP (RegularPlatform - 3.4mm diameter)abutments. InterActive 3.0and 3.4mm abutments areprosthetically compatiblewith Nobel Biocare conicalconnection NobelActiveTMNP (Narrow Platform-3.0mm diameter) andNobelActiveTM RP (RegularPlatform - 3.4mm diameter)(3.5-5.0mmD, 8.5-18mmLength) implants.Snap-on receiving capattachment systems withthread engaging feature	Snap-on receiving capattachment systems withthread engaging feature	NobelActiveTM RP (RegularPlatform - 3.4mm diameter)titanium abutments.Inter Active 3.0 and 3.4mmabutments are prostheticallycompatible with NobelBiocare conical connectionNobelActiveTM NP (NarrowPlatform- 3.0mm diameter)and NobelActiveTM RP(Regular Platform - 3.4mmdiameter) (3.5-5.0mmD,8.5-18mmLength) implants.Non-engaging straightabutments. Snap-onreceiving cap attachmentsystems with threadengaging feature
Material	Titanium alloy	Titanium alloy with TiNsurface	Titanium alloy with TiNsurface
AttachmentConnection	Ball Attachment	Locator TypeAttachment	GPS/Locator Attachment
Implant/abutInterface	3.0 and 3.4 mm diameterinterface	NP and RP interfaces	3.0 and 3.4 mm diameterinterface
Packaging	Non-sterile inside a vialsealed with a cap	Non-sterile inside a vialsealed with a cap	Non-sterile inside a vialsealed with a cap
TechnologicalCharacteristics	Primary PredicateDevices:InterActive Straight FullContour Abutments(K130572)	ReferencePredicate Devices:NobelActive Titanium,Zirconia Abutments(K071370), (K072129)	Proposed Device:InterActiveZirconia Angled,Straight, ModifiedAbutments
Regulation No.	21 CFR 872.3630	21 CFR 872.3630	21 CFR 872.3630
Regulation Class	II	II	II
Product Code	NHA	NHA	NHA
Intended Use	InterActive/SwishPlus2Implant System consists oftwo-piece implants for one-stage or two-stage surgicalprocedures. These implantsare intended for use inpartially and fullyedentulous upper and lowerjaws in support of single ormultiple-unit restorationsand terminal or intermediateabutment support for fixedbridgework. Implants can beindicated for immediateloading when good primarystability has been achievedand with appropriateocclusal loading.Narrow Diameter (3.2,3.3mm) Implants: Indicatedfor single-tooth replacementof mandibular central andlateral incisors andmaxillary lateral incisors.Also indicated for multipletooth replacements ordenture stabilization.Compatibility: InterActiveand SwishPlus2 implantsare prostheticallycompatible with InterActive3.0 and 3.4mm abutmentsand Nobel Biocare conicalconnection NobelActive™NP (Narrow Platform –3.0mm diameter) andNobelActive™ RP (RegularPlatform – 3.4mm diameter)abutments. InterActive 3.0and 3.4mm abutments areprosthetically compatiblewith Nobel Biocare conicalconnection NobelActive™NP (Narrow Platform–3.0mm diameter) and	Nobel Biocare'sNobelActive implantsare endosseous implantintended to be surgicallyplaced in the bone of theupper or lower jawarches to provide supportfor prosthetic devices,such as an artificial tooth,in order to restore patientesthetics andchewing function. NobelBiocare's NobelActiveimplants are indicatedfor single or multipleunit restorations insplinted or non-splintedapplications. NobelBiocare's NobelActiveimplants may be placedimmediately and put intoimmediate functionprovided that initialstability requirementsdetailed in the manual aresatisfied.The NobelActiveZirconia Abutment is apre-manufacturedprosthetic componentdirectly connected to theendosseous dentalimplant and is intendedfor use as an aid inprosthetic rehabilitationin the anterior region.	InterActive/SwishActiveImplant System consists oftwo-piece implants for one-stage or two-stagesurgical procedures. Theseimplants are intended foruse in partially and fullyedentulous upper andlower jaws in support ofsingle or multiple-unitrestorations and terminal orintermediate abutmentsupport for fixedbridgework. Implants canbe indicated for immediateloading when goodprimary stability has beenachieved and withappropriate occlusalloading.Narrow Diameter (3.2,3.3mm) Implants:Indicated for single-toothreplacement of mandibularcentral and lateral incisorsand maxillary lateralincisors. Also indicated formultiple toothreplacements or denturestabilization.Compatibility: InterActiveand SwishActive implantsare prostheticallycompatible withInterActive 3.0 and 3.4mmabutments and NobelBiocare conical connectionNobelActive™ NP(Narrow Platform – 3.0mmdiameter) andNobelActive™ RP(Regular Platform – 3.4mmdiameter) titaniumabutments. InterActive 3.0and 3.4mm abutments are
TechnologicalCharacteristics	Predicate Devices:InterActive Straight FullContour Abutments(K130572)	Predicate Devices:NobelActive Titanium,Zirconia Abutments(K071370), ( K072129)	Proposed Device:InterActiveZirconia Angled,Straight, ModifiedAbutments
	NobelActiveTM RP (RegularPlatform – 3.4mm diameter)(3.5-5.0mmD, 8.5-18mmLength) implants.		prosthetically compatiblewith Nobel Biocare conicalconnection NobelActiveTMNP (Narrow Platform—3.0mm diameter) andNobelActiveTM RP (RegularPlatform – 3.4mm diameter)(3.5-5.0mmD,8.5-18mmLength)implants.
General Design	One-piece abutmentconsisting of a engagingbase, a straight body, andsupplied with a fixationscrew. The abutment bodyis straight and is contouredto match the gingivalmargin for cement retainedprosthetics	One-piece abutmentconsisting of a titaniumor Zirconia abutmentthat are pre-manufactured straight,angled or custommodified, and suppliedwith a fixation screw.	Two-piece abutmentconsisting of a titaniumbase, Zirconia abutmenttop that is straight, angledor modified up to 30degrees, and supplied witha fixation screw.
Material	Titanium Alloy Base &Titanium Fixation Screw	Titanium Alloy orZirconia body &Titanium Fixation Screw	Titanium Alloy Base,Zirconia Crown, &Titanium Fixation Screw
Implant/abutInterface	3.0 and 3.4 mm diameterinterface	NP and RP interfaces	3.0 and 3.4 mm diameterinterface
Packaging	Non-sterile inside a vialsealed with a cap	Non-sterile inside a vialsealed with a cap	Non-sterile inside a vialsealed with a cap

TABLE 1: Comparison between Predicate Devices and Proposed Devices - GPS Straight Abutments

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Implant Direct
simply smarter.
Sybron Dental Specialties

2014 InterActive/SwishActive SystemTraditional 510 (K)

Submission

InterActive Zirconia abutments are two piece devices which have a titanium base with a anodized coating and coronal zirconia top which is provided as straight, angled, or modifiable according to patient needs. The apical portion of the InterActive abutments are compatible with NobelActive abutments. The coronal ziconia top is assembled to the titanium base and is made from a similar material as the NobelActive zirconia abutments. The NobelActive zirconia abutments are one piece abutments where the abutment body is made entirely from zirconia. The InterActive zirconia abutments differ from the NobelActive abutments by having a metalic titanium alloy base with a zirconia coronal top. The technological characteristics table (TABLE 2) is shown below comparing the predicates to the proposed zirconia abutments.

However, the differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate.

TABLE 2: Comparison between Predicate Devices and Proposed Devices - Zirconia Angled, Straight, Modified Abutments

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Image /page/8/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set on an orange background and features the company name in a bold, blue font. Below the company name is the tagline "simply smarter." and "Sybron Dental Specialties" in a smaller font.

2014 InterActive/SwishActive

SystemTraditional 510 (K)

Submission

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Image /page/9/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set against an orange background. The words "Implant Direct" are in a bold, blue font, with a blue arc above the words. Below the company name, the words "simply smarter" are in a smaller, lighter font. Below that, the words "Sybron Dental Specialties" are in a similar font.

2014 InterActive/SwishActive

SystemTraditional 510 (K) Submission

Non-Clinical Performance Data

Non-clinical testing was performed on InterActive implants and components. The testing is applicable for both proposed GPS and zirconia InterActive abutment types. Mechanical testing was performed according to ISO 14801 and was found to be equivalent to predicate device testing results. The following table (TABLE 3) gives a summary of the applicable testing.

TABLE 3: Summary of Fatigue performance data.

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Image /page/10/Picture/0 description: The image is a logo for Implant Direct, a Sybron Dental Specialties company. The logo features the words "Implant Direct" in a bold, blue font, with the tagline "simply smarter." in a smaller, lighter font. The words are set against an orange background. A blue arch is above the words "Implant Direct".

2014 InterActive/SwishActive

SystemTraditional 510 (K) Submission

ProposedDevices	Applicable Testing	Testing	Summary	Result
GPS StraightAbutments	InterActive StraightTitanium Abutmentwith Implant DirectImplant	Fatigue Testingaccording toISO 14801	Proposed straightGPS abutments havean equivalentstrength as the onepiece straightabutments(K130572). Thestraight GPSabutments have anequivalent strengthwhen assembled toImplant Directimplants(K130572).	Pass
GPS StraightAbutments	InterActive StraightTitanium Abutmentwith NobelActiveImplant	Fatigue Testingaccording toISO 14801	Straight GPSabutments have anequivalent or higherstrength as thepredicate abutment(K130572). Thestraight GPSabutments have anequivalent strengthwhen assembled toNobelActiveimplants(K071370).	Pass
Straight, Angled,and ModifiedZirconiaAbutments	InterActiveModified Zirconiaabutment withInterActive Implant	Fatigue Testingaccording toISO 14801	The proposedzirconia abutmentwas tested and theresults show it to beequivalent to thepredicate abutmenttesting (K130572).	Pass

Sterilization validation was conducted for the non-sterile components to ensure a SAL of 10-● 6. Sterilization validation was conducted according to FDA consensus standards ANSI/AAMI ST79 and ISO 17665-1/-2.
Cytotoxicity testing was conducted according to ISO 10993-5 and -12 to demonstrate ● biocompatibility of the proposed device

Clinical Performance Data [N/A]

Conclusion as to Substantial Equivalence

The differences between the proposed devices and the predicate devices were reviewed to evaluate the substantial equivalency. The following features are modifications to the cleared InterActive predicate abutment designs.

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· GPS coronal top added to one-piece design.
· Zirconia top added to straight, angled abutments.
Maximum of 30° angulation for Zirconia abutments when assembled to Implant Direct implants.
Maximum of 30° angulation for Zirconia abutments when assembled to NobelActive implants.

The non-clinical testing results show the proposed abutments meet the device requirements and are equivalent to the predicate devices. The subject devices and the predicate device have the same intended use and have the same technological characteristics.

Regulation Number and Section

§ 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.