2014 InterActive/SwishActive System

K143011 · Implant Direct Sybron Manufacturing, LLC · DZE · Jul 16, 2015 · Dental

Device Facts

• Record ID: K143011
• Device Name: 2014 InterActive/SwishActive System
• Applicant: Implant Direct Sybron Manufacturing, LLC
• Product Code: DZE · Dental
• Decision Date: Jul 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

System comprises two-piece endosseous dental implants and various abutments (GPS straight, Zirconia straight/angled/modified). Implants surgically placed in jaw bone by clinicians; provide support for prosthetic restorations. GPS abutments feature titanium alloy with TiN coating; Zirconia abutments feature titanium base with zirconia coronal top. Components connect to implants via conical interface; compatible with NobelActive implants/abutments. Used in dental clinics for edentulous patients. Output is stable prosthetic foundation; enables restoration of chewing function and esthetics. Benefits include expanded prosthetic options and compatibility with existing NobelActive systems.

Clinical Evidence

No clinical data. Bench testing only. Fatigue testing performed per ISO 14801; results confirm equivalent strength to predicate devices. Biocompatibility testing conducted per ISO 10993-5 and -12.

Technological Characteristics

Endosseous dental implants and abutments. Materials: Titanium 6AL-4V ELI, Titanium Nitride (TiN) coating, Zirconia. Design: Two-piece implants, GPS straight abutments, Zirconia straight/angled/modified abutments. Interface: Conical connection (3.0mm/3.4mm). Standards: ISO 14801 (fatigue), ISO 10993-5/-12 (biocompatibility), ANSI/AAMI ST79/ISO 17665-1/-2 (sterilization). Non-sterile, requires pre-use sterilization.

Indications for Use

Indicated for partially and fully edentulous upper and lower jaws requiring single or multiple-unit restorations or fixed bridgework support. Narrow diameter implants indicated for single-tooth replacement of mandibular central/lateral incisors and maxillary lateral incisors, or multiple tooth replacements/denture stabilization. Suitable for immediate loading if primary stability and occlusal loading conditions are met.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• InterActive/SwishPlus2 Implant System (K130572)

Reference Devices

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

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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:

2.

3.

| Company: | Implant Direct Sybron Manufacturing LLC |
|----------------------------------------------------------------------|-----------------------------------------------------------|
| Address: | 3050 East Hillcrest Drive, Thousand Oaks,<br>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 Predicate<br>InterActive/SwishPlus2 Implant System (K130572) | |
| Reference Predicate | |

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

#### 4. Description of Device:

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.

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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.

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 Straight 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 Straight, Angled, and Modified Abutments

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

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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.

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.

- 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.

| Technological<br>Characteristics | Primary Predicate<br>Device: | Reference<br>Predicate Device: | Proposed Device: |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | InterActive Ball<br>Abutments<br>(K130572) | NobelActive Locator<br>Abutments<br>(K071370) | InterActive<br>GPS 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/SwishPlus2<br>Implant System consists of<br>two-piece implants for one-<br>stage or two-stage surgical<br>procedures. These implants<br>are intended for use in<br>partially and fully<br>edentulous upper and lower<br>jaws in support of single or<br>multiple-unit restorations<br>and terminal or intermediate<br>abutment support for fixed<br>bridgework. Implants can be<br>indicated for immediate<br>loading when good primary<br>stability has been achieved<br>and with appropriate<br>occlusal loading.<br><br>Narrow Diameter (3.2,<br>3.3mm) Implants: Indicated<br>for single-tooth replacement<br>of mandibular central and<br>lateral incisors and<br>maxillary lateral incisors.<br>Also indicated for multiple<br>tooth replacements or<br>denture stabilization.<br><br>Compatibility: InterActive<br>and SwishPlus2 implants<br>are prosthetically<br>compatible with InterActive<br>3.0 and 3.4mm abutments<br>and Nobel Biocare conical<br>connection NobelActive™<br>NP (Narrow Platform –<br>3.0mm diameter) and | Nobel Biocare's<br>NobelActive implants<br>are endosseous implant<br>intended to be surgically<br>placed in the bone of the<br>upper or lower jaw<br>arches to provide support<br>for prosthetic devices,<br>such as an artificial tooth,<br>in order to restore patient<br>esthetics and<br>chewing function. Nobel<br>Biocare's NobelActive<br>implants are indicated<br>for single or multiple<br>unit restorations in<br>splinted or non-splinted<br>applications. Nobel<br>Biocare's NobelActive<br>implants may be placed<br>immediately and put into<br>immediate function<br>provided that initial<br>stability requirements<br>detailed in the manual are<br>satisfied. | InterActive/SwishActive<br>Implant System consists of<br>two-piece implants for one-<br>stage or two-stage surgical<br>procedures. These implants<br>are intended for use in<br>partially and fully<br>edentulous upper and lower<br>jaws in support of single or<br>multiple-unit restorations<br>and terminal or intermediate<br>abutment support for fixed<br>bridgework. Implants can be<br>indicated for immediate<br>loading when good primary<br>stability has been achieved<br>and with appropriate<br>occlusal loading.<br><br>Narrow Diameter (3.2,<br>3.3mm) Implants: Indicated<br>for single-tooth replacement<br>of mandibular central and<br>lateral incisors and<br>maxillary lateral incisors.<br>Also indicated for multiple<br>tooth replacements or<br>denture stabilization.<br><br>Compatibility: InterActive<br>and SwishActive implants<br>are prosthetically<br>compatible with InterActive<br>3.0 and 3.4mm abutments<br>and Nobel Biocare conical<br>connection NobelActive™<br>NP (Narrow Platform –<br>3.0mm diameter) and |
| Technological<br>Characteristics | Predicate Device:<br>InterActive Ball<br>Abutments<br>(K130572) | Predicate Device:<br>NobelActive Locator<br>Abutments<br>(K071370) | Proposed Device:<br>InterActive<br>GPS Straight Abutments |
| General Design | NobelActiveTM RP (Regular<br>Platform - 3.4mm diameter)<br>abutments. InterActive 3.0<br>and 3.4mm abutments are<br>prosthetically compatible<br>with Nobel Biocare conical<br>connection NobelActiveTM<br>NP (Narrow Platform-<br>3.0mm diameter) and<br>NobelActiveTM RP (Regular<br>Platform - 3.4mm diameter)<br>(3.5-5.0mmD, 8.5-<br>18mmLength) implants.<br>Snap-on receiving cap<br>attachment systems with<br>thread engaging feature | Snap-on receiving cap<br>attachment systems with<br>thread engaging feature | NobelActiveTM RP (Regular<br>Platform - 3.4mm diameter)<br>titanium abutments.<br>Inter Active 3.0 and 3.4mm<br>abutments are prosthetically<br>compatible with Nobel<br>Biocare conical connection<br>NobelActiveTM NP (Narrow<br>Platform- 3.0mm diameter)<br>and NobelActiveTM RP<br>(Regular Platform - 3.4mm<br>diameter) (3.5-5.0mmD,<br>8.5-18mmLength) implants.<br>Non-engaging straight<br>abutments. Snap-on<br>receiving cap attachment<br>systems with thread<br>engaging feature |
| Material | Titanium alloy | Titanium alloy with TiN<br>surface | Titanium alloy with TiN<br>surface |
| Attachment<br>Connection | Ball Attachment | Locator Type<br>Attachment | GPS/Locator Attachment |
| Implant/abut<br>Interface | 3.0 and 3.4 mm diameter<br>interface | NP and RP interfaces | 3.0 and 3.4 mm diameter<br>interface |
| Packaging | Non-sterile inside a vial<br>sealed with a cap | Non-sterile inside a vial<br>sealed with a cap | Non-sterile inside a vial<br>sealed with a cap |
| Technological<br>Characteristics | Primary Predicate<br>Devices:<br>InterActive Straight Full<br>Contour Abutments<br>(K130572) | Reference<br>Predicate Devices:<br>NobelActive Titanium,<br>Zirconia Abutments<br>(K071370), (K072129) | Proposed Device:<br>InterActive<br>Zirconia Angled,<br>Straight, Modified<br>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/SwishPlus2<br>Implant System consists of<br>two-piece implants for one-<br>stage or two-stage surgical<br>procedures. These implants<br>are intended for use in<br>partially and fully<br>edentulous upper and lower<br>jaws in support of single or<br>multiple-unit restorations<br>and terminal or intermediate<br>abutment support for fixed<br>bridgework. Implants can be<br>indicated for immediate<br>loading when good primary<br>stability has been achieved<br>and with appropriate<br>occlusal loading.<br>Narrow Diameter (3.2,<br>3.3mm) Implants: Indicated<br>for single-tooth replacement<br>of mandibular central and<br>lateral incisors and<br>maxillary lateral incisors.<br>Also indicated for multiple<br>tooth replacements or<br>denture stabilization.<br>Compatibility: InterActive<br>and SwishPlus2 implants<br>are prosthetically<br>compatible with InterActive<br>3.0 and 3.4mm abutments<br>and Nobel Biocare conical<br>connection NobelActive™<br>NP (Narrow Platform –<br>3.0mm diameter) and<br>NobelActive™ RP (Regular<br>Platform – 3.4mm diameter)<br>abutments. InterActive 3.0<br>and 3.4mm abutments are<br>prosthetically compatible<br>with Nobel Biocare conical<br>connection NobelActive™<br>NP (Narrow Platform–<br>3.0mm diameter) and | Nobel Biocare's<br>NobelActive implants<br>are endosseous implant<br>intended to be surgically<br>placed in the bone of the<br>upper or lower jaw<br>arches to provide support<br>for prosthetic devices,<br>such as an artificial tooth,<br>in order to restore patient<br>esthetics and<br>chewing function. Nobel<br>Biocare's NobelActive<br>implants are indicated<br>for single or multiple<br>unit restorations in<br>splinted or non-splinted<br>applications. Nobel<br>Biocare's NobelActive<br>implants may be placed<br>immediately and put into<br>immediate function<br>provided that initial<br>stability requirements<br>detailed in the manual are<br>satisfied.<br>The NobelActive<br>Zirconia Abutment is a<br>pre-manufactured<br>prosthetic component<br>directly connected to the<br>endosseous dental<br>implant and is intended<br>for use as an aid in<br>prosthetic rehabilitation<br>in the anterior region. | InterActive/SwishActive<br>Implant System consists of<br>two-piece implants for one-<br>stage or two-stage<br>surgical procedures. These<br>implants are intended for<br>use in partially and fully<br>edentulous upper and<br>lower jaws in support of<br>single or multiple-unit<br>restorations and terminal or<br>intermediate abutment<br>support for fixed<br>bridgework. Implants can<br>be indicated for immediate<br>loading when good<br>primary stability has been<br>achieved and with<br>appropriate occlusal<br>loading.<br>Narrow Diameter (3.2,<br>3.3mm) Implants:<br>Indicated for single-tooth<br>replacement of mandibular<br>central and lateral incisors<br>and maxillary lateral<br>incisors. Also indicated for<br>multiple tooth<br>replacements or denture<br>stabilization.<br>Compatibility: InterActive<br>and SwishActive implants<br>are prosthetically<br>compatible with<br>InterActive 3.0 and 3.4mm<br>abutments and Nobel<br>Biocare conical connection<br>NobelActive™ NP<br>(Narrow Platform – 3.0mm<br>diameter) and<br>NobelActive™ RP<br>(Regular Platform – 3.4mm<br>diameter) titanium<br>abutments. InterActive 3.0<br>and 3.4mm abutments are |
| Technological<br>Characteristics | Predicate Devices:<br>InterActive Straight Full<br>Contour Abutments<br>(K130572) | Predicate Devices:<br>NobelActive Titanium,<br>Zirconia Abutments<br>(K071370), ( K072129) | Proposed Device:<br>InterActive<br>Zirconia Angled,<br>Straight, Modified<br>Abutments |
| | NobelActiveTM RP (Regular<br>Platform – 3.4mm diameter)<br>(3.5-5.0mmD, 8.5-<br>18mmLength) implants.…