(269 days)
No
The document describes a dental implant system and its components, focusing on materials, dimensions, compatibility, and mechanical testing. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The InterActive/SwishActive Implant System is used for the replacement of missing teeth, which restores function and improves the patient's quality of life. This constitutes a therapeutic effect.
No
Explanation: This device is an implant system used for surgical procedures to support dental restorations. It is designed for treatment rather than for diagnosis.
No
The device description clearly details physical components such as implants and abutments made of materials like titanium and zirconia, and discusses mechanical testing and sterilization validation, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this system consists of implants and abutments intended for surgical implantation into the jawbone to support dental restorations. This is a surgical device used in vivo (within the body), not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic testing, or providing information about a patient's health based on laboratory results.
Therefore, the InterActive/SwishActive Implant System is a dental implant system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaws, mandibular central and lateral incisors, maxillary lateral incisors, mandible and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Summary of Fatigue performance data:
- GPS Straight Abutments with Implant Direct Implant: Fatigue Testing according to ISO 14801. Proposed straight GPS abutments have an equivalent strength as the one piece straight abutments (K130572). The straight GPS abutments have an equivalent strength when assembled to Implant Direct implants(K130572). Result: Pass
- GPS Straight Abutments with NobelActive Implant: Fatigue Testing according to ISO 14801. 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). Result: Pass
- Straight, Angled, and Modified Zirconia Abutments with InterActive Implant: Fatigue Testing according to ISO 14801. The proposed zirconia abutment was tested and the results show it to be equivalent to the predicate abutment testing (K130572). Result: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a way that they appear interconnected. The profiles are black against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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
2
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)
3
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 Predicate | |
| 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.
4
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
5
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
6
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
Characteristics | Primary Predicate
Device: | Reference
Predicate Device: | Proposed Device: |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | InterActive Ball
Abutments
(K130572) | NobelActive Locator
Abutments
(K071370) | InterActive
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
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.
Also indicated for multiple
tooth replacements or
denture stabilization.
Compatibility: InterActive
and SwishPlus2 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 | Nobel Biocare's
NobelActive implants
are endosseous implant
intended to be surgically
placed in the bone of the
upper or lower jaw
arches to provide support
for prosthetic devices,
such as an artificial tooth,
in order to restore patient
esthetics and
chewing function. Nobel
Biocare's NobelActive
implants are indicated
for single or multiple
unit restorations in
splinted or non-splinted
applications. Nobel
Biocare's NobelActive
implants may be placed
immediately and put into
immediate function
provided that initial
stability requirements
detailed in the manual are
satisfied. | 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.
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 |
| Technological
Characteristics | Predicate Device:
InterActive Ball
Abutments
(K130572) | Predicate Device:
NobelActive Locator
Abutments
(K071370) | Proposed Device:
InterActive
GPS Straight Abutments |
| General Design | NobelActiveTM RP (Regular
Platform - 3.4mm diameter)
abutments. InterActive 3.0
and 3.4mm abutments are
prosthetically compatible
with Nobel Biocare conical
connection NobelActiveTM
NP (Narrow Platform-
3.0mm diameter) and
NobelActiveTM RP (Regular
Platform - 3.4mm diameter)
(3.5-5.0mmD, 8.5-
18mmLength) implants.
Snap-on receiving cap
attachment systems with
thread engaging feature | Snap-on receiving cap
attachment systems with
thread engaging feature | NobelActiveTM RP (Regular
Platform - 3.4mm diameter)
titanium abutments.
Inter Active 3.0 and 3.4mm
abutments are prosthetically
compatible with Nobel
Biocare conical connection
NobelActiveTM NP (Narrow
Platform- 3.0mm diameter)
and NobelActiveTM RP
(Regular Platform - 3.4mm
diameter) (3.5-5.0mmD,
8.5-18mmLength) implants.
Non-engaging straight
abutments. Snap-on
receiving cap attachment
systems with thread
engaging feature |
| Material | Titanium alloy | Titanium alloy with TiN
surface | Titanium alloy with TiN
surface |
| Attachment
Connection | Ball Attachment | Locator Type
Attachment | GPS/Locator Attachment |
| Implant/abut
Interface | 3.0 and 3.4 mm diameter
interface | NP and RP interfaces | 3.0 and 3.4 mm diameter
interface |
| Packaging | Non-sterile inside a vial
sealed with a cap | Non-sterile inside a vial
sealed with a cap | Non-sterile inside a vial
sealed with a cap |
| Technological
Characteristics | Primary Predicate
Devices:
InterActive Straight Full
Contour Abutments
(K130572) | Reference
Predicate Devices:
NobelActive Titanium,
Zirconia Abutments
(K071370), (K072129) | Proposed Device:
InterActive
Zirconia Angled,
Straight, Modified
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
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.
Also indicated for multiple
tooth replacements or
denture stabilization.
Compatibility: InterActive
and SwishPlus2 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)
abutments. InterActive 3.0
and 3.4mm abutments are
prosthetically compatible
with Nobel Biocare conical
connection NobelActive™
NP (Narrow Platform–
3.0mm diameter) and | Nobel Biocare's
NobelActive implants
are endosseous implant
intended to be surgically
placed in the bone of the
upper or lower jaw
arches to provide support
for prosthetic devices,
such as an artificial tooth,
in order to restore patient
esthetics and
chewing function. Nobel
Biocare's NobelActive
implants are indicated
for single or multiple
unit restorations in
splinted or non-splinted
applications. Nobel
Biocare's NobelActive
implants may be placed
immediately and put into
immediate function
provided that initial
stability requirements
detailed in the manual are
satisfied.
The NobelActive
Zirconia Abutment is a
pre-manufactured
prosthetic component
directly connected to the
endosseous dental
implant and is intended
for use as an aid in
prosthetic rehabilitation
in the anterior region. | 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. 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 |
| Technological
Characteristics | Predicate Devices:
InterActive Straight Full
Contour Abutments
(K130572) | Predicate Devices:
NobelActive Titanium,
Zirconia Abutments
(K071370), ( K072129) | Proposed Device:
InterActive
Zirconia Angled,
Straight, Modified
Abutments |
| | NobelActiveTM RP (Regular
Platform – 3.4mm diameter)
(3.5-5.0mmD, 8.5-
18mmLength) implants. | | prosthetically compatible
with Nobel Biocare conical
connection NobelActiveTM
NP (Narrow Platform—
3.0mm diameter) and
NobelActiveTM RP (Regular
Platform – 3.4mm diameter)
(3.5-5.0mmD,
8.5-18mmLength)
implants. |
| General Design | One-piece abutment
consisting of a engaging
base, a straight body, and
supplied with a fixation
screw. The abutment body
is straight and is contoured
to match the gingival
margin for cement retained
prosthetics | One-piece abutment
consisting of a titanium
or Zirconia abutment
that are pre-
manufactured straight,
angled or custom
modified, and supplied
with a fixation screw. | Two-piece abutment
consisting of a titanium
base, Zirconia abutment
top that is straight, angled
or modified up to 30
degrees, and supplied with
a fixation screw. |
| Material | Titanium Alloy Base &
Titanium Fixation Screw | Titanium Alloy or
Zirconia body &
Titanium Fixation Screw | Titanium Alloy Base,
Zirconia Crown, &
Titanium Fixation Screw |
| Implant/abut
Interface | 3.0 and 3.4 mm diameter
interface | NP and RP interfaces | 3.0 and 3.4 mm diameter
interface |
| Packaging | Non-sterile inside a vial
sealed with a cap | Non-sterile inside a vial
sealed with a cap | Non-sterile inside a vial
sealed with a cap |
TABLE 1: Comparison between Predicate Devices and Proposed Devices - GPS Straight Abutments
7
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
8
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
9
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.
10
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
| Proposed
| Devices | Applicable Testing | Testing | Summary | Result |
|---|---|---|---|---|
| GPS Straight | ||||
| Abutments | InterActive Straight | |||
| Titanium Abutment | ||||
| with Implant Direct | ||||
| Implant | Fatigue Testing | |||
| according to | ||||
| ISO 14801 | Proposed straight | |||
| GPS abutments have | ||||
| an equivalent | ||||
| strength as the one | ||||
| piece straight | ||||
| abutments | ||||
| (K130572). The | ||||
| straight GPS | ||||
| abutments have an | ||||
| equivalent strength | ||||
| when assembled to | ||||
| Implant Direct | ||||
| implants(K130572). | Pass | |||
| GPS Straight | ||||
| Abutments | InterActive Straight | |||
| Titanium Abutment | ||||
| with NobelActive | ||||
| Implant | Fatigue Testing | |||
| according to | ||||
| ISO 14801 | 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). | Pass | |||
| Straight, Angled, | ||||
| and Modified | ||||
| Zirconia | ||||
| Abutments | InterActive | |||
| Modified Zirconia | ||||
| abutment with | ||||
| InterActive Implant | Fatigue Testing | |||
| according to | ||||
| ISO 14801 | The proposed | |||
| zirconia abutment | ||||
| was tested and the | ||||
| results show it to be | ||||
| equivalent to the | ||||
| predicate abutment | ||||
| testing (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.
11
Image /page/11/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 a blue arc above the name. Below the company name is the tagline "simply smarter" in white, and below that is "Sybron Dental Specialties" in a smaller font.
- · 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.