(85 days)
No
The summary describes a dental implant system and its components, including digital workflow integration (scanners, CAD/CAM). While it mentions software for design, there is no indication of AI or ML being used for analysis, decision-making, or learning from data within the device or its associated software. The software validation focuses on design limitations and specifications, not AI/ML performance.
Yes
The device is an implant system, components of which are surgically placed in the jaw to support dental prosthetics, which directly treat edentulism (tooth loss).
No
The device is an implant system (implants, abutments, and associated components) used for dental restorations, rather than for diagnosing a condition or disease.
No
The device is a system of physical implants and abutments, with software being a component of the workflow for designing one part of the abutment. The core device is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for supporting dental restorations in the upper and lower jaws. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The description focuses on the physical components of the implant system and abutments, and the workflow for fabricating the abutments. This aligns with a medical device used for treatment.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Input Imaging Modality: While it uses input from Intra-Oral Scanners, this is for creating a model for the restoration, not for diagnostic analysis of the images themselves.
- Performance Studies: The performance studies focus on mechanical strength, biocompatibility, sterilization, and software validation – all relevant to the safety and efficacy of a therapeutic implant system, not a diagnostic device.
In summary, the InterActive/SwishActive Implant System and its SMARTBase abutments are designed to replace missing teeth and support dental restorations, which falls under the category of a medical device for therapeutic use, 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 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 internediate SMARTBase support for fixed bridgework. The system integrates of the digital dentistry workflow scan files from Intra-Oral Scanners, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two-piece abutment.
lmplants can be indicated for immediate loading when stability has been achieved and with appropriate occlusal loading.
- Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.
Compatibility:
InterActive SMARTBase abutments are compatible at the implant level with InterActive (3.0mm and 3.4mm Platform) and SwishActive (3.0mm and 3.4mm Platform) system implants.
Product codes
NHA, PNP
Device Description
The InterActive SMARTBase abutments system is a line extension of the previously cleared Implant Direct device, 2014 InterActive/SwishActive Implant System. The InterActive SMARTBase abutments are comprised of engaging abutments, non-engaging abutments, modified zirconia engaging abutments, modified zirconia non-engaging multiunit bridges, and fixation screws that are intended to function as an extension of the implant. The proposed SMARTBase Abutment is a two-piece abutment consisting of titanium base and zirconia top components. To fabricate the zirconia top component that fits the titanium base, there are three workflow options: (1) using a press-ceramic material that is formed by conventional wax-up technique by the end user, (2) the zirconia top component is designed and milled by Implant Direct in stock sizes and provided to the end user to be placed on the titanium base for forming two-piece abutment, and (3) digital workflow using 3Shape where CAD design and milling of the zirconia top component is done at the end user's dental laboratory/office to be placed on the titanium base. The CAD design requires loading of Implant Direct abutment design library to the 3Shape Software to design the zirconia top component within the established design limitations and specifications. The digital workflow includes the use of the following products (note that these are not subject devices to this submission):
- . Ceramic material: Zenostar MT
- Cement: EMBRACE Wetbond Resin Cement .
- Intra oral scanners: 3M Tru-Definition, ITero Scanner
- Abutment design software: 3Shape Abutment Designer™ Software (K151455) ●
- Milling machine: Wieland-Zenotec Select & Zenotec CAM .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially and fully edentulous upper and lower jaws
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental practitioner or dental laboratory staff
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
- Mechanical testing:
- Fatigue testing was performed on worst-case configuration of proposed devices per ISO 14801. Results indicated that the proposed SMARTBase abutments successfully completed endurance testing and was equivalent to the predicate devices.
- Screw Torque testing was performed on worst case drivers. Results indicated the drivers met the specified torque as the predicate device.
- Biocompatibility testing:
- Biological evaluation was conducted according to ISO 10993-1. Cytotoxicity testing per ISO 10993-5 was conducted on the finished devices. Results indicate that the devices met biocompatibility requirements for its intended use.
- Software Verification & Validation:
- Software verification and validation testing was provided for the subject abutment design library to demonstrate use with 3Shape Abutment Designer™ Software (K151455). Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the zirconia top component outside of design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library.
- Steam Sterilization Validation:
- The proposed devices are provided non-sterile and intended to be steam sterilized by the end user. Steam sterilization validation was performed on the primary predicate device per ISO 17665-1 and ISO 17665-2. The proposed devices have the same materials, same manufacturing processes, and same sterilization parameters as the predicate devices. The proposed devices are expected to meet the same sterilization requirements and thus no additional testing is needed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
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August 15, 2018
Implant Direct Sybron Manufacturing LLC Reina Choi Senior Regulatory Affairs Specialist 3050 East Hillcrest Drive Thousand Oaks, California 91362
Re: K181359
Trade/Device Name: InterActive SMARTBase Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: May 18, 2018 Received: May 22, 2018
Dear Reina Choi:
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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Food and Drug Administration
Indications for Use
Expiration Date: 06/30/2020
See PRA Statement below.
510(k) Number (if known)
K181359
Device Name
InterActive SMARTBase Abutments
Indications for Use (Describe)
InterActive/SwishActive Implant System consists of two-piece implants for one-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 internediate SMARTBase support for fixed bridgework. The system integrates of the digital dentistry workflow scan files from Intra-Oral Scanners, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two-piece abutment.
lmplants can be indicated for immediate loading when stability has been achieved and with appropriate occlusal loading.
- Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.
Compatibility:
InterActive SMARTBase abutments are compatible at the implant level with InterActive (3.0mm and 3.4mm Platform) and SwishActive (3.0mm and 3.4mm Platform) system implants.
| Manufacturer | Implant Line | Body Diameter | Implant Platform |
|---|---|---|---|
| Implant Direct | InterActive | 3.2mm, 3.7mm, 4.3mm, 5.0mm | 3.0mm, 3.4mm |
| Implant Direct | SwishActive | 3.3mm, 4.1mm, 4.8mm | 3.0mm, 3.4mm |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for Implant Direct. The logo consists of an orange and gray graphic on the left, followed by the text "IMPLANT DIRECT" in gray. The "TM" symbol is located to the right of the word "DIRECT".
3050 E. Hillcrest Drive
Thousand Oaks, CA 91362 USA
510(k) SUMMARY
1. SUBMITTER
Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362
Date Prepared: August 3, 2018
Contact Person: Reina Choi Senior Regulatory Affairs Specialist 818-444-3306 reina.choi@implantdirect.com
2. DEVICE NAME
| Proprietary Name: | InterActive SMARTBase Abutments |
|---|---|
| Classification Name: | Endosseous Dental Implant Abutment |
| (21 CFR 872.3630) | |
| Primary Product Code: | NHA |
| Secondary Product Code: | PNP |
3. PREDICATE DEVICE(S)
- InterActive/SwishActive Implant System (K143011) Primary Predicate ●
- . InterActive/SwishPlus2 Implant System (K130572) - Reference Device
- Sirona Dental CAD/CAM System (K111421) Reference Device .
- 3Shape Abutment Designer™ Software (K151455) Reference Device .
4. DEVICE DESCRIPTION
4
The InterActive SMARTBase abutments system is a line extension of the previously cleared Implant Direct device, 2014 InterActive/SwishActive Implant System. The InterActive SMARTBase abutments are comprised of engaging abutments, non-engaging abutments, modified zirconia engaging abutments, modified zirconia non-engaging multiunit bridges, and fixation screws that are intended to function as an extension of the implant. The proposed SMARTBase Abutment is a two-piece abutment consisting of titanium base and zirconia top components. To fabricate the zirconia top component that fits the titanium base, there are three workflow options: (1) using a press-ceramic material that is formed by conventional wax-up technique by the end user, (2) the zirconia top component is designed and milled by Implant Direct in stock sizes and provided to the end user to be placed on the titanium base for forming two-piece abutment, and (3) digital workflow using 3Shape where CAD design and milling of the zirconia top component is done at the end user's dental laboratory/office to be placed on the titanium base. The CAD design requires loading of Implant Direct abutment design library to the 3Shape Software to design the zirconia top component within the established design limitations and specifications. The digital workflow includes the use of the following products (note that these are not subject devices to this submission):
- . Ceramic material: Zenostar MT
- Cement: EMBRACE Wetbond Resin Cement .
- Intra oral scanners: 3M Tru-Definition, ITero Scanner
- Abutment design software: 3Shape Abutment Designer™ Software (K151455) ●
- Milling machine: Wieland-Zenotec Select & Zenotec CAM .
| Type | Material | Implant Platform/
Connection Hex | Abutment Diameter/
Cuff Heights | Post
Heights | Angulation |
|-------------------------------------------------------------------------|--------------------------------|-------------------------------------|------------------------------------|-----------------|-------------|
| Engaging
Abutments | Titanium
Alloy/
Zirconia | 3.0mmD/2.2mm
3.4mmD/2.6mm | 4.9mm Minimum/
1mm & 2mm | 4mm
Minimum | 0° to 30° |
| Non-engaging
Abutments | Titanium
Alloy/
Zirconia | 3.0mmD
3.4mmD | 5.7mm Minimum/
1mm & 2mm | 4mm
Minimum | 0° to 30° |
| Standard
Straight and
Angled
Zirconia
engaging
Abutments | Titanium
Alloy/
Zirconia | 3.0mmD/2.2mm
3.4mmD/2.6mm | 4.9 mm Minimum/
1mm & 2mm | 4mm
Minimum | 0°, 8°, 15° |
| Modified
Zirconia
engaging | Titanium
Alloy/
Zirconia | 3.0mmD/2.2mm
3.4mmD/2.6mm | 4.9mm Minimum/
1mm & 2mm | 4mm
Minimum | 0° to 30° |
TABLE 1. Product Specifications
5
| Abutments | |||||
|---|---|---|---|---|---|
| Modified | |||||
| zirconia non- | |||||
| engaging | |||||
| multi-unit | |||||
| bridges | Titanium | ||||
| Alloy/ | |||||
| Zirconia | 3.0mmD | ||||
| 3.4mmD | 5.7mm Minimum/ | ||||
| 1mm & 2mm | N/A | 0 to 30° | |||
| Fixation | |||||
| Screws | Titanium | ||||
| Alloy | 3.0mmD | ||||
| 3.4mmD | N/A | N/A | N/A |
TABLE 2. Compatible Implants with Proposed InterActive SMARTBase Abutments
| Implant Brand
| (Manufacturer) | 510(k) # | Model |
|---|---|---|
| Implant Direct Sybron | ||
| Manufacturing, LLC | K143011 | |
| K130572 | InterActive Implant System and | |
| SwishActive Implant System (Conical | ||
| connection) |
5. 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 SMARTBase support for fixed bridgework. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two-piece abutment.
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 SMARTBase abutments are compatible at the implant level with InterActive (3.0mm and 3.4mm Platform) and SwishActive (3.0mm and 3.4mm Platform) system implants.
| Manufacturer | Implant Line | Body Diameter | Implant Platform |
|---|---|---|---|
| -------------- | -------------- | --------------- | ------------------ |
6
| Implant Direct | InterActive | 3.2mm, 3.7mm, 4.3mm, 5.0mm | 3.0mm, 3.4mm |
|---|---|---|---|
| Implant Direct | SwishActive | 3.3mm, 4.1mm, 4.8mm | 3.0mm, 3.4mm |
7
| Technological
Characteristics | Proposed Device:
InterActive
SMARTBase Abutments
(K181359) | Primary Predicate:
InterActive Engaging
Abutments(K143011) | Reference Device:
InterActive Non-Engaging
Abutments (K130572) | Reference Device: Sirona
Dental CAD/CAM-System
(K111421) | Reference Device:
3Shape Abutment
Designer™ Software
(K151455) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Implant Direct Sybron
Manufacturing, LLC | Implant Direct Sybron
Manufacturing, LLC | Implant Direct Sybron
Manufacturing, LLC | Dentsply - Sirona | 3Shape |
| 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 SMARTBase
abutment support for fixed
bridgework. The system
integrates multiple components
of the digital dentistry workflow:
scan files from Intra-Oral
Scanners, CAD software, CAM
software, ceramic material,
milling machine and associated
tooling and accessories. The
SMARTBase Abutments consist
of two major parts. Specifically,
the titanium base and zirconia
top components make up a two-
piece abutment.
Implants can be indicated for
immediate loading when good
primary stability has been | 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. | 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. | The Sirona Dental CAD/CAM
System is intended for use in
partially or fully edentulous
mandibles and maxillae in
support of single or multiple-
unit cement retained
restorations. The system
consists of three major parts:
TiBase, InCoris mesostructure,
and CAD/CAM software.
Specifically, the InCoris
mesostructure and TiBase
components make up a two-
piece abutment which is used
in conjunction with
endosseous dental implants to
restore the function and
aesthetics in the oral cavity.
The InCoris mesostructure
may also be used in
conjunction with the Camlog
Titanium base CAD/CAM
(types K2244.xxxx)
(K083496) in the Camlog
Implant System. The
CAD/CAM software is
intended to design and
fabricate the InCoris
mesostructure. | The 3Shape Abutment
Designer Software is
intended as an aid to the
restoration of chewing
function in partially or
fully edentulous
mandibles and maxillae.
The 3Shape Abutment
Designer Software is
intended for use by a
dental practitioner or
dental laboratory staff for
designing the patient
specific component of a
two-piece, one-piece or
hybrid dental implant
abutment. The single or
multi-unit abutment
design is intended to be
used by the manufacturer
of an endosseous dental
implant abutment to
create the final device. |
| Technological
Characteristics | Proposed Device:
InterActive
SMARTBase Abutments
(K181359) | Primary Predicate:
InterActive Engaging
Abutments(K143011) | Reference Device:
InterActive Non-Engaging
Abutments (K130572) | Reference Device: Sirona
Dental CAD/CAM-System
(K111421) | Reference Device:
3Shape Abutment
Designer™ Software
(K151455) |
| | 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 SMARTBase
abutments are compatible at the
implant level with InterActive
(3.0mm and 3.4mm Platform)
and SwishActive (3.0mm and
3.4mm Platform) system
implants. | 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)
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. | 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 NobelActive™
RP (Regular Platform -
3.4mm diameter) (3.5-
5.0mmD, 8.5-18mmLength)
implants. | The InCoris mesostructure and
TiBase two-piece abutment is
compatible with the following
implant systems: Nobel
Biocare Replace (K020646),
Nobel Biocare Branemark
(K022562), Friadent Xive
(K013867), Biomet 3i
Osseotite (K980549), Astra
Tech Osseospeed (K091239),
Zimmer Tapered Screw-Vent
(K061410), Straumann
Synocta (K061176),
Straumann Bone Level
(K053088), Biomet 3i Certain
(K014235), Nobel Biocare
Active (K071370). | N/A |
| Technological
Characteristics | Proposed Device:
InterActive
SMARTBase Abutments
(K181359) | Primary Predicate:
InterActive Engaging
Abutments(K143011) | Reference Device:
InterActive Non-Engaging
Abutments (K130572) | Reference Device: Sirona
Dental CAD/CAM-System
(K111421) | Reference Device:
3Shape Abutment
Designer™ Software
(K151455) |
| General
Design | Abutment body consisting of a
titanium base and supplied with
a fixation screw. The bases are
provided with straight, angled,
and modified zirconia tops for
patient specific devices. The
devices are also provided
without a zirconia top and a
superstructure or hybrid crown
or bridge can be milled to fit the
bases intended to be
manufactured at Implant Direct
Manufacturing facility. | Abutment body consisting of a
titanium base and supplied with
a fixation screw. The bases are
provided with straight, angled,
or a modified top intended to be
manufactured at Implant Direct
Manufacturing facility. | Abutment body consisting of a
titanium base and supplied
with a fixation screw. The
bases are provided without a
restoration. | The TiBase is a
premanufactured prosthetic
component directly connected
to endosseous dental implants
with a screw and is intended
for use as an aid in prosthetic
rehabilitation. | N/A |
| Abutment
Angle | 0° to 30° | 0° to 30° | 0° to 30° | 0° to 20° | N/A |
| Restoration | Single Unit, Multi-Unit | Single Unit, Multi-Unit | Multi-Unit | Single Unit, Multi-Unit | N/A |
| Post Height | Single Unit - Minimum 4 mm
Multi-Unit - Minimum 4 mm | Single Unit - Minimum 4 mm
Multi-Unit - Minimum 4 mm | Minimum of 4mm height
required | Minimum 4mm | N/A |
| Anti-Rotation
Feature | Single Unit - One Flat
Multi-Unit - One Flat | Single Unit - Three Vertical
Grooves at 120°
Multi-Unit - One Anti-Rotation
Key | Multi-Unit - One Flat | Single anti-rotation feature | N/A |
| Prosthesis
Attachment | Screw Retained | Screw or Cement Retained | Acrylic | Screw or Cement
Retained | N/A |
| Screw Thread | M1.6, M2 | M1.6, M2 | M1.6, M2 | M1.6, M2
(NobelActive) | N/A |
| Technological
Characteristics | Proposed Device:
InterActive
SMARTBase Abutments
(K181359) | Primary Predicate:
InterActive Engaging
Abutments(K143011) | Reference Device:
InterActive Non-Engaging
Abutments (K130572) | Reference Device: Sirona
Dental CAD/CAM-System
(K111421) | Reference Device:
3Shape Abutment
Designer™ Software
(K151455) |
| Interface
Platform | 3.0mm and 3.4mm Platform | 3.0mm and 3.4mm Platform | 3.0mm and 3.4mm Platform | NobelActive, NP and RP | N/A |
| Interface
Connection | Engaging and Non-Engaging
Internal Hex Conical connection | Engaging and Non-Engaging
Internal Hex Conical
connection | Non-Engaging | Engaging and Non-Engaging
Internal Hex Conical
connection | N/A |
| Implant
Compatibility | InterActive 3.0mm and 3.4mm | InterActive 3.0mm and 3.4mm
and NobelActive NP and RP | InterActive 3.0mm and 3.4mm
and NobelActive NP and RP | NobelActive NP and RP | N/A |
| Abutment
Material | Titanium & Zirconia | Titanium & Zirconia | Titanium | Tibase - Titanium 6AL4V,
Cercon HT | N/A |
| Abutment
Surface
Treatment | Abutments are titanium anodized
gold and pink (grooves are
machined for cement adhesion). | Abutments are anodized gold
(grooves are machined for
cement adhesion). | None. (grooves are machined
for acrylic adhesion) | Cemented surfaces are blasted
with aluminum oxide. | N/A |
| Cement
(Adhesive) | EMBRACE | EMBRACE | Acrylic | Panavia F2.0 | N/A |
| Screw
Material | Titanium | Titanium | Titanium | Titanium | N/A |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | N/A |
| Sterilization
Method | Steam Sterilization | Steam Sterilization | Steam Sterilization | Steam Sterilization | N/A |
| Use | Single-Use | Single-Use | Single-Use | Single-Use | N/A |
| Technological
Characteristics | Proposed Device:
InterActive
SMARTBase Abutments
(K181359) | Primary Predicate:
InterActive Engaging
Abutments(K143011) | Reference Device:
InterActive Non-Engaging
Abutments (K130572) | Reference Device: Sirona
Dental CAD/CAM-System
(K111421) | Reference Device:
3Shape Abutment
Designer™ Software
(K151455) |
| Packaging | Inside a vial sealed with a cap | Inside a vial sealed with a cap | Inside a vial sealed with a cap | Unknown | N/A |
6. TECHNOLOGICAL CHARACTERISTICS COMPARISON
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The proposed device has the same intended use and similar technological characteristics to that of the predicate device and reference devices. The proposed SMARTBase devices are different from the primary predicate devices, K143011, by 1) having a different titanium anodize color, 2) having a different anti-rotation feature for the zirconia top, 3) using a digital workflow, and 4) having a minimum zirconia wall thickness that is 0.2mm larger. The proposed devices are different from the reference devices (K130572 and K111421) by 1) having a titanium anodize color, 2) having a different anti-rotation feature for the zirconia top, and 3) having a different cement.
The anodize process used for the proposed SMARTBase is the same as the primary predicate devices (K143011). The reference devices (K130572) are not processed through a titanium anodize procedure. The proposed titanium anodizing colors only changes the oxide layer thickness. The thickness of the oxide layer determines the color of the device. The anti-rotation feature is used to orient the zirconia top to the correct position. The antirotation feature in the SMARTBase is a flat rather than three vertical grooves as in the primary predicate device. The reference device (K130572) has the same type of antirotation feature as the proposed device. The reference device (K111421) has a machined titanium key that fits into an internal keyway in the zirconia to prevent rotation. The proposed device uses different cement for attachment from those used in the references devices. The proposed device uses 3Shape Abutment Designer Software, while the reference device (K111421) uses Sirona Dental CAD/CAM Software. Both software (3Shape and Sirona Dental CAD/CAM Software) provide a digital design output file that is used for fabricating the finished device. The proposed devices include the two-piece abutments as a physical output as well as a validated manufacture process. The reference device 3Shape Abutment Designer Software does not provide any physical parts that come into contact with patient and only provides the digital design as an accessory to the physical dental abutment system. The differences in the indications for use of the proposed device and the reference device (3Shape Abutment Designer Software) are related to a lack of a physical output from the reference device.
Overall, any noted differences have been evaluated and supported by non-clinical testing and therefore do not affect substantial equivalence.
7. NON-CLINICAL TESTING
Non-clinical testing was performed on the proposed device. Testing include mechanical strength, biocompatibility, cleaning and steam sterilization validation, and software verification & validation. Successful test results indicated that the subject device will perform as intended and support the substantial equivalence of the InterActive SMARTBase abutments.
- Mechanical testing
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- Fatigue testing was performed on worst-case configuration of proposed devices per o ISO 14801. Results indicated that the proposed SMARTBase abutments successfully completed endurance testing and was equivalent to the predicate devices.
- Screw Torque testing was performed on worst case drivers. Results indicated the o drivers met the specified torque as the predicate device.
- Biocompatibility testing
- o Biological evaluation was conducted according to ISO 10993-1. Cytotoxicity testing per ISO 10993-5 was conducted on the finished devices. Results indicate that the devices met biocompatibility requirements for its intended use.
- Software Verification & Validation
Software verification and validation testing was provided for the subject abutment design library to demonstrate use with 3Shape Abutment Designer™ Software (K151455). Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the zirconia top component outside of design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library.
- Steam Sterilization Validation
- The proposed devices are provided non-sterile and intended to be steam sterilized O by the end user. Steam sterilization validation was performed on the primary predicate device per ISO 17665-1 and ISO 17665-2. The proposed devices have the same materials, same manufacturing processes, and same sterilization parameters as the predicate devices. The proposed devices are expected to meet the same sterilization requirements and thus no additional testing is needed.
8. CLINICAL TESTING
Clinical performance testing has not been performed. Clinical testing is not needed to support substantial equivalence.
9. CONCLUSION
The intended use, the indications for use, and technological characteristics of the proposed devices are similar to those of the predicate devices. Any noted differences between the proposed and predicate devices do not affect the intended use and have been addressed by the performance data. Based on the intended use, technological characteristics, and
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applicable performance data included in this submission, the proposed devices have been shown to be substantially equivalent to the predicate devices.