(263 days)
No
The 510(k) summary describes a mechanical dental abutment and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an abutment for dental implants, providing support for prosthetic restorations. It does not actively treat or cure a disease but rather serves as a structural component for dental reconstruction.
No
Explanation: The device is described as a dental abutment designed to provide support for prosthetic restorations in patients with missing teeth. Its function is structural and restorative, not diagnostic.
No
The device description clearly states it is a two-piece physical abutment designed to be used with dental implants, and the performance studies involve mechanical testing and sterilization validation of physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations. This describes a device used in vivo (within the body) for structural support, not a device used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description further reinforces its use in conjunction with dental implants for prosthetic support, again indicating an in vivo application.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any of the typical characteristics of an IVD.
Therefore, the GPS® Angled Abutments are a medical device used for dental restoration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
GPS® Angled Abutments are designed to be used in conjunction with dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
The proposed GPS® Angled Abutments are intended to provide extra prosthetic options currently unavailable to the clinician. The proposed abutments are intended to complement the cleared systems listed in Table 2 below. The proposed abutments have the same compatible implant interface specific to each implant system and platform size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 the proposed GPS® Angled abutments.
Mechanical testing was performed on the proposed devices following FDA "Class II Special Control Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 in static compression and fatigue. The worst case abutment testing was performed on the proposed abutments with Implant Direct implants and with compatible third party implants. The implant/abutment device combinations were able to withstand an equivalent or higher load than the primary predicate device.
In addition, validations were conducted on non-sterile abutments for steam sterilization and biocompatibility testing.
A steam sterilization validation was conducted using the same sterilization parameters specified in the instructions for use which is used for the proposed devices. A sterilization validation was conducted on a non-sterile abutment conforming to AAMI/ANSI/ISO 17665-1 and ANSVAAMI ST79 to a sterility assurance level (SAL) of 10 -6. In addition, the compatible GPS comfort cap was validated to be steam sterilizable.
Biocompatibility testing was conducted on the devices made with the same material and processes as the GPS components. Testing was conducted on the proposed Angled GPS Abutments, primary predicate GoDirect implant and compatible comfort caps according to ISO 10993-5. The results did not show a toxic reaction from the proposed finished devices.
The non-clinical performance data demonstrates that the proposed GPS® Angled abutments are mechanically equivalent, can be steam sterilized, and are biocompatible for the intended use.
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
§ 872.3630 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.)
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2016
Implant Direct Sybron Manufacturing, LLC Ms. Renee Bennett Regulatory Affairs Specialist 3050 East Hillcrest Drive Thousand Oaks, California 91362
Re: K153509
Trade/Device Name: GPS® Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 27, 2016 Received: July 28, 2016
Dear Ms. Bennett:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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
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
Indications for Use
510(k) Number (if known) K153509
Device Name GPS® Angled Abutments
Indications for Use (Describe)
GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Compatibility:
· Legacy System: Prosthetically compatible with Zimmer Dental Tapered Screw-Vent system implants (3.7mmD, 4.1mmD, 8mm-16mm Length), 4.5mm platform implants(4.7mmD, 8mm-16mm Length), and 5.7mm platform implants (6.0mmD, 8mm-16mm Length).
•SwishTapered System: Prosthetically compatible with Straumann Standard Plus system RN platform implants (3.3mmD-4.8mmD, 6mm-16mm Length) and WN platform implants(4.8mmD, 6mm-12mm Length). •SwishPlus System: Prosthetically compatible with Straumann Standard Plus system RN platform implants (3.3mmD-4.8mmD, 6mm-16mm Length) and WN platform implants (4.8mmD, 6mm-12mm Length). •SwishActive Implants: 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 connection NobelActive™ NP (Narrow Platform-3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD. 8.5-18mmLength). • InterActive System: InterActive 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 Nobel Active™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY for GPS® Angled Abutments
1. Submitter Information:
| Company: | Implant Direct Sybron Manufacturing LLC |
|---|---|
| Address: | 3050 East Hillcrest Drive, Thousand Oaks |
| CA 91362 USA | |
| Contact Person: | |
| Telephone Number: | Renee Bennett |
| 818-444-3348 | |
| Date Prepared: | August 16, 2016 |
| Device Name: | |
| ● Proprietary Name: | GPS® Angled Abutments |
| ● Classification Name: | Endosseous Dental Implant Abutment |
| ● CFR Number: | 872.3630 |
| ● Device Class: | II |
| ● Product Code: | NHA |
| Predicate Device: | Primary: GoDirect implants cleared under |
| K090234 - Spectra System Dental Implants | |
| 2008 | |
| Reference: Straight GPS abutments cleared | |
| under K130572 - InterActive/SwishPlus2 | |
| Implant System | |
| Reference: Screw Receiving abutment with | |
| Ball top cleared under K143011- 2014 | |
| InterActive / SwishActive System |
4
Description of Device: 4.
GPS® Angled Abutments are designed to be used in conjunction with dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
The proposed GPS® Angled Abutments are intended to provide extra prosthetic options currently unavailable to the clinician. The proposed abutments are intended to complement the cleared systems listed in Table 2 below. The proposed abutments have the same compatible implant interface specific to each implant system and platform size.
| # | System Name | 510(k) | Proposed
Compatible GPS®
Abutments |
|---|------------------------------------------|---------|-----------------------------------------------------|
| 1 | InterActive SwishPlus2
Implant System | K130572 | InterActive®
SwishActive GPS
Angled Abutments |
| 2 | Legacy Abutment System | K060063 | Legacy GPS® Angled
Abutments |
| 3 | Spectra System
(RePlant) | K061319 | Replant GPS® Angled
Abutments |
| 4 | Swissplant Dental Implant
System | K081396 | Swish GPS® Angled
Abutments |
TABLE 1: List of cleared Implant Direct systems and the proposed compatible GPS® angled abutments
From Table 1, the worst case GPS® Angled abutment is the InterActive® /SwishActive GPS® Angled Abutment, 3.0 mm Platform. The 3.0 mm platform assembly represents the smallest size abutment from the InterActive system. Since the 3.4 mm implant and screw size is larger, the abutments are stronger than the 3.0 mm platform abutments. Hence, the 3.0 mm platform represents the worst case.
New fatigue testing has been completed on the worst case proposed GPS® Angled Abutment assembly..
The GPS® Angled abutments have the same coronal GPS Angled Top for all proposed GPS® Angled abutments. The GPS top has a superior outer radius at its coronal region that is identical to the primary predicate GoDirect implants (K090234 - Spectra System Dental Implants 2008). Since the proposed GPS® Angled abutments have the same coronal top design as the primary predicate GoDirect implants (K090234 - Spectra System Dental Implants 2008), the same compatibility will be achieved with the Zest
5
Locator® liner type attachments manufactured by Zest Anchor, Inc.
-
- Indications for Use:
GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
- Indications for Use:
Compatibility:
·Legacy System: Prosthetically compatible with Zimmer Dental Tapered Screw-Vent system 3.5mm platform implants (3.7mmD, 4.1mmD, 8mm-16mm Length), 4.5mm platform implants(4.7mmD, 8mm-16mm Length), and 5.7mm platform implants (6.0mmD, 8mm-16mm Length).
·SwishTapered System: Prosthetically compatible with Straumann Standard and Standard Plus system RN platform implants (3.3mmD-4.8mmD, 6mm-16mm Length) and WN platform implants(4.8mmD, 6mm-12mm Length).
·SwishPlus System: Prosthetically compatible with Straumann Standard and Standard Plus system RN platform implants (3.3mmD-4.8mmD, 6mm-16mm Length) and WN platform implants (4.8mmD, 6mm-12mm Length).
·SwishActive Implants: 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).
·InterActive System: InterActive 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 Safety and Substantial Equivalence:
Technological Characteristics
The proposed Implant Direct Sybron Manufacturing LLC GPS® Angled abutments have the same intended use and technological characteristics and hence are shown to be substantially equivalent to the primary predicate device GoDirect implants (cleared under K090234 - Spectra System Dental Implants 2008). The proposed GPS Angled abutments and primary predicate GoDirect implants
6
(K090234) system contains both implants and abutments, and the intended use reflects this. The difference in the indications for use of the proposed devices and the primary predicate was due to the GoDirect implant being cleared with other Implant Direct implants (K090234), as part of the Spectra-System Dental Implants 2008. Also, the primary predicate was originally cleared with implants that are intended for both single unit and multi-unit restorations, while the proposed devices are only indicated for multi-unit bridge or overdentures and not for single unit restorations. Thus, the proposed devices have more limited indications for use than the primary predicate that does not alter the intended use for demonstration of substantial equivalence.
In addition, the reference predicate GPS Straight Abutments (cleared under K143011- 2014 InterActive / SwishActive System) and the reference predicate InterActive® Screw Receiving Overdenture abutment with a ball top (cleared under K130572 - InterActive/SwishPlus2 Implant System) are also considered substantially equivalent. The worst case proposed angled GPS abutment uses the same compatible implant interfaces, have the same thread size, same materials, same coatings, and same manufacturing processes as reference predicate abutments (K143011 - 2014 InterActive / SwishActive System).
The proposed GPS Angled abutments have the same coronal top features as the primary predicate GoDirect Implant (K090234 - Spectra System Dental Implants 2008) and reference predicate GPS Straight Abutments (cleared under K143011 -2014 InterActive / SwishActive System). The proposed GPS® Angled abutments are a two-piece design having an identical lower piece with same interface features and angles as the reference predicate InterActive screw receiving angled abutments with a ball top (K130572 - InterActive/SwishPlus2 Implant System).
The proposed GPS® Angled Abutments differ from the primary predicate by having a two piece design with an angled body that utilizes a GPS top piece in order to have the same GPS compatibility with removable attachments.
These changes do not affect substantial equivalence of the proposed devices as demonstrated by internal performance and biocompatibility testing. GPS® Angled Abutment are substantially equivalent to the primary predicate GoDirect device cleared under (K090234 - Spectra System Dental Implants 2008) based on composition, performance and testing comparisons.
7
| Technological
Characteristics | Proposed
Device: GPS®
Angled
Abutment | Primary Predicate
Device:
GoDirect Implants
(K090234 – Spectra
System Dental
Implants 2008) | Reference Predicate
Device: Straight
GPS Abutment
(K143011 - 2014
InterActive/
SwishActive
System) | Reference
Predicate Device:
InterActive®
Swishplus2
Implant System
(Abutment with
Ball Top)
(K130572 -
InterActive/
SwishPlus2
Implant System) |
|----------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Implant Direct
LLC | Implant Direct LLC | Implant Direct LLC | Implant Direct LLC |
| Regulation No. | 21 CFR 872. 3630 | 21 CFR 872. 3640 | 21 CFR 872. 3640 | 21 CFR 872. 3640 |
| Regulation
Class | II | II | II | II |
| Product Code | NHA | DZE, NHA | DZE, NHA | DZE, NHA |
| Technological
Characteristics | Proposed
Device: GPS®
Angled
Abutment | Primary Predicate
Device:
GoDirect Implants
(K090234 - Spectra
System Dental
Implants 2008) | Reference Predicate
Device: Straight
GPS Abutment
(K143011 - 2014
InterActive/
SwishActive
System) | Reference
Predicate Device:
InterActive®
Swishplus2
Implant System
(Abutment with
Ball Top)
(K130572 –
InterActive/
SwishPlus2
Implant System) |
| Indications
for Use | GPS® Angled
Abutments are
designed to be
used in support
| Spectra-System
Dental implants 2008
are comprised of dental
implant fixtures and
prosthetic devices that
compose a two- piece
implant system. The
implants are intended
for the use in the
mandible and maxilla,
in support of single unit
or multiple unit cement
or screw receiving
restorations and for
retention and support
of
overdentures.
The implants are
intended for immediate
placement and function
for the support of
single tooth or
multiple-tooth
restorations,
recognizing bone
stability and
appropriate occlusal
load requirements. | 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. | 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 |
TABLE 2: Substantial Equivalence: Comparison of Proposed Device with Predicate on Technological Characteristics
8
9
| Compatibility: |
|---|
| •Legacy System: |
| Prosthetically |
| compatible with |
| Zimmer Dental |
| Tapered Screw-Vent |
| system 3.5mm |
| platform implants |
| (3.7mmD, 4.1mmD, |
| 8mm-16mm |
| Length), 4.5mm |
| platform |
| implants(4.7mmD, |
| 8mm-16mm |
| Length), and 5.7mm |
| platform implants |
| (6.0mmD, 8mm- |
| 16mm Length). |
| •SwishTapered |
| System: |
| Prosthetically |
| compatible with |
| Straumann Standard |
| and Standard Plus |
| system RN platform |
| implants (3.3mmD- |
| 4.8mmD, 6mm- |
| 16mm Length) and |
| WN platform |
| implants(4.8mmD, |
| 6mm-12mm |
| Length). |
| •SwishPlus System: |
| Prosthetically |
| compatible with |
| Straumann Standard |
| and Standard Plus |
| system RN platform |
| implants (3.3mmD- |
| 4.8mmD, 6mm- |
| 16mm Length) and |
| WN platform |
| implants (4.8mmD, |
| 6mm-12mm |
| Length). |
10
| Technological
Characteristics | Proposed
Device: GPS®
Angled
Abutment | Primary Predicate
Device:
GoDirect Implants
(K090234 – Spectra
System Dental
Implants 2008) | Reference Predicate
Device: Straight
GPS Abutment
(K143011 – 2014
InterActive/
SwishActive
System) | Reference
Predicate Device:
InterActive®
Swishplus2
Implant System
(Abutment with
Ball Top)
(K130572 –
InterActive/
SwishPlus2
Implant System) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SwishActive Implants:
SwishActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActiveTM NP (Narrow Platform – 3.0mm diameter) and NobelActiveTM RP (Regular Platform – 3.4mm diameter) titanium 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). | | | |
11
| InterActive System:
InterActive
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. | ||
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -- | -- |
12
| | General
Design | 2-piece abutment
with a GPS top for
compatibility with a
snap-on cap
attachment system
and a implant
engaging feature
with 15 degree and
30 degree angled
base. | GPS top integrated into
coronal end of implant
utilizing snap-on cap
attachment systems. | 1-piece abutment with
a GPS top for
compatibility with
snap-on cap
attachment system
and with a threaded
outer body to attach to
implant. | 2-piece abutment with
a ball top for
compatibility with a
snap-on cap
attachment system
and a implant
engaging feature with
15 degree and 30
degree angled base. |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| a) | Fixation
screw
Design | Same | N/A | Different | Same |
| | b) Lower
piece
design | Same | N/A | Different | Same |
| c) | Coronal
top design
(Outer
Features) | Same | Same | Same | Different |
| Technological
Characteristics | Proposed
Device: GPS®
Angled
Abutment | Primary Predicate
Device:
GoDirect Implants
(K090234 - Spectra
System Dental
Implants 2008) | Reference Predicate
Device: Straight
GPS Abutment
(K143011 - 2014
InterActive/
SwishActive
System) | Reference
Predicate Device:
InterActive®
Swishplus2
Implant System
(Abutment with
Ball Top)
(K130572 -
InterActive/
SwishPlus2
Implant System) | |
| d) Coronal
top design
(Internal
Features) | Same | Same | Different | Different | |
| e) Abutment
Angle | 15° and 30° | 0° | 0° | 15° and 30° | |
| f) Abutment /
Implant
Interface
Type | Engaging | N/A | Non-engaging | Engaging | |
| g) Attachment
-Abutment
Interface
Platform | 3.9mm | 3.9mm | 3.9mm | 2.54mm | |
| Material | Titanium alloy
base with TiN
coating | Titanium alloy base
with TiN coronal
surface | Titanium alloy
base with TiN
coating | Titanium alloy
base | |
| Sterilization: | Provided non-
sterile with
validated steam
sterilization
instructions for
use. Product
label indicates
sterility
according to ISO
standard. | Provided sterile. No
sterilization
instructions needed for
sterile product.
Sterilization process is
validated. Product label
indicates sterility
according to ISO
standard. | Provided non-
sterile with
validated steam
sterilization
instructions for use.
Product label
indicates sterility
according to ISO
standard. | Provided non-
sterile with
validated steam
sterilization
instructions for use.
Product label
indicates sterility
according to ISO
standard. | |
| Packaging | Mounted to inner
vial, inside an
outer vial and
sealed with a cap | Mounted to inner vial,
inside an outer vial and
sealed with a cap | Mounted to inner
vial, inside an outer
vial and sealed
with a cap | Mounted to inner
vial, inside an outer
vial and sealed
with a cap | |
13
14
Non-Clinical Performance Data
Non-clinical testing was performed on the proposed GPS® Angled abutments.
Mechanical testing was performed on the proposed devices following FDA "Class II Special Control Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 in static compression and fatigue. The worst case abutment testing was performed on the proposed abutments with Implant Direct implants and with compatible third party implants. The implant/abutment device combinations were able to withstand an equivalent or higher load than the primary predicate device.
In addition, validations were conducted on non-sterile abutments for steam sterilization and biocompatibility testing.
A steam sterilization validation was conducted using the same sterilization parameters specified in the instructions for use which is used for the proposed devices. A sterilization validation was conducted on a non-sterile abutment conforming to AAMI/ANSI/ISO 17665-1 and ANSVAAMI ST79 to a sterility assurance level (SAL) of 10 -6. In addition, the compatible GPS comfort cap was validated to be steam sterilizable.
Biocompatibility testing was conducted on the devices made with the same material and processes as the GPS components. Testing was conducted on the proposed Angled GPS Abutments, primary predicate GoDirect implant and compatible comfort caps according to ISO 10993-5. The results did not show a toxic reaction from the proposed finished devices.
The non-clinical performance data demonstrates that the proposed GPS® Angled abutments are mechanically equivalent, can be steam sterilized, and are biocompatible for the intended use.
Clinical Performance Data [N/A]
Clinical data is not needed to adequately characterize substantial equivalence.
Conclusion as to Substantial Equivalence
The differences between the proposed devices and the predicate device were reviewed to evaluate the substantial equivalency. The following features are modifications to the primary predicate device.
- · The proposed Angled GPS abutments are a multiple piece design using an angled abutment, fixation screw, and a GPS top to make the complete assembly. In comparison, the primary predicate GoDirect implant (K090234 - Spectra System Dental Implants 2008) is a solid
15
device where the coronal end of the implant is machined with GPS features. The coronal end of the GoDirect implant has the same features (including coating) as the GPS top (P/N: 1000-90S).
- The proposed Angled GPS abutments are manufactured at angles of 15° and 30°. The primary predicate device GPS top is straight and aligned with the implant axis.
The technical characteristics and non - c l i n i c a 1 performance data demonstrate that the proposed GPS® Angled Abutments are substantially equivalent to the primary predicate device (GoDirect implant cleared under K090234 - Spectra System Dental Implants 2008).