(357 days)
No
The summary describes a dental abutment system and its associated digital workflow components (scanners, CAD/CAM software, milling machines, materials). While it mentions design software and digital scanning, there is no indication or mention of AI or ML being used in the design process, analysis, or any other part of the device's function or workflow. The design is described as custom using standard CAD software with limitations, not through AI/ML algorithms.
No.
The document describes the device as a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation to restore chewing function, consistent with a restorative device rather than a therapeutic one.
No
Explanation: The device is a dental abutment system used for prosthetic rehabilitation to restore chewing function. It supports dental restorations on endosseous implants. Its purpose is structural and restorative, not diagnostic.
No
The device description clearly states the device includes physical components: a titanium base and a zirconia mesostructure restoration. While it utilizes software in its workflow, the device itself is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "prosthetic rehabilitation" and "restoring chewing function." This describes a device used directly on a patient to replace missing teeth and restore function, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical component (titanium base and zirconia mesostructure) that is implanted and used to support a dental restoration. It describes a mechanical function, not a diagnostic one.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls used in laboratory testing
The device is clearly a dental prosthetic component used in a restorative procedure.
N/A
Intended Use / Indications for Use
The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAM software, ceramic material, milling machine and associated tooling and accessories.
Product codes
NHA, PNP
Device Description
This submission includes two major components which make up the TIB Abutment Base and the mesostructure restoration.
The TIB Abutment base is a standard premanufactured titanium alloy abutment for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.
The mesostructured restoration is a CAD/CAM designed prosthesis milled out of zirconia, which is designed to fit the abutment base in order to restore chewing for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case by case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.
The TIB Abutments are compatible with the Southern Implants' Deep Conical, External Hex, Provata and Tri-Nex implants and screws. The TIB abutment bases are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by gold anodizing. The anodization process is the same as used for previously cleared anodized titanium alloy devices in K163634. The Mesostructure restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K 130991.
The digital workflow includes the following products (not subject devices to this submission):
- Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991)
- Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
- Desktop scanner: 3Shape E3 Desktop Scanner is 510(k) exempt under regulation . 872.3661)
- Abutment design software: 3Shape Abutment Designer Software (K151455)
- Milling machine: Roland DWX51D Milling Machine
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scan files from desktop scanners
Anatomical Site
Endosseous dental implants
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental laboratory (for fabrication), prosthetic rehabilitation (aid)
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 data submitted, referenced, or relied upon to demonstrate substantial equivalence include: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments; Biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1. "Biological evaluation of medical devices - Partl: Evaluation and testing within a risk management process" and ISO 10993-5 "Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity": validated sterilization instructions per ISO 17665-2; software validation testing per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices; scanning and milling validation; and static and dynamic compression-bending to ISO 14801. No clinical data was included in this submission.
Key results:
- The difference in scanner was shown to not affect substantial equivalence by way of software validation, scanning and milling validation, and static and dynamic compression-bending according to ISO 14801.
- Biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1. "Biological evaluation of medical devices – Partly Evaluation and testing within a risk management process", and validated sterilization instructions per the FDA Guidance Document for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling.
- The screw threads differing with the addition of intermediary screw threads does not impact demonstrating substantial equivalence, and this was shown with static and dynamic compression-bending according to ISO 14801.
- The manufacturing workflow differing with CAM software and milling unit brands does not impact demonstrating substantial equivalence, and this was shown by of software validation, scanning and milling validation, and dynamic compression-bending according to ISO 14801.
- Mechanical ISO 14801 Fatigue Testing of all four implant platforms proves substantial equivalence of the compatible implant platforms.
- Biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1, "Biological evaluation of medical devices – Part1: Evaluation and testing within a risk management process" was performed for biocompatibility of materials.
- The inclusion of the 3Shape software (K151455) was validated with performance testing per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K180899, Universal Base Abutment, Nobel Biocare
Reference Device(s)
K181359, K111421, K163634, K130991, K130436, K151455
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.)
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2020
Southern Implants (Pty) Ltd Lauranda Breytenbach Head of Regulatory Affairs and Quality 1 Albert Road Irene, Gauteng 0062 REPUBLIC OF SOUTH AFRICA
Re: K193084
Trade/Device Name: TIB Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: October 19, 2020 Received: October 20, 2020
Dear Lauranda Breytenbach:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193084
Device Name TIB Abutment System
Indications for Use (Describe)
The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAM software, ceramic material, milling machine and associated tooling and accessories.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
K193084
TIB Abutment System
Southern Implants (Pty) Ltd
October 27, 2020
ADMINISTRATIVE INFORMATION
Manufacturer Name
Official Contact
Southern Implants (Pty) Ltd 1 Albert Road Irene, Gauteng, 0062 South Africa +27 12 667 1046 Telephone Fax +27 12 667 1029
Lauranda G. Breytenbach Head of Regulatory Affairs and Quality Email: lauranda.b(@southernimplants.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary name Common name
Classification name Classification regulation Product Code
Classification Panel Reviewing Branch
TIB Abutment System Dental Abutment
Endosseous Dental Implant Abutment 21 CFR 872.3630, Class II NHA, PNP
Dental Products Panel Dental Devices Branch
PREDICATE DEVICE INFORMATION
The primary predicate device is K180899 The reference predicate devices are K181359, K111421, K163634, K130991, K130436 and K151455
4
INDICATIONS FOR USE STATEMENT
The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
SUBJECT DEVICE DESCRIPTION
This submission includes two major components which make up the TIB Abutment Base and the mesostructure restoration.
The TIB Abutment base is a standard premanufactured titanium alloy abutment for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.
The mesostructured restoration is a CAD/CAM designed prosthesis milled out of zirconia, which is designed to fit the abutment base in order to restore chewing for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case by case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.
The TIB Abutments are compatible with the Southern Implants' Deep Conical, External Hex, Provata and Tri-Nex implants and screws. The TIB abutment bases are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by gold anodizing. The anodization process is the same as used for previously cleared anodized titanium alloy devices in K163634. The Mesostructure restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K 130991.
The digital workflow includes the following products (not subject devices to this submission):
- Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991) ●
- Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) ●
- Desktop scanner: 3Shape E3 Desktop Scanner is 510(k) exempt under regulation . 872.3661)
- . Abutment design software: 3Shape Abutment Designer Software (K151455)
- Milling machine: Roland DWX51D Milling Machine ●
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments; Biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1. "Biological evaluation of medical devices - Partl: Evaluation and testing within a risk management process" and ISO 10993-5 "Biological Evaluation of Medical Devices – Part 5: Tests for In
5
Vitro Cytotoxicity": validated sterilization instructions per ISO 17665-2; software validation testing per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices; scanning and milling validation; and static and dynamic compression-bending to ISO 14801. No clinical data was included in this submission.
EQUIVALENCE TO MARKETED DEVICE
Southern Implants (Pty) Ltd submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
K180899, Universal Base Abutment, Nobel Biocare K111421, Sirona Dental CAD/CAM System, Dentsply Sirona K181359, InterActive SMARTBase Abutments, Implant Direct K163634, External Hex Implants, Southern Implants K130991, Zirconia restorative material, SageMaxx NexxZr K130436, Multilink Hybrid Abutment Cement, Ivoclar Vivadent K151455, 3Shape Abutment Designer Software, 3Shape A/S
The primary predicate is K180899.
The reference predicate devices are K181359, K111421, K163634, K130991, K130436 and K151455.
A comparison of the technological characteristics of the subject device and the predicate devices is provided in the following table.
| Subject Abutment | Primary Predicate | Reference Predicates | ||||
|---|---|---|---|---|---|---|
| Characteristics | Southern | |||||
| Implants | ||||||
| TIB | ||||||
| Abutment | Universal Base | |||||
| Abutment | ||||||
| (K180899) | InterActive | |||||
| SMARTBase | ||||||
| Abutments (K181359) | Sirona | |||||
| CAD/CAM | ||||||
| (K111421) | Dental | |||||
| System | Southern | |||||
| Implants | ||||||
| External | ||||||
| (K163634) | ||||||
| Abutment Design | 2 Piece - | |||||
| Premanufactured | ||||||
| titanium abutment, | ||||||
| mounted onto the | ||||||
| implant and fixed | ||||||
| with a screw. | ||||||
| SageMaxx Zirconia | ||||||
| (K130991) | ||||||
| hybrid/crown | ||||||
| restoration milled | ||||||
| and bonded to the | ||||||
| titanium abutment. | 2 Piece - Enamic | |||||
| (K153645) bonded to | ||||||
| Universal Base | ||||||
| Abutment mounted | ||||||
| onto the implant and | ||||||
| fixed with a screw | 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's | 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. | Sterile: Cover Screw, | |||||
| Healing Caps, | ||||||
| Abutments, | ||||||
| Titanium Abutments, | ||||||
| Anatomic | ||||||
| Abutments, Cosmetic | ||||||
| Abutments, | ||||||
| Compact Abutments |
Non-sterile:
Abutments,
Chrome Abutments,
Passive Abutments |
| Maximum
Abutment
Angulation | 20° | 20° | 30° | 20° | - | - |
| Restoration
Material | Zirconia - Sage
Maxx NexxZr
(K130991) | Enamic (K153645) | Zenostar MT | Cercon HT | - | |
| Post Height | Minimum 4.5mm | Minimum 5.2mm | Single Unit - Minimum 4 mm
Multi-Unit -
Minimum 4 mm | Minimum 4mm | - | |
| | Subject Abutment | Primary Predicate | Reference Predicates | | | |
| Characteristics | Southern
Implants
TIB
Abutment | Universal
Base
Abutment
(K180899) | Inter Active
SMARTBase
Abutments (K181359) | Sirona
Dental
CAD/CAM
System
(K111421) | Southern
Implants
External
Hex
(K163634) | |
| Screw Thread | 1-72 unf-2b, M1.6,
M1.8 and M2 | Not available | M1.6, M2 | M1.6,
M2
(NobelActive) | M2 | |
| Compatible
Implant Platforms | Southern Implants:
External
Hex
Implants
Provata Implants
Deep Conical
Implants
Tri-Nex Implants | Nobel Biocare
External Hex
Narrow Platform
(NP)
Regular Platform
(RP)
Wide Platform (WP) | 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. | 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). | Southern
Implants
External Hex Implants | |
| CAD/CAM Design
Workflow | 3Shape E3 Desktop
Scanner (3Shape
A/S). 3Shape
Abutment Designer
Software (Shape
A/S)- K151455 | 3Shape Intra oral
scanner Trios
(3Shape A/S). 3Shape
Abutment Designer
Software (Shape
A/S)- K151455 | 3M Tru-Definition, ITero
Scanner 3Shape
Abutment Designer
Software (3Shape A/S) -
K151455 | Sirona software – inlab
15.0 and above Sirona
software - CEREC 4.4
and above | | |
| CAD/CAM
Manufacturing
Workflow | WorkNC CAM
software, Roland
DWX51D milling
unit | CORITEC milling
unit (imes-icore) | Wieland-Zenotec Select
& Zenotec CAM | CEREC MCXL
product family | | |
| Mechanical Testing | Dynamic Fatigue
Testing per ISO
14801 | Dynamic Fatigue
Testing per ISO
14801 | Dynamic Fatigue Testing
per ISO 14801 | Dynamic Fatigue
Testing per ISO 14801 | Dynamic Fatigue
Testing per ISO 14801 | |
| Titanium
Abutment Material | Titanium Grade 5
Alloy (ASTM
F136) | Titanium Vanadium
Alloy (ASTM F136) | Titanium | TiBase - Titanium
6AL4V | Titanium Grade 5
Alloy (ASTM F136) | |
| Abutment Surface
Treatment | Machined and
Anodized gold | | Abutments are titanium
anodized gold and pink
(grooves are machined for
cement adhesion). | Cemented surfaces are
blasted with aluminum
oxide. | Anodized, Grooved | |
| Screw Material | Titanium Grade 5
(ASTM F136) | Titanium | Titanium | Titanium | Titanium Grade 5
(ASTM F136) | |
| Sterility | Supplied non-
sterile | Supplied non-sterile | Supplied non-sterile | Supplied non-sterile | Supplied sterile | |
| Use | Single-Use | | Single-Use | Single-Use | Single-Use | |
| Indications for Use | The TIB
Abutments are
premanufactured
prosthetic
components directly
connected to
endosseous dental
implants and are
intended for use as
an aid in
prosthetic
rehabilitation. The
TIB abutments | The Universal Base
Abutments are
premanufactured
prosthetic
components directly
connected to
endosseous dental
implants and are
intended for use as
an aid in prosthetic
rehabilitation. The
Universal Base | 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 | 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 | Southern Implants'
External Hex Implants
are intended for
surgical placement in
the upper or lower
jaw to provide a means
for prosthetic
attachment of crowns,
bridges or overdentures
utilizing delayed or
immediate loading. | |
| Characteristics | Subject Abutment | Primary Predicate | Reference Predicates | | | |
| | Southern
Implants
TIB
Abutment | Universal
Base
Abutment
(K180899) | InterActive
SMARTBase
Abutments (K181359) | Sirona
Dental
CAD/CAM
System
(K111421) | Southern
Implants'
External
Hex
(K163634) | |
| | consists of two
major parts.
Specifically, the
titanium base and
mesostructure
components make
up a two-piece
abutment.
The system
integrates
multiple
components of the
digital dentistry
workflow: Scan
files from desktop
scanners, CAD
software, CAM
software, ceramic
material, milling
machine and
associated tooling
and accessories. | two major parts.
Specifically, the
titanium base and
mesostructure
components make up
a two-piece abutment.
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. | 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
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. | 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. | Southern Implants'
External Hex Implants
are intended for
immediate function
when good
primary stability with
appropriate occlusal
loading is achieved. | |
6
7
The Indications for Use Statement for the subject device is the same as that of the primary predicate device
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The primary predicate and the subject device have the identical maximum angulation for t restoration and follow an equivalent design workflow. In the design workflow the primary predicate uses a different scanner but the same software to design the restoration. The design workflow differing with the scanner does not impact demonstrating substantial equivalence. The difference in scanner was shown to not affect substantial equivalence by way of software validation, scanning and milling validation, and static and dynamic compression-bending according to ISO 14801.
The subject device is also substantially equivalent to the primary predicate with reference to the abutment's restoration material with the subject and the primary predicate both making use of a ceramic composite riate performance testing on the ceramic component of the two-piece abutment. The both the subject device and primary predicate is a um Allov (ASTM
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F136), the screw material is Titanium for both the subject and primary predicate. Both the subject and the primary predicate devices are provided non-sterile. Thus, the abutment materials and method provided of the subject device are substantially equivalent to that of the primary predicate. The different manufacturing and ceramic material comparison were addressed with biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1. "Biological evaluation of medical devices – Partly Evaluation and testing within a risk management process", and validated sterilization instructions per the FDA Guidance Document for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling.
The reference predicate K181359 is for substantial equivalence of the Subject Device screw thread, manufacturing workflow, abutment surface treatment and usage. The subject device makes use of the same screw threads as the reference device (K181359) with a difference of the 1-72 unf-2b (1.85mm) and M1.8 screw threads. The screw threads differing with the addition of intermediary screw threads does not impact demonstrating substantial equivalence, and this was shown with static and dynamic compression-bending according to ISO 14801.
In terms of the manufacturing workflow, the subject device makes use of the WorkNC CAM software and a Roland DWX51D milling unit. The reference device (K181359) Makes use of Zenotec CAM and Wieland-Zenotec Select milling unit. While both are different brands, both devices make use of CAM software, communicating with a milling unit. The manufacturing workflow differing with CAM software and milling unit brands does not impact demonstrating substantial equivalence, and this was shown by of software validation, scanning and milling validation, and dynamic compression-bending according to ISO 14801.
The reference device (K163634) is for substantial equivalence of abutment material, surface treatment and packaging methods. The subject device abutments are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by anodizing. The anodization process is the same as that used for the reference device (K163634). Both the subject and the reference device are packaged with the same methods for single use. Thus, the material, surface treatment and packaging methods of the subject device is considered substantially equivalent to that of the reference device.
The reference predicate K111421 is for substantial equivalence of the compatible implant platforms. The subject device is designed to connect directly to the Southern Implants External Hex, Deep Conical and Tri-Nex connection types. While the reference device (K111421) is designed to connect directly to multiple different implant systems, which together encompass the same range of implant platform types as that of the subject device. This, with the addition of Mechanical ISO 14801 Fatigue Testing of all four implant platforms proves substantial equivalence of the compatible implant platforms.
The post height of the subject device is indicated to a minimum of 4.5mm. The primary predicate (K180899) is indicated to a minimum of 5.2mm, while the reference device (K181359) is indicated to a minimum of 4mm. The subject device post height lies between these two predicate minimums and is thus substantially equivalent.
Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that materials are identical in formulation, processing, component interactions, and storage conditions to the predicate devices in K163634. Furthermore, biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1, "Biological evaluation of medical devices – Part1: Evaluation and testing within a risk management process" was performed.
The inclusion of the 3Shape software (K151455) was validated with performance testing per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices.
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Overall the subject device has the following similarities to the predicate devices:
- Has the same intended use
- · Incorporates the same basic design
- · Incorporates the same or very similar materials,
- · Follows the equivalent design and manufacturing workflows,
- · Incorporates the same abutment surface treatment and packaging
- Has a similar fatigue limit
CONCLUSION
The subject device and the primary predicate have the same intended use, except for the different scanner. The subject device and predicate devices all incorporate the same materials and basic design. The subject device and the predicate devices are for substantial equivalence of surface treatment and patient usage, and are provided non-sterile. The subject device and the primary predicate follow the same design and manufacturing CAD/CAM workflows.
The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.