(208 days)
No
The summary describes a physical dental abutment and its integration into a standard digital dentistry workflow (scanning, CAD/CAM). There is no mention of AI or ML in the device description, intended use, or performance studies. The software validation focuses on design limitations and compatibility, not AI/ML algorithms.
No.
The document states that 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." This describes a prosthetic device rather than a therapeutic one designed to treat or cure a disease or medical condition.
No.
The device is a dental implant abutment used for prosthetic rehabilitation, not for diagnosing medical conditions.
No
The device description clearly states the device is a physical component (titanium base and mesostructure) and includes mechanical and biocompatibility testing of the physical device. While it integrates with software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for prosthetic rehabilitation by connecting to dental implants. This is a mechanical and structural function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical component (a dental implant abutment) made of titanium vanadium alloy, designed to interface with dental implants and facilitate the creation of a mesostructure. This is a medical device, but not an IVD.
- Lack of Diagnostic Function: 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.
- Workflow: While the workflow involves digital dentistry components like scanners and CAD/CAM, these are tools for designing and fabricating the prosthetic component, not for performing a diagnostic test.
In summary, the Universal Base Abutment is a dental prosthetic component, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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 Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
Product codes (comma separated list FDA assigned to the subject device)
NHA, PNP
Device Description
The Universal Base Abutment is a dental implant abutment intended to be used with the current Nobel Biocare dental implants that have the existing external hex style connections.
The Universal Base Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for an in-laboratory CAD/CAM system made mesostructure. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process.
The Universal Base Abutment is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for external hex. All sizes are available in either 1.5 or 3mm collar heights. The Universal Base Abutment is made of titanium vanadium alloy.
The digital workflow requires the use of the following equipment:
- Scanner: 3Shape intra oral scanner Trios (3Shape A/S) -
- -Design Software: 3Shape Abutment Designer Software (3Shape A/S) -K151455
- Restorative Material: Enamic (Vita Zahnfabrik H. Rauter GmbH Co) --K153645
- Milling Unit: CORiTEC, imes-icore milling unit -
The following restorative design specifications is required:
| Parameter | Specification |
|---|---|
| Angle from axis of the | |
| implant | 20° Max |
| Wall Thickness Circular | 0.8mm min. |
| Wall Thickness Margin | 0.275mm min. |
| Post Height | 5.2mm min. |
| Maximum Length, width and | |
| Height | EM-14 blank 12x14x18mm |
| EM-10 blank 8x10x15mm |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
scan files from Intra-Oral Scanners
Anatomical Site
partially or fully edentulous mandible or maxillae
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)
Mechanical Testing: Worst case dynamic fatigue testing per ISO 14801 demonstrating compliance with the minimum required fatigue properties of the Universal Base Abutment with a bonded Enamic mesostructure. Results confirmed that the proposed Universal Base Abutments were equivalent to the predicate devices.
Biocompatibility Testing: Biological evaluation was conducted according to ISO 10993-1. Cytotoxicity testing per ISO 10993-5 was conducted on the finished devices. GC-MS analysis was performed to gualify any orqanic leachables/ extractables according to CEN EN ISO 10993 12 and CEN EN ISO 10993-18. Results indicate that the devices met biocompatibility requirements for its intended use.
Software Verification and Validation: Validation was completed on the Universal Base Abutment with the 3Shape TRIOS Scanner, 3Shape Abutment Designer Software (K155415), CORiTEC imes-icore milling unit workflow. Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment DesignerTM Software (K151455). Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the mesostructure 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.
Sterilization Validation: The proposed devices are provided non-sterile and intended to be steam sterilized by the end user. Steam sterilization analysis was performed following AAMI-TIR30, ISO 17665-1, and ISO 17665-2.
Device Packaging: Since the subject device does not represent a new worst case in terms of device packaging and shelf life, data from the predicate was leveraged as follows: The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required.
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.
K153645, K111421, K181359, K151455, K130436
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.)
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 1, 2018
Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887
Re: K180899
Trade/Device Name: Universal Base Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: September 26, 2018 Received: September 27, 2018
Dear Charlemagne Chua:
This letter corrects our substantially equivalent letter of October 31, 2018.
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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
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Indications for Use
510(k) Number (if known) K180899
Device Name Universal Base Abutment
Indications for Use (Describe)
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 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 Intra-Oral Scanners, CAD software, 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
A.4.
510(k) Summary
I. SUBMITTER
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348
Date Prepared: October 25, 2018
II. DEVICE
Name of Device: Universal Base Abutment Common or Usual Name: Endosseous Dental Implant Abutment Classification Name: Endosseous Dental Implant (21 CFR 872.3630) Regulatory Class: II Primary Product Code: NHA Secondary Product Code: PNP
III.PREDICATE DEVICE
Primary Predicate K031719. Nobel Biocare - Esthetic Zirconia Abutment
Reference Devices K153645, Vita Zahnfabrik H. Rauter GmbH Co - Vita Enamic® Implant Solutions (lis) K111421, Sirona Dental Systems GmbH – Sirona Dental CAD/CAM System K181359, Implant Direct Sybron Manufacturing Llc - Interactive Smartbase
Abutments
K151455, 3Shape A/S - 3Shape Abutment Designer Software
K130436. Multilink Hybrid Abutment Cement - Ivoclar Vivadent, Inc.
4
IV. DEVICE DESCRIPTION
The Universal Base Abutment is a dental implant abutment intended to be used with the current Nobel Biocare dental implants that have the existing external hex style connections.
The Universal Base Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for an in-laboratory CAD/CAM system made mesostructure. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process.
The Universal Base Abutment is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for external hex. All sizes are available in either 1.5 or 3mm collar heights. The Universal Base Abutment is made of titanium vanadium alloy.
The digital workflow requires the use of the following equipment:
- Scanner: 3Shape intra oral scanner Trios (3Shape A/S) -
- -Design Software: 3Shape Abutment Designer Software (3Shape A/S) -K151455
- Restorative Material: Enamic (Vita Zahnfabrik H. Rauter GmbH Co) --K153645
- Milling Unit: CORiTEC, imes-icore milling unit -
| Restorative design specifications for Universal Base | |
|---|---|
| Parameter | Specification |
| Angle from axis of the | |
| implant | 20° Max |
| Wall Thickness Circular | 0.8mm min. |
| Wall Thickness Margin | 0.275mm min. |
| Post Height | 5.2mm min. |
| Maximum Length, width and | |
| Height | EM-14 blank 12x14x18mm |
| EM-10 blank 8x10x15mm |
The following restorative design specifications is required:
V. INDICATIONS FOR USE
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 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
5
dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
6
VI. Comparison of Technological Characteristics
| Technological
| characteristics | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|---|---|
| Universal Base Abutment | Esthetic Zirconia Abutment | |||||
| (K031719) | VITA ENAMIC IS | |||||
| (K153645) | Sirona Dental CAD/CAM- | |||||
| System (K111421) | InterActive SMARTBase | |||||
| Abutments | ||||||
| (K181359) | ||||||
| Compatible | ||||||
| Implant | ||||||
| Platform | Nobel Biocare | |||||
| External Hex | ||||||
| Narrow Platform (NP) | ||||||
| Regular Platform (RP) | ||||||
| Wide Platform (WP) | Nobel Biocare | |||||
| Internal Tri -Channel | ||||||
| Narrow Platform (NP) | ||||||
| Regular Platform (RP) | ||||||
| Wide Platform (WP) | ||||||
| External Hex | ||||||
| Narrow Platform (NP) | ||||||
| Regular Platform (RP) | ||||||
| Wide Platform (WP) | Nobel Biocare | |||||
| Internal Tri-Channel | ||||||
| Narrow Platform (NP) | ||||||
| Regular Platform (RP) | ||||||
| Wide Platform (WP) | ||||||
| 6.0 | ||||||
| External Hex | ||||||
| Narrow Platform (NP) | ||||||
| Regular Platform (RP) | ||||||
| Internal Conical Connection | ||||||
| Narrow Platform (NP) | ||||||
| Regular Platform (RP) | ||||||
| and Table 1 of K153645 | 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). | 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. | ||||||
| Design Features | Ti-base | |||||
| Material | Titanium vanadium alloy | |||||
| (ASTM F136) | Metal adapter for Internal | |||||
| Tri-Channel: CP titanium | ||||||
| grade 1 (ASTM F67) | Titanium vanadium alloy | |||||
| (ISO 5832-3) | Tibase - Titanium 6AL4V | Titanium | ||||
| Mesostructure | ||||||
| / | ||||||
| Crown | ||||||
| Material | Enamic (K153645) | Y-TZP zirconium oxide (ISO |
-
| VITA ENAMIC IS, identical in
composition to Enamic
(K153645) | Cercon HT | Zenostar MT |
| | Abutment
Design | 2 piece - Enamic
(K153645) bonded to
Universal Base Abutment
mounted on to the implant
and fixed with a screw | External Hex: Single piece
with fixed upper shape
Internal Tri-Channel: Single
piece with fixed upper shape
and Metal adapter | 2 piece - VITA ENAMIC IS
bonded to Sirona TiBase
(K111421) mounted on to
the implant and fixed with a
screw | 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. | 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 |
| Technological
characteristics | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | |
| | Universal Base Abutment | Esthetic Zirconia Abutment
(K031719) | VITA ENAMIC IS
(K153645) | Sirona Dental CAD/CAM-
System (K111421) | InterActive SMARTBase
Abutments
(K181359) | |
| | Abutment
Fixation | Screwed | Screwed | Screwed | Screw or Cement
Retained | Screw Retained |
| | Maximum
Abutment
Angulation | 20° | No angulation | 20° | 20° | 30° |
| | Design
Workflow | 3Shape intra oral scanner
Trios (3Shape A/S),
3Shape Abutment
Designer Software
(3Shape A/S) - K151455 | Traditional workflow | Sirona software - inlab 15.0
and above
Sirona software - CEREC
4.4 and above | Sirona software - inlab 15.0
and above
Sirona software - CEREC
4.4 and above | 3M Tru-Definition, ITero
Scanner
3Shape Abutment Designer
Software (3Shape A/S) -
K151455 |
| | Manufacturing
Workflow | CORITEC milling unit
(imes-icore) | Traditional workflow | Sirona CEREC milling
systems | Sirona CEREC milling
systems | Wieland-Zenotec Select &
Zenotec CAM |
| | 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 |
| | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | |
| Technological
characteristics | Universal Base Abutment | Esthetic Zirconia Abutment
(K031719) | VITA ENAMIC IS
(K153645) | Sirona Dental CAD/CAM-
System (K111421) | InterActive SMARTBase
Abutments
(K181359) | |
| Indications for Use | 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
Abutments consist of two
major parts. Specifically,
the titanium base and
mesostructure
components make up a
two-piece abutment.
he 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. | Nobel Biocare's Esthetic
Zirconia Abutment is
indicated for the treatment of
partially edentulous patients
requiring prosthetic devices
and/or endosseous implants
to restore chewing function | VITA ENAMIC Implant
Solutions is indicated for use
as a component of a two-
piece abutment system,
consisting of a Tibase
component, and a
mesostructure or abutment
crown. VITA ENAMIC
Implant Solutions is intended
for use in partially or fully
edentulous mandible or
maxillae for fabrication of
permanent, anterior or
posterior, single unit
CAD/CAM abutments. VITA
ENAMIC Implant Solutions is
indicated for use in
conjunction with the
CAD/CAM component of the
Sirona Dental CAD/CAM
system and the following
Tibase abutments and
implant bodies: (Table 1 of
K153645) | 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. | 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 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. | |
Nobel Biocare Traditional 510(k) Notification Universal Base Abutment
7
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9
Analysis of Differences Between Subiect Device and Predicates
The Universal Base Abutment and Esthetic Zirconia Abutment primary predicate (K031719) are intended to be used with the same existing Nobel Biocare dental implant connection external hex style connection. The Universal Base Abutment is a two-piece abutment made of titanium vanadium alloy and Enamic (K153645) while the primary predicate K031719 is a one-piece. composed of zirconium oxide, or two-piece abutment/crown, composed of CP titanium and zirconium oxide, depending on the implant connection.
The Universal Base Abutment and reference device VITA ENAMIC IS (K153645) are both abutment systems intended to fit the Nobel Biocare dental implants. Both systems consist of a titanium abutment component and a mesostructure or abutment crown composed of Enamic (K153645) material. Furthermore, both svstems feature a screwed abutment fixation. The Universal Base Abutment allows for a maximum abutment angulation correction of 20 degrees as the reference device VITA ENAMIC IS (K153645) which also allows for a maximum abutment angulation correction of 20 degrees. Furthermore, both systems are intended for CAD/CAM workflows. The reference device K153645 utilizes the Sirona Dental CAD/CAM-System (K111421) which includes scanner, software and mill to manufacture the Enamic (K153645) mesostructure. The Universal Base Abutment utilizes a 3shape TRIOS intraoral scanner, 3Shape Abutment Designer Software (3Shape A/S) - K151455) and a CORiTEC imes-icore milling unit to produce the mesostructure.
The Universal Base Abutment and reference device InterActive SMARTBase Abutments (K181359) are both abutment systems intended to fit the Nobel Biocare dental implants. The Universal Base Abutment consist of a titanium abutment component and a mesostructure or abutment crown composed of Enamic (K153645) material. The InterActive SMARTBase Abutments (K181359) consists of a titanium abutment component and a mesostrucutre or abutment crown composed of Zirconia. Both systems feature a screwed abutment fixation. The Universal Base Abutment allows for a maximum abutment angulation correction of 20 degrees and the the reference device InterActive SMARTBase Abutments (K181359) allows for svstems are intended for CAD/CAM workflows. The reference device K181359 utilizes the 3M Tru-Definition, ITero Scanner, 3Shape Abutment Designer Software (3Shape A/S) - K151455) and a Wieland-Zenotec Select and Zenotec CAM unit to produce the Zirconia mesostructure. The Universal Base Abutment utilizes the 3shape TRIOS intraoral scanner, 3Shape Abutment Designer Software (3Shape A/S) - K151455) and a CORiTEC imes-icore milling unit to produce the mesostructure.
Compatible Implant Platforms
The Universal Base Abutment is designed to connect directly to the Nobel Biocare dental implants. The placement of the Universal Base Abutment takes place after placement of the dental implant. The reference device VITA ENAMIC IS (K153645)
10
Ti-base is intended to be connected directly to the implant. Unlike the subject device where it is intended to be used with Nobel Biocare dental implants only, the predicate VITA ENAMIC IS (K153645) is intended to be used with Nobel Biocare dental implants as well as other implants made by non-Vita manufacturers.
Design Workflow
The design and fabrication of the Enamic (K153645) restorations to be bonded to the Universal Base Abutment will be conducted using the following workflow: 3shape TRIOS intraoral scanner, 3Shape Abutment Designer Software (3Shape A/S) - K151455) and a CORiTEC imes-icore milling unit. The reference device InterActive SMARTBase Abutments (K181359) utilizes a different scanner but the same software to design the restoration.
Manufacturing Workflow
The manufacturing of the Enamic (K153645) restorations to be bonded to the Universal Base Abutment will be milled with a CORiTEC imes-icore milling unit. The reference device InterActive SMARTBase Abutments (K181359) utilizes Wieland-Zenotec Select and Zenotec CAM to produce the milled abutment component. The workflow which includes the 3shape TRIOS oral scanner, 3Shape Abutment Designer Software (3Shape A/S) - K151455) and the CORiTEC imes-icore milling machine. The manufacturing workflow differing with the milling unit does not impact demonstrating the substantial equivalence of the subject device to the predicates.
Indications for Use
The intended use for both the subject and predicate device are in the table above. The Universal Base Abutment is a two-piece abutment system, consisting of a titanium premanufactured stock component, and a mesostructure or abutment crown which is designed and fabricated with a CAD/CAM workflow. The reference abutments (K153645 and K181359) are also two-piece abutment systems, consisting of a titanium premanufactured stock component and a mesostructured or abutment crown which is fabricated with a CAD/CAM workflow. The difference does not impact demonstrating the substantial equivalence of the subject device to the predicates.
Summary:
The design differences between the subject and predicates do not raise different questions of substantial equivalence. Differences in technology were evaluated through performance testing.
VII. PERFORMANCE DATA
The following performance testing was submitted in this 510(k) to support substantial equivalence:
Mechanical Testing
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Worst case dynamic fatigue testing per ISO 14801 demonstrating compliance with the minimum required fatigue properties of the Universal Base Abutment with a bonded Enamic mesostructure. Results confirmed that the proposed Universal Base Abutments were equivalent to the predicate devices.
Biocompatibility Testing
Biological evaluation was conducted according to ISO 10993-1. Cytotoxicity testing per ISO 10993-5 was conducted on the finished devices. GC-MS analysis was performed to gualify any orqanic leachables/ extractables according to CEN EN ISO 10993 12 and CEN EN ISO 10993-18. Results indicate that the devices met biocompatibility requirements for its intended use.
Software Verification and Validation
Validation was completed on the Universal Base Abutment with the 3Shape TRIOS Scanner, 3Shape Abutment Designer Software (K155415), CORiTEC imes-icore milling unit workflow. Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment DesignerTM Software (K151455). Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the mesostructure 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.
Sterilization Validation
The proposed devices are provided non-sterile and intended to be steam sterilized by the end user. Steam sterilization analysis was performed following AAMI-TIR30, ISO 17665-1, and ISO 17665-2.
Device Packaging
Since the subject device does not represent a new worst case in terms of device packaging and shelf life, data from the predicate was leveraged as follows: The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required.
VIII. CONCLUSIONS
The Universal Base Abutment was evaluated for substantial equivalence using standard and/or comparative testing. In cases were the Universal Base Abutment could be demonstrated as not to represent the worst-case with respect to the predicates, data from these predicate devices was leveraged to support the subject device. Based on technological characteristics and non-clinical test data included in this submission, the Universal Base Abutment has been shown to be substantially equivalent to the predicates.