(153 days)
No
The summary describes a dental implant abutment and its integration with a digital dentistry workflow (scanners, CAD/CAM software, milling). There is no mention of AI or ML being used in the device itself or the associated software for design or manufacturing. The software validation focuses on design limitations and library integrity, not AI/ML algorithms.
Yes
The device is described as a "premanufactured prosthetic component directly connected to an endosseous implant" and is "intended for use in prosthetic rehabilitation." This indicates it is used for treatment and restoration of a body part, which falls under the definition of a therapeutic device.
No
Explanation: The device is described as a "premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation." Its function is to facilitate the connection of a mesostructure or crown to an implant, not to diagnose a medical condition.
No
The device description clearly states it is a "dental implant abutment" made of "titanium vanadium alloy," which are physical components, not software. While it integrates with digital workflows and software, the core device itself is hardware.
Based on the provided information, the On1™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "prosthetic rehabilitation" by directly connecting to an endosseous implant. This is a mechanical and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a dental implant abutment, a physical component used in dental restoration.
- 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.
- Input: While it uses scan files from intra-oral scanners, these are used for designing the prosthetic component, not for diagnostic analysis of the scan data itself.
- Performance Studies: The performance studies focus on mechanical properties, biocompatibility, software validation for design, and sterilization, all related to the physical and functional aspects of a prosthetic device. There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.).
In summary, the On1™ device is a dental prosthetic component used in the process of restoring teeth, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The On1™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base, the On1 Universal Abutment, and the mesostructure components make up a multi-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 On1 Universal Abutment is a dental implant abutment which attaches to the On1 Base of the On1 Concept (K161655) and is intended to be used with the current Nobel Biocare dental implants that have the existing internal conical connection.
The On1 Universal Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for either an in-laboratory CAD/CAM system made mesostructure or abutment crown. 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 On1 Universal Abutment is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for the internal conical connection. The On1 Universal 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 where the Implant Libraries are obtained via the 3Shape server in the software
- Restorative Material: Enamic (Vita Zahnfabrik H. Rauter GmbH Co) -K153645
- Milling Unit: CORiTEC, imes-icore milling unit
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 On1 Universal Abutment with a bonded Enamic mesostructure. Results confirmed that the proposed On1 Universal 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 qualify any organic 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 On1 Universal 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: The packaging for the subject device is the same as the predicate (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 text "U.S. Food & Drug Administration" in blue letters.
December 12, 2018
Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887
Re: K181869
Trade/Device Name: On1™ Universal Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: November 8, 2018 Received: November 9, 2018
Dear Charlemagne Chua:
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.
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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.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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
Tina Kiang, Ph.D. for 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) K181869
Device Name On1™ Univeral Abutment
Indications for Use (Describe)
The Onl™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The Onl Universal Abutments consist of three major parts. Specifically, the On1 Base, the On1 Universal Abutment, and the mesostructure components make up a multi-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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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: December 11, 2018
II. DEVICE
Name of Device: On1TM Universal 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 K161655, Nobel Biocare AB - On1 Concept
Reference Devices K153645, Vita Zahnfabrik H. Rauter GmbH Co - Vita Enamic® Implant Solutions (IS) 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, Ivoclar Vivadent, Inc. - Multilink Hybrid Abutment Cement
IV. DEVICE DESCRIPTION
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The On1 Universal Abutment is a dental implant abutment which attaches to the On1 Base of the On1 Concept (K161655) and is intended to be used with the current Nobel Biocare dental implants that have the existing internal conical connection.
The On1 Universal Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for either an in-laboratory CAD/CAM system made mesostructure or abutment crown. 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 On1 Universal Abutment is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for the internal conical connection. The On1 Universal 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 where the Implant Libraries are obtained via the 3Shape server in the software
- -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 On1™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consists of three major parts. Specifically, the On1 Base, the On1 Universal Abutment, and the mesostructure components make up a
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multi-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.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI.
| Technological
| characteristics | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|---|---|
| On1 Universal Abutment | On1 Concept | |||||
| (K161655) | VITA ENAMIC IS | |||||
| (K153645) | Sirona Dental CAD/CAM- | |||||
| System (K111421) | InterActive SMARTBase | |||||
| Abutments | ||||||
| (K181359) | ||||||
| Compatible | ||||||
| Implant | ||||||
| Platform | Nobel Biocare Internal | |||||
| Conical Connection |
- Narrow Platform (NP)
- Regular Platform (RP)
- Wide Platform (WP) | Nobel Biocare Internal
Conical Connection - Narrow Platform (NP)
- Regular Platform (RP)
- Wide Platform (WP) | 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). | 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. |
| | Ti/ Abutment
Material | On1 Base (K161655), On1
Universal Abutment -
Titanium vanadium alloy
(ASTM F136) | On1 Base, On1 Esthetic
Abutment Titanium -
Titanium vanadium alloy
(ASTM F136)
On1 Esthetic Abutment
Zirconia - Y-TZP zirconium oxide
(ISO
6872, ISO 13356) | Titanium vanadium alloy
(ISO 5832-3) | Tibase - Titanium 6AL4V | Titanium |
| Design Features | Mesostructure
/
Crown
Material | Enamic (K153645) | N/A | VITA ENAMIC IS, identical
in composition to Enamic
(K153645) | Cercon HT | Zirconia |
| | Mesostructure
/Crown
Fixation | Bonded | N/A | Bonded | Bonded | Bonded |
| | Abutment
Design | 2 piece abutment on On1
Base - Enamic (K153645) | 1 piece abutment on On1
Base - Esthetic Abutment | 2 piece - VITA ENAMIC IS
bonded to Sirona TiBase | The TiBase is a
premanufactured prosthetic | Abutment body consisting
of a titanium base and |
| Technological
characteristics | | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device |
| | | On1 Universal Abutment | On1 Concept
(K161655) | VITA ENAMIC IS
(K153645) | Sirona Dental CAD/CAM-
System (K111421) | InterActive SMARTBase
Abutments
(K181359) |
| | | bonded to the On1
Universal Abutment and
mounted on to the On1
Base (K161655). On1 Base
is mounted on to the
implant and fixed with a
screw. | Titanium is mounted on to
the On1 Base. On1 Base is
mounted on to the implant
and fixed with a screw. | (K111421) mounted on to
the implant and fixed with a
screw | component directly
connected to endosseous
dental implants with a
screw and is intended for
use as an aid in prosthetic
rehabilitation. | supplied with a fixation
screw. The bases are
provided with straight,
angled, and modified
zirconia tops for patient
specific devices. The
devices are also provided
without a zirconia top and a
superstructure or hybrid
crown or bridge can be
milled to fit the bases
intended to be
manufactured at Implant
Direct Manufacturing
facility. |
| | Abutment
Fixation | Screwed | Screwed | Screw or Cement
Retained | Screw or Cement
Retained | Screw Retained |
| | Maximum
Angulation | 20° | 0° | 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 | On1 Universal Abutment | On1 Concept
(K161655) | VITA ENAMIC IS
(K153645) | Sirona Dental CAD/CAM-
System (K111421) | InterActive SMARTBase
Abutments
(K181359) | |
| Indications for Use | The On1™ device is a
premanufactured prosthetic
component directly
connected to an
endosseous implant and it
is intended for use in
prosthetic rehabilitation.
The On1 Universal
Abutments consist of three
major parts. Specifically,
the On1 Base, the On1
Universal Abutment, and
the mesostructure
components make up a
multi-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 | The On1™ device is a
premanufactured prosthetic
component directly
connected to an
endosseous implant and it
is intended for use in
prosthetic rehabilitation. | VITA ENAMIC Implant
Solutions is indicated for
use as a component of a
two-piece abutment
system, consisting of a Ti-
base 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 Ti-base
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 | |
| Technological
characteristics | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | |
| | On1 Universal Abutment | On1 Concept
(K161655) | VITA ENAMIC IS
(K153645) | Sirona Dental CAD/CAM-
System (K111421) | InterActive SMARTBase
Abutments
(K181359)
multiple tooth replacements
or denture stabilization. | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Nobel Biocare Traditional 510(k) Notification On1 Universal Abutment
December 2018
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Analysis of Differences Between Subiect Device and Predicates
The On1 Universal Abutment is a hybrid abutment which connects to the On1 Base of the On1 Concept (K161655). The intended use remains similar. The On1 Universal Abutment is a multi-piece abutment made of titanium vanadium alloy and Enamic (K153645) while the Esthetic abutments of the On1 Concept (K161655) are one-piece, composed either of zirconium oxide or titanium.
The On1 Universal Abutment and reference device VITA ENAMIC IS (K153645) are both abutment systems intended to fit the Nobel Biocare dental implants. Both svstems 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 On1 Universal 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 On1 Universal 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 On1 Universal Abutment and reference device InterActive SMARTBase Abutments (K181359) are both abutment systems intended to fit the Nobel Biocare dental implants. The On1 Universal 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 On1 Universal 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 On1 Universal 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 On1 Universal Abutment is designed to connect directly to the On1 Base which connects to Nobel Biocare dental implants. The placement of the On1 Universal Abutment takes place after placement of the On1 Base and the dental implant. The
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reference device VITA ENAMIC IS (K153645) 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 On1 Universal 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 On1 Universal 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 On1 Universal Abutment is a multi-piece abutment system, consisting of two titanium premanufactured stock components, and a mesostructure or abutment crown which is designed and fabricated with a CAD/CAM workflow. The reference abutments (K153645 and K181359) are also multi-piece abutment systems. consisting of a titanium premanufactured stock component and a mesostructure 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 On1 Universal Abutment with a bonded Enamic mesostructure. Results confirmed that the proposed On1 Universal 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 On1 Universal 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 On1 Universal Abutment was evaluated for substantial equivalence using standard and/or comparative testing. In cases were the On1 Universal 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 On1 Universal Abutment has been shown to be substantially equivalent to the predicates.