Predicate Devices

Reference Devices

K192614, K240208, K163194, K180536, K201225, K071370, K083205, K142260, K173961, K181703, K191256, K210855, K212533, K072589, K061410

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical dental abutment and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical and biological properties.

Therapeutic

No
The device is a prosthetic component used to support prostheses, not a therapeutic device.

Diagnostic

No

Explanation:
The device description clearly states "The Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation." It further describes it as a "transmucosal abutment used to support screw-retained prostheses." These functions are entirely prosthetic (replacement of missing body parts) and do not involve diagnosing a condition, disease, or its severity.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, pre-manufactured prosthetic component made of Ti-6Al-4V alloy, intended for direct connection to a dental implant. The performance studies focus on physical and mechanical testing of this hardware. There is no mention of software as a component or function of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states it's a "pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation." This describes a device used in vivo (within the body) for structural support and prosthetic attachment, not for testing samples in vitro (outside the body) to diagnose or monitor a medical condition.
Device Description: The description details a physical component (abutment) that connects to a dental implant and supports a prosthesis. It describes its material, how it's used in a dental procedure, and its physical characteristics. This aligns with a medical device used for treatment or rehabilitation, not a diagnostic test.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information about a patient's health status. The device's function is purely mechanical and structural.

Therefore, the Omnibut is a dental prosthetic component, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function with four or more endosseous implants, are indicated for multiple unit reconstructions when screw-retained prosthetics are preferred.

Product codes (comma separated list FDA assigned to the subject device)

NHA

Device Description

The Omnibut™ is a transmucosal abutment used to support screw-retained prostheses on four or more implants. The subject device has a premanufactured connection for the platforms listed in Table 1 Compatible Implant Systems.

The system involves a ball abutment attached to an implant. A retention attachment allows for angle corrections of up to 30° off the implant axis. The ball abutment is inserted into the attachment is adjusted to the desired angle using an orientation screw. The abutment supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. Finally, the prostheses are retained to the abutment by prosthetic screws.

The subject device abutments and system components are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. The subject device is a single use device is provided nonsterile and intended to be sterilized by the user prior to placement in the patient.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper or lower jaw

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing performed on the subject device to demonstrate substantial equivalence included:

reverse engineering dimensional analysis (of OEM implant bodies, OEM abutments, and OEM abutment screws) to demonstrate the subject device abutments are compatible with the Neodent GM Helix (Morse Taper GM connection) implants, the Nobel Internal (Conical Connection) implants, Straumann BLX (TorcFit™ Internal Hexalobular connection) implants, and Zimmer Internal (Internal Hex connection) implants;
dynamic load testing conducted according to ISO 14801:2016 to support the performance of the subject device abutments with the Neodent GM Helix (Morse Taper GM connection) implants, the Nobel Internal (Conical Connection) implants, Straumann BLX (TorcFit™ Internal Hexalobular connection) implants, and Zimmer Internal Hex connection) implants;
non-clinical analysis to evaluate the subject device in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021) including magnetically induced displacement force and torque;
moist heat sterilization for subject devices provided non-sterile to the end user, validated to a sterility assurance level of 10-6 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2;
Verification of biocompatibility of the final device in accordance with ISO 10993-1 and ISO 10993-5;
Bench testing included Retention Force Testing and Simulated Use Testing.
Simulated cleaning testing to show the cleanability of the Omnibut vs a predicate device.

Key results summary:

Standard	Description of Test	Results
Biological Risk Assessment
ISO 10993-1:2018
FDA Guidance on the Use of
ISO 10993-1, 2023	Biological Evaluation of Medical
Devices – Part 1: Evaluation and
Testing within a Risk
Management Process	All biological endpoint testing performed
on the device, along with the analysis on
the physical and chemical information,
returned passing results. All biological
endpoint testing suggests that the Omnibut
is biocompatible and does not present a
foreseen biological risk to those patient
populations it is intended for.
Cytotoxicity
ISO 10993-5 (2009)	Biological Evaluation of Medical
Devices – Part 5: Tests for in
vitro cytotoxicity	The test article showed no evidence of
causing cell lysis or toxicity. The test article
met the requirements of the test since the
grade was grade 0 (no reactivity).
Sterilization Validation
Testing per standards:
• AAMI TIR12:2020
• ANSI/AAMI/ISO 17665-
1:2026/(R)2013
• ANSI/AAMI ST79:2017	AAMI TIR12:2020 Designing,
Testing, And Labeling Medical
Devices Intended For Processing
By Health Care Facilities: A Guide
For Device Manufacturers,
Overkill method according to
Section 5.7	PASS – Results from testing have
demonstrated that the Omnibut was able
to achieve a 10-6 SAL when using the
recommended parameters in the
Instructions for Use (IFU).
Dynamic Fatigue Testing
Testing per ISO 14801:2016
FDA Guidance Document,
"Class II Special Controls
Guidance Document: Root-form Endosseous Dental
Implants and Endosseous
Dental Abutments" (May 12, 2004)	ISO 14801:2016: Dentistry —
Implants — Dynamic loading test
for endosseous dental implants

Root-form Endosseous Dental
Implants and Endosseous Dental
Abutments - Class II Special
Controls Guidance Document for
Industry and FDA Staff Section 8 | PASS – The results conclude that when
evaluated in a manner consistent with ISO
14801:2016, the Omnibut met all
predetermined acceptance criteria. |
| Compatibility
FDA Guidance Document,
"Class II Special Controls
Guidance Document: Root-form Endosseous Dental
Implants and Endosseous
Dental Abutments" (May 12, 2004) | Reverse engineering dimensional
analysis of OEM implant bodies,
OEM abutments, and OEM
abutment screws were
performed to demonstrate that
the Omnibut abutments are
compatible with the noted
implant systems.

Compatibility must be
demonstrated to ensure proper
device functionality. | PASS – The engineering and dimensional
analysis concluded that each Omnibut
design is compatible with the applicable
implant connection.

PASS - Omnibut prosthetic side
components were demonstrated to be
compatible. |
| Retention Force Testing | The Omnibut has a retention
attachment. Retention Force
testing was performed via
tensile push-out to ensure that
the attachment will not detach
during clinical use. | PASS - The Omnibut retention attachment
did not detach at a predetermined
acceptable force. |
| Simulated-Use Testing | Simulated Use of four Omnibuts
with components connected to a
Titanium Bar under a clinically
relevant cyclic load. | PASS - The Omnibut and components did
not yield, deform, or fracture after fatigue
testing. |
| Simulated Cleaning Testing | Simulated cleaning of Omnibuts
in a fixture with a clinically worst
case cleansibility construction. | PASS - All parts of the Omnibuts were
clean of soil indicators after six soilage and
cleaning cycles. |

Clinical performance data is not required to establish substantial equivalence for the subject devices.

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.

K161416

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.

K192614, K240208, K163194, K180536, K201225, K071370, K083205, K142260, K173961, K181703, K191256, K210855, K212533, K072589, K061410

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

Regulation Number and Section

§ 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.)

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 17, 2025

Smart Denture Conversions, LLC % Azary Joseph Regulatory Consultant Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, Connecticut 06484

Re: K242064

Trade/Device Name: Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 12, 2024 Received: December 19, 2024

Dear Azary Joseph:

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 (the 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 available 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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

2

3

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,

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K242064

Device Name

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)

Indications for Use (Describe)

The Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

| Compatible Implant System

(Connection)	Implant Body Diameter, mm	Implant Platform, mm
Neodent Helix
(Morse taper GM)	3.5,3.75, 4.0, 4.3, 5.0, 6.0, 7.0	GM (3.0)
NobelActive®
(Conical Connection)	3.5	NP (3.5)
	4.3, 5.0	RP (3.9)
Straumann BLX
(TorcFit™ Internal Hexalobular)	3.5, 3.75, 4.0, 4.5	RB
	5.0, 5.5, 6.5	WB
Tapered Screw-Vent®
(Zimmer Internal Hex)	3.7, 4.1	3.5
	4.7	4.5
	6	5.7

Table 1 - Compatible Implant Systems

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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4

510(k) Summary

K242064

Smart Denture Conversions, LLC

Omni-Directional Multi-Unit Abutment System

January 14, 2025

ADMINISTRATIVE INFORMATION

Manufacturer Name	Smart Denture Conversions, LLC
	1800 N. Salem St., Suite 104
	Apex, NC 27523
FDA Registration	3015527825
Telephone	(855) 550-0707
Representative/Consultant	Joseph Azary
	Aztech Regulatory & Quality LLC
	543 Long Hill Ave
	Shelton, CT 06484
	Telephone (203) 242-6670
	Email jazary@rcn.com

DEVICE NAME AND CLASSIFICATION

Proprietary Name:	Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)
Common/Usual Name:	Dental Implant Abutment
Regulation Number:	21 CFR 872.3630
Regulation Name:	Endosseous dental implant abutment
Regulatory Class:	Class II
Product code:	NHA
Classification Panel:	Dental
Reviewing Office:	Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT, and
Dental Devices
Reviewing Division:	Division of Dental and ENT Devices

PREDICATE AND REFERENCE DEVICE INFORMATION

Primary Predicate: K161416, NobelActive Multi Unit Plus Abutment, Nobel Biocare AB

Reference Devices:

K192614, Meg-Ball Attachment System, Meg-Magnet Abutment, Meg-Magnet Abutment, MegaGen Implant CO., Ltd. K240208, DESS Dental Smart Solutions, Terrats Medical SL

Reference Devices for OEM Implant Body Clearances K163194, Neodent Implant System – GM Line, JJGC Indústria e Comércio de Materiais Dentários SA K180536, Neodent Implant System – GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A. K201225, Neodent Implant System – GM Helix Implants 7.0, JJGC Indústria e Comércio de Materiais S.A. K071370, Nobelactive Internal Connection Implant, Nobel Biocare AB K083205, Nobelactive 8.5 Mm & 18.0 Mm, Nobel Biocare AB K142260, NobelActive®, Nobel Biocare AB K173961, Straumann® BLX Implant System, Institut Straumann AG

5

510(k) Summary Page 2 of 8

K181703, Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments, Institut Straumann AG

K191256, Straumann BLX Ø3.5 mm Implants, Institut Straumann AG

K210855, Straumann BLX Implant System, Institut Straumann AG

K212533, BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants, Institut Straumann AG

K072589, Tapered Screw-Vent Implant, 4.1mmD, Zimmer Dental, Inc.

K061410, Screw-Vent Implant System, SV, Tapered Screw-Vent Implant System TSV. Advent Implant System AV, Zimmer One Piece Implant, Zimmer Dental (includes 3.7, 4.7 and 6.0mm diameters)

INTENDED USE/INDICATIONS FOR USE STATEMENT

Indications for Use:

The Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

| Compatible Implant System

(Connection)	Implant Body Diameter, mm	Implant Platform, mm
Neodent Helix
(Morse taper GM)	3.5,3.75, 4.0, 4.3, 5.0, 6.0, 7.0	GM (3.0)
NobelActive®
(Conical Connection)	3.5	NP (3.5)
NobelActive®
(Conical Connection)	4.3, 5.0	RP (3.9)
Straumann BLX
(TorcFit™ Internal Hexalobular)	3.5, 3.75, 4.0, 4.5	RB
Straumann BLX
(TorcFit™ Internal Hexalobular)	5.0, 5.5, 6.5	WB
Tapered Screw-Vent ®
(Zimmer Internal Hex)	3.7, 4.1	3.5
Tapered Screw-Vent ®
(Zimmer Internal Hex)	4.7	4.5
Tapered Screw-Vent ®
(Zimmer Internal Hex)	6	5.7

Table 1 - Compatible Implant Systems

Intended Use:

Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function with four or more endosseous implants, are indicated for multiple unit reconstructions when screw-retained prosthetics are preferred.

SUBJECT DEVICE DESCRIPTION

The Omnibut™ is a transmucosal abutment used to support screw-retained prostheses on four or more implants. The subject device has a premanufactured connection for the platforms listed in Table 1 Compatible Implant Systems.

The system involves a ball abutment attached to an implant. A retention attachment allows for angle corrections of up to 30° off the implant axis. The ball abutment is inserted into the attachment is adjusted to the desired angle using an orientation screw. The abutment supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. Finally, the prostheses are retained to the abutment by prosthetic screws.

The subject device abutments and system components are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. The subject device is a single use device is provided nonsterile and intended to be sterilized by the user prior to placement in the patient.

6

PERFORMANCE DATA

Non-clinical testing performed on the subject device to demonstrate substantial equivalence included:

provided in this submission is reverse engineering dimensional analysis (of OEM implant bodies, OEM abutments, and OEM abutment screws) to demonstrate the subject device abutments are compatible with the Neodent GM Helix (Morse Taper GM connection) implants, the Nobel Internal (Conical Connection) implants, Straumann BLX (TorcFit™ Internal Hexalobular connection) implants, and Zimmer Internal (Internal Hex connection) implants;
provided in this submission is dynamic load testing conducted according to ISO 14801:2016 to support the performance of the subject device abutments with the Neodent GM Helix (Morse Taper GM connection) implants, the Nobel Internal (Conical Connection) implants, Straumann BLX (TorcFit™ Internal Hexalobular connection) implants, and Zimmer Internal Hex connection) implants;
provided in this submission was non-clinical analysis to evaluate the subject device in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021) including magnetically induced displacement force and torque;
. provided in this submission is moist heat sterilization for subject devices provided non-sterile to the end user, validated to a sterility assurance level of 10° by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2;
Verification of biocompatibility of the final device in accordance with ISO 10993-1 and ISO 10993-5;
Bench testing included Retention Force Testing and Simulated Use Testing.
Simulated cleaning testing to show the cleanability of the Omnibut vs a predicate device.

Table 2 – Summary of Performance Data
Standard	Description of Test	Results
Biological Risk Assessment
ISO 10993-1:2018
FDA Guidance on the Use of
ISO 10993-1, 2023	Biological Evaluation of Medical
Devices – Part 1: Evaluation and
Testing within a Risk
Management Process	All biological endpoint testing performed
on the device, along with the analysis on
the physical and chemical information,
returned passing results. All biological
endpoint testing suggests that the Omnibut
is biocompatible and does not present a
foreseen biological risk to those patient
populations it is intended for.
Cytotoxicity
ISO 10993-5 (2009)	Biological Evaluation of Medical
Devices – Part 5: Tests for in
vitro cytotoxicity	The test article showed no evidence of
causing cell lysis or toxicity. The test article
met the requirements of the test since the
grade was grade 0 (no reactivity).
Sterilization Validation
Testing per standards:
• AAMI TIR12:2020
• ANSI/AAMI/ISO 17665-
1:2026/(R)2013
• ANSI/AAMI ST79:2017	AAMI TIR12:2020 Designing,
Testing, And Labeling Medical
Devices Intended For Processing
By Health Care Facilities: A Guide
For Device Manufacturers,
Overkill method according to
Section 5.7	PASS – Results from testing have
demonstrated that the Omnibut was able
to achieve a 10-6 SAL when using the
recommended parameters in the
Instructions for Use (IFU).
Dynamic Fatigue Testing	Dynamic Fatigue testing per:	PASS – The results conclude that when
Testing per ISO 14801:2016

FDA Guidance Document,
"Class II Special Controls
Guidance Document: Root-form Endosseous Dental
Implants and Endosseous
Dental Abutments" (May 12, 2004) | ISO 14801:2016: Dentistry —
Implants — Dynamic loading test
for endosseous dental implants

Root-form Endosseous Dental
Implants and Endosseous Dental
Abutments - Class II Special
Controls Guidance Document for
Industry and FDA Staff Section 8 | evaluated in a manner consistent with ISO
14801:2016, the Omnibut met all
predetermined acceptance criteria. |
| Compatibility | Reverse engineering dimensional
analysis of OEM implant bodies,
OEM abutments, and OEM
abutment screws were
performed to demonstrate that
the Omnibut abutments are
compatible with the noted
implant systems.

Compatibility must be
demonstrated to ensure proper
device functionality. | PASS – The engineering and dimensional
analysis concluded that each Omnibut
design is compatible with the applicable
implant connection.

PASS - Omnibut prosthetic side
components were demonstrated to be
compatible. |
| FDA Guidance Document,
"Class II Special Controls
Guidance Document: Root-form Endosseous Dental
Implants and Endosseous
Dental Abutments" (May 12, 2004) | | |
| Retention Force Testing | The Omnibut has a retention
attachment. Retention Force
testing was performed via
tensile push-out to ensure that
the attachment will not detach
during clinical use. | PASS - The Omnibut retention attachment
did not detach at a predetermined
acceptable force. |
| No standard | | |
| Simulated-Use Testing | Simulated Use of four Omnibuts
with components connected to a
Titanium Bar under a clinically
relevant cyclic load. | PASS - The Omnibut and components did
not yield, deform, or fracture after fatigue
testing. |
| No standard | | |
| Simulated Cleaning Testing | Simulated cleaning of Omnibuts
in a fixture with a clinically worst
case cleansibility construction. | PASS - All parts of the Omnibuts were
clean of soil indicators after six soilage and
cleaning cycles. |
| No standard | | |

of Dorform

7

Clinical performance data is not required to establish substantial equivalence for the subject devices.

EQUIVALENCE TO MARKETED DEVICES

The subject device abutments are substantially equivalent in intended use to the primary predicate device K161416, and the reference devices K192614 and K240208. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible.

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The primary predicate device K161416 and the reference devices K192614 and K240208 are in support of the substantial equivalence of the subject device designs, material, manufacturing, and biocompatibility.

All subject device abutments have identical materials as the predicate device is different in technology compared to the predicate, as it has a variable angulation and differently designed components. The device has many common characteristics with the predicate and reference devices as found in 510(k)sK161416, K192614, and K240208. The subject submission, K161416, K192614, and K240208 all include abutments manufactured from Ti-6Al-4V alloy conforming to ASTM F136. The scientific data described above demonstrates that the subject device has equivalent performance compared to the predicate device.

The subject device abutments have similar or identical ranges of abutment-implant platform diameter, prosthetic platform diameter, and angulation as the components cleared in K161416, K192614, and K240208.

The subject device abutments and the reference device K240208 include abutments compatible with the Reference Devices for OEM Implant Body Clearances above.

The subject device abutments and the reference device K240208 include non-sterile provided devices.

The risks associated with the use of the subject device abutment angulation with the compatible implants are mitigated by the mechanical testing as described in the performance testion of this summary.

CONCLUSION

Any differences in the technological characteristics between the subject device, the predicate device, and reference devices do not raise different questions of safety or effectiveness. The data included in this submission demonstrate substantial equivalence to the predicate and reference devices listed above.

Overall, the subject devices have the following similarities to the primary predicate and reference devices:

Have similar intended use,
Use similar operating principles,
Incorporate identical materials,
Are sterilized using similar materials and processes,
And have similar packaging

The basis for the belief of Smart Denture Conversions, LLC that the subject device is substantially equivalent to the predicate devices is summarized in the following Table 3, Substantial Equivalence.

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Table 3 – Substantial Equivalence

| Descriptive

Information	Subject Device	Primary Predicate	Reference Device #1	Reference Device #2	Comparison
	Omni-Directional Multi-
Unit Abutment System

Smart Denture
Conversions | K161416
Multi-unit Abutment Plus

Nobel Biocare AB | K192614
Meg-Ball Attachment System,
Meg-Loc Abutment, Meg-Magnet
Abutment

MegaGen Implant CO., Ltd. | K240208
DESS Dental Smart Solutions

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510(k) Summary Page 7 of 8

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