Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental implant and its materials, design features, and performance testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.

Therapeutic

Yes
The device is intended to restore masticatory function by providing support for artificial teeth, which can be considered a therapeutic benefit.

Diagnostic

No.
This device is a dental implant system used to provide support for prosthetic devices, restoring masticatory function. It is a treatment device, not one that gathers information about a patient's health state for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly details physical hardware components made of titanium alloy, including implants and cover screws, and describes their physical properties and testing. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the device is "surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices... in order to restore masticatory function." This describes a surgical implant for structural support, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The description details the physical characteristics, materials, and function of a dental implant and cover screw. It focuses on mechanical properties, surgical procedures, and integration with bone and prosthetic devices. There is no mention of analyzing biological samples or providing diagnostic information.
Performance Studies: The performance studies described focus on mechanical testing (fatigue), biocompatibility, sterilization, packaging integrity, and magnetic resonance compatibility. These are typical tests for implantable medical devices, not IVDs.
Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There are no references to diagnostic markers, assays, or laboratory procedures.

In summary, the device is a surgically implanted medical device designed to provide structural support for dental prosthetics, not a device used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

MIS Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

Product codes

DZE, NHA

Device Description

The proposed MIS LYNX Conical Connection Dental Implants are intended for one- or two-stage dental implant procedures and are used in the upper or lower jaw for supporting tooth replacement to restore chewing function.

The proposed dental implants have an internal conical connection with an anti-rotation index of six positions for standard and wide platforms and four positions for narrow platform.

The proposed implants and cover screw are manufactured from titanium alloy (Ti-6A1-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant).

The 3.3 mm diameter size implant is available in 10, 11.5, 13, and 16 mm lengths while the 3.75, 4.2, and 5.0 mm diameter size implants are available in 8, 10, 11.5, 13, and 16 mm lengths.

The proposed implants feature an outer profile which has a coronal half which is cylindrical and an apical half which is conical. The threads are designed so the implant has a self-drilling property. The geometric design also includes spiral channels (flutes) stemming from the apex. These spiral channels are designed to enable insertion torque reduction when applying reverse torque. The proposed implant design also includes circumferential grooves at the coronal area which are called "micro-rings". These horizontal micro-rings are designed to increase the BIC (Bone to Implant Contact) of the implant with the bone. The proposed implants also feature a triangular neck ("V-Cut''). The gaps around the sides of the implant neck are designed to result in an open, compression free zone.

The implant-abutment connection surface of the proposed MIS LYNX Conical Connection Implant is anodized for color coding to indicate the platform: yellow for narrow platform implants, purple for standard platform implants, and green for wide platform implants. The proposed implants are packaged in either a dry or wet package. Implants packaged in the wet packaging configuration are packaged in NaCl solution and are not anodized. The liquid environment is intended to maintain the super-hydrophilic (contact angle exhibited by water in contact with the surface is equal to zero degrees) property of the proposed dental implants until the implants are installed in the patients.

Cover screws are intended to be used in a two-stage surgical procedure as temporary components to the proposed endosseous implant to allow healing of the soft tissue. They are inserted into the implant and the gums are sutured over it. Their purpose is to let the osseointegration begin without any forces being applied to the implant. After a healing period, the cover screw is exposed and removed, and replaced by either a healing cap or an abutment. The cover screws are also anodized for color coding.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper or lower jaw arches

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)

Fatigue testing: Performed according to ISO 14801:2016 and FDA guidance document "Root-form endosseous dental implants and endosseous dental abutments". Key result: confirms that the proposed device is similar or exceeds performance when compared to the predicate device (K172505) and reference (K112162) devices.
Biocompatibility assessment: Performed according to ISO 10993-5:2009, ISO 10993-23:2021, ISO 10993-10:2021, FDA's 2023 Biocompatibility Guidance "Use of International Standard ISO 10993-1," ISO 10993-11:2017, ISO 10993-3:2014, ISO 10993-18:2020, ISO/TS 21726:2019, and ISO 10993-17: 2023. Key result: Biocompatibility profile evaluated.
Dose mapping: Performed according to ISO 11137-1:2006, ISO 11137-3:2017, and ISO/ASTM 52303:2015. Key result: Ensures each routine Gamma irradiation results in a minimum of 20kGy.
Bioburden testing: Performed according to AAMI TIR35:2016 and BS EN ISO 11137-2:2015. Key result: Proposed device included into the existing sterilization.
Sterility testing: Performed according to ISO 11737-2:2019(E). Key result: Packaging maintains sterility after simulated distribution.
Accelerated aging, visual inspection, packaging integrity testing, seal strength testing, "wet" packaging weight loss testing, and hydrophilicity testing: Performed according to ASTM D4169-22, ASTM D4332-22, ASTM F1980-21, ASTM F1929-15, ASTM F2096-11: 2019, ASTM F88/F88M-23, BS EN 868-5:2018, and internal test method. Key result: Test results met acceptance criteria.
Magnetically induced displacement force: According to ASTM F2052-21.
Magnetically induced torque: According to ASTM F2213-17.
Image Artifact: According to ASTM F2119-07 (2013).
RF Induced Heating Simulation: Using Computational modeling and simulation (CM&S).
Key result for Magnetically induced displacement force, torque, image artifact, and RF Induced Heating Simulation: Device labeling for the proposed implants will indicate MRI Conditional.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K172505

Reference Device(s)

K112162, K163349, K200102

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 25, 2024

Dentsply Sirona Inc. Laura Sobrin Sr. Technical Regulatory Affairs Manager 221 West Philadelphia St., Suite 60W York, Pennsylvania 17401

Re: K241692

Trade/Device Name: MIS LYNX Conical Connection Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 12, 2024 Received: October 23, 2024

Dear Laura Sobrin:

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

For comprehensive regulatory information about mediation-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

Submission Number (if known)

K241692

Device Name

MIS LYNX Conical Connection Implant System

Indications for Use (Describe)

MIS Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant mav be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

Type of Use (Select one or both, as applicable)

rescription Use (Part 21 CFR 801 Subpart D)

The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

for

MIS LYNX Conical Connection Implant System (K241692)

Submitter Information: 1.
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401, USA

Contact Person:	Laura Sobrin
Telephone Number:	717-849-4434
Email:	laura.sobrin@dentsplysirona.com
Date Prepared:	November 25, 2024

1. Device Name:
  ●
Proprietary Name: . MIS LYNX Conical Connection Implant System
- Classification Name: Implant, Endosseous, Root-Form
CFR Number: 872.3630 .
. Device Class: Class II
Primary Product Code: DZE
Secondary Product Code: NHA ●

3. Predicate/Reference Devices:

Predicate Device Name	510(k)	Company Name
MIS C1 Conical Connection Dental Implant System
(Narrow Platform)	K172505	MIS (part of Dentsply Sirona)
Reference Device Name	510(k)	Company Name
MIS C1 Conical Connection Dental Implant System
(Standard and Wide Platform)	K112162	MIS (part of Dentsply Sirona)
MIS V3 Conical Connection Dental Implants System
(reference device)	K163349	MIS (part of Dentsply Sirona)
MIS CLEAR Dental Implant System	K200102	MIS (part of Dentsply Sirona)
PrimeTaper EV Dental Implants Ø3.0	K220841	Dentsply Sirona
SEVEN Implants, BIOCOM Implants, LANCE Implants	K103089	MIS (part of Dentsply Sirona)
MIS Internal Hex Dental Implant System (SEVEN
Implants)	K180282	MIS (part of Dentsply Sirona)
MIS Dental Implant System (Lance Implants)	K040807	MIS (part of Dentsply Sirona)
MIS Dental Implant System (Lance Implants)	K192149	MIS (part of Dentsply Sirona)

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4. Description of Device:

The proposed MIS LYNX Conical Connection Dental Implants are intended for one- or two-stage dental implant procedures and are used in the upper or lower jaw for supporting tooth replacement to restore chewing function.

The proposed dental implants have an internal conical connection with an anti-rotation index of six positions for standard and wide platforms and four positions for narrow platform.

The proposed implants and cover screw are manufactured from titanium alloy (Ti-6A1-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant).

The 3.3 mm diameter size implant is available in 10, 11.5, 13, and 16 mm lengths while the 3.75, 4.2, and 5.0 mm diameter size implants are available in 8, 10, 11.5, 13, and 16 mm lengths.

The proposed implants feature an outer profile which has a coronal half which is cylindrical and an apical half which is conical. The threads are designed so the implant has a self-drilling property. The geometric design also includes spiral channels (flutes) stemming from the apex. These spiral channels are designed to enable insertion torque reduction when applying reverse torque. The proposed implant design also includes circumferential grooves at the coronal area which are called "micro-rings". These horizontal micro-rings are designed to increase the BIC (Bone to Implant Contact) of the implant with the bone. The proposed implants also feature a triangular neck ("V-Cut''). The gaps around the sides of the implant neck are designed to result in an open, compression free zone.

The implant-abutment connection surface of the proposed MIS LYNX Conical Connection Implant is anodized for color coding to indicate the platform: yellow for narrow platform implants, purple for standard platform implants, and green for wide platform implants. The proposed implants are packaged in either a dry or wet package. Implants packaged in the wet packaging configuration are packaged in NaCl solution and are not anodized. The liquid environment is intended to maintain the super-hydrophilic (contact angle exhibited by water in contact with the surface is equal to zero degrees) property of the proposed dental implants until the implants are installed in the patients.

Cover screws are intended to be used in a two-stage surgical procedure as temporary components to the proposed endosseous implant to allow healing of the soft tissue. They are inserted into the implant and the gums are sutured over it. Their purpose is to let the osseointegration begin without any forces being applied to the implant. After a healing period, the cover screw is exposed and removed, and replaced by either a healing cap or an abutment. The cover screws are also anodized for color coding.

6

5. Intended Use and Indications for Use:

The proposed device and the predicate device, MIS C1 Conical Connection Dental Implant System (K172505), have the same intended use.

The Indications for Use of the proposed device are very similar to those of the predicate device. The only differences are that redundancy related to restoring patient chewing function was removed, and reference to a discontinued product was also removed. Otherwise, Indications for Use are the same.

Item of Comparison	Proposed device	Predicate device	Discussion
	MIS LYNX Conical Connection
Implant System (K241692)	MIC C1 Conical Connection
Dental Implant System (Narrow
Platform)
(K172505)
Intended Use	Intended to be surgically placed in
the bone of the upper or lower jaw
arches for anchoring or supporting
tooth replacement to restore
chewing function.	Intended to be surgically placed in
the bone of the upper or lower jaw
arches for anchoring or
supporting tooth replacement to
restore chewing function.	Same
Indications for Use	MIS Dental Implant System is
intended to be surgically placed in
the bone of the upper or lower jaw
arches to provide support for
prosthetic devices, such as artificial
teeth, in order to restore masticatory
function. When a one-stage surgical
procedure is applied, the implant
may be immediately loaded when
good primary stability is achieved
and the occlusal load is appropriate.
Narrow implants (Ø3.3mm) are
indicated for use in surgical and
restorative applications for
placement only in the mandibular
central, lateral incisor and maxillary
lateral incisor regions of partially
edentulous jaws, to provide support
for prosthetic devices such as
artificial teeth. Mandibular central
and lateral incisors must be splinted
if using two or more narrow
implants adjacent to one another.	MIS dental implant system is
intended to be surgically placed in
the bone of the upper or lower jaw
arches to provide support for
prosthetic devices, such as
artificial teeth, in order to restore
masticatory function.
When a one-stage surgical
procedure is applied, the implant
may be immediately loaded when
good primary stability is achieved
and the occlusal load is
appropriate.
Narrow implants (Ø3.3mm &
UNO) are indicated for use in
surgical and restorative
applications for placement only in
the mandibular central, lateral
incisor and maxillary lateral
incisor regions of partially
edentulous jaws, to provide
support for prosthetic devices
such as artificial teeth, in order to
restore the patient chewing
function. Mandibular central and
lateral incisors must be splinted if
using two or more narrow
implants adjacent to one another.	Very similar
Indications for Use.

The only differences
are that the predicate
device's indications
include the words
"& UNO" which is
an implant system
that is no longer
marketed by the
manufacturer. In
addition, "in order to
restore the patient
chewing function" is
removed from the
proposed device
indications as it is
redundant with "in
order to restore
masticatory
function". |

Table 5.1 Comparison of Intended Use and Indications for Use of Proposed and Predicate Device

7

6. Technological Comparison:

The proposed MIS LYNX Conical Connection Implants are bone level implants made of the same raw material (Ti-6Al-4V ELI per ASTM F136) that undergo the same manufacturing process as the predicate device (K172505).

The conical connection of the proposed implants has the same 12° cone angulation as the predicate device (K172505). The implant-abutment conical connection of the narrow platform implants is identical to that of the predicate device (K172505), the standard platform connection is identical to that of the reference device K163349 and the wide platform connection is similar to that of the reference device (K112162). The proposed implant diameters also correspond to the available diameters in the predicate (K172505) and reference (K112162) devices.

The overall tapered body design and apex, and profile of the circumferential grooves in the coronal area of the implant, called "Micro-Rings", of the proposed MIS LYNX Conical Connection implants are the same as those of the predicate device (K172505).

The proposed implants have gaps around the sides of the implant, creating a "V-Cut" triangular neck, similar to the reference device (K163349). The minor differences in the design of the outer thread of the proposed implants from the predicate device (K172505) do not raise new questions on safety and effectiveness as demonstrated with the results of fatigue testing.

The lengths of the narrow platform implants are identical to those of the predicate device (K172505). The lengths of the standard and wide platforms implants are identical to those of the reference device (K112162).

The predicate device (K172505) is available in two packaging configurations. A "Dry" packaging configuration in which the implant is placed in an inner tube in air, and a "Wet" packaging configuration in which the implant is placed in an inner tube in NaCl solution. The "Wet" packaging configuration of the predicate device (K172505) was cleared under K200102.

The proposed MIS LYNX Conical Connection implants and cover screws, in both "Dry" and "Wet" packaging configurations, are placed in the inner tube cleared under K200102 with the exception of an additional silicone O-ring that was added to the cap of the inner tube for the "Wet" packaging configuration. The secondary package of the proposed implants and cover screws is different from that of the predicate device (K172505, as modified in K200102): while the predicate device (K172505) inner tube is placed in an outer tube, that serves as the sterile barrier, the proposed implants inner tube is placed in a blister packaging was demonstrated to be substantially equivalent to the secondary package of the predicate device (K172505, as modified in K200102) via sterility and shelf-life testing.

Both the proposed device and the predicate device (K172505) are delivered sterile, for single use, sterilized by Gamma radiation.

An overall comparison of the technological characteristics of the proposed MIS LYNX Conical Connection Implants and cover screws to the predicate device (K172505, as modified in K200102) and reference devices (K112162, K163349, as modified in K200102) is provided in Table 6.1.

8

| Item | Proposed Device
MIS LYNX Conical
Connection Dental Implant
System
K241692 | Predicate Device
MIS C1 Conical Connection
Dental Implant System
K172505 with wet packaging
configuration cleared in
K200102 | Reference Device
MIS C1 Conical Connection
Dental Implant System
K112162 with wet packaging
configuration cleared in
K200102 | Reference Device
MIS V3 Conical Connection
Dental Implant System
K163349 with wet packaging
configuration cleared in
K200102 | Equivalence Comparison |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA | Same |
| Manufacturer | MIS Implants Technologies Ltd.
(part of Dentsply Sirona) | MIS Implants Technologies Ltd.
(part of Dentsply Sirona) | MIS Implants Technologies Ltd.
(part of Dentsply Sirona) | MIS Implants Technologies Ltd.
(part of Dentsply Sirona) | Same |
| Implant
Material | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | Same |
| Implant Surface
Treatment | For implants in "Dry"
packaging configuration:
Anodized (internally), sand
blasted and acid etched
For implants in "Wet"
packaging configuration:
Sand blasted and acid etched | For implants in "Dry"
packaging configuration:
Anodized (internally), sand
blasted and acid etched
For implants in "Wet"
packaging configuration:
Sand blasted and acid etched | For implants in "Dry"
packaging configuration:
Anodized (internally), sand
blasted and acid etched
For implants in "Wet"
packaging configuration:
Sand blasted and acid etched | For implants in "Dry"
packaging configuration:
Anodized (internally), sand
blasted and acid etched
For implants in "Wet"
packaging configuration:
Sand blasted and acid etched | Same |
| Implant
Connection
Type | For Narrow Platform:
Conical connection with four
index slots with even width
Cone angulation 12°
For Standard & Wide
Platforms:
Conical connection with six
index slots with alternating
width
Cone angulation 12° | For Narrow Platform:
Conical connection with four
index slots with even width
Cone angulation 12° | For Standard and Wide
Platforms:
Conical connection with six
index slots with even width
Cone angulation 12° | For Narrow Platform:
Conical connection with three
index slots with even width
Cone angulation 12°
For Standard Platforms:
Conical connection with six
index slots with alternating
width
Cone angulation 12° | Similar
The narrow platform
connection of the proposed
implants is identical to that of
the predicate device (K172505).
The standard platform
connection of the proposed
implants is identical to that of
the reference device standard
platform (K163349).
The wide platform connection
is similar to that of the
reference device (K112162).
The cone angulation of 12° is
the same for the proposed,
predicate and reference devices. |
| Implant Overall
Body Design | Tapered. The implant body is
half cylindrical (the coronal part
of the implant) and half conical
(the apical part of the implant).
The implant is threaded. | Tapered. The implant body is
half cylindrical (the coronal part
of the implant) and half conical
(the apical part of the implant).
The implant is threaded. | Tapered, SP - the implant body
is half cylindrical (the coronal
part of the implant) and half
conical (the apical part of the
implant). The implant is
threaded. | Tapered. The implant body with
the "V-Cut" is cylindrical (the
coronal part of the implant) and
the body of the implant is
conical (the apical part of the
implant). The implant is
threaded. | Same as predicate device
(K172505). |
| Item | Proposed Device
MIS LYNX Conical
Connection Dental Implant
System
K241692 | Predicate Device
MIS C1 Conical Connection
Dental Implant System
K172505 with wet packaging
configuration cleared in
K200102 | Reference Device
MIS C1 Conical Connection
Dental Implant System
K112162 with wet packaging
configuration cleared in
K200102 | Reference Device
MIS V3 Conical Connection
Dental Implant System
K163349 with wet packaging
configuration cleared in
K200102 | Equivalence Comparison |
| Implant Neck | "V-Cut" a back-tapered
triangular neck | Round neck | Round neck | "V-Cut" a triangular neck | Similar
The differences in the
angulation and radius with
reference device (K163349) do
not affect the proposed
implants' strength and stability
as demonstrated in fatigue
testing. |
| Implant Apex | Domed apex | Domed apex | Domed apex | Flat apex | Same
The proposed device has the
same apical design as the
predicate (K172505) and
reference (K112162) devices. |
| Implant Outer
Thread | Dual thread
The threads are thin at the apical
portion, and thicker at the
coronal portion of the implant's
body. | Dual thread
The threads are thin at the apical
portion, and thicker at the
coronal portion of the implant's
body | Dual thread
The threads are thin at the apical
portion, and thicker at the
coronal portion of the implant's
body | Dual thread
The threads are thin at the apical
portion, and thicker at the
coronal portion of the implant's
body | Similar
The minor differences in the
lead of the outer thread and the
pitch created by it, are due to
the slight changes in the design
of the body of the implant. The
minor differences in the outer
thread lead and pitch do not
affect the proposed implants'
strength and stability as
demonstrated in fatigue testing. |
| Type of
Implant | Bone level implant | Bone level implant | Bone level implant | Bone level implant | Same |
| Implant
Platform | Narrow Platform (NP),
Standard Platform (SP),
Wide Platform (WP) | Narrow Platform (NP) | Standard Platform (SP),
Wide Platform (WP) | Narrow Platform (NP),
Standard Platform (SP) | Same
No difference between the
platforms of the proposed
implants and the platforms
available with the predicate
(K172505) and reference
(K112162) devices, combined. |
| Item | Proposed Device
MIS LYNX Conical
Connection Dental Implant
System
K241692 | Predicate Device
MIS C1 Conical Connection
Dental Implant System
K172505 with wet packaging
configuration cleared in
K200102 | Reference Device
MIS C1 Conical Connection
Dental Implant System
K112162 with wet packaging
configuration cleared in
K200102 | Reference Device
MIS V3 Conical Connection
Dental Implant System
K163349 with wet packaging
configuration cleared in
K200102 | Equivalence Comparison |
| Diameters | SP: Ø 3.75 mm, 4.20 mm,
WP: Ø 5.00 mm | | WP: Ø 5.00 mm | SP: Ø 3.90 mm, 4.30 mm, 5.00
mm | No difference between the
diameters of the proposed
implants and the diameters
available with the predicate
(K172505) and reference
(K112162) devices, combined. |
| Implant
Lengths | For Ø 3.30 implants:
10, 11.5, 13, 16 mm
For Ø 3.75, Ø 4.20 & Ø 5.00
implants:
8, 10, 11.5, 13, 16 mm | For Ø 3.30 implants:
10, 11.5, 13, 16 mm | For Ø 3.75, Ø 4.20 & Ø 5.00
implants:
8, 10, 11.5, 13, 16 mm | For Ø 3.30 implants:
10, 11.5, 13, 16 mm
For Ø 3.90, Ø 4.30 & Ø 5.00
implants:
8, 10, 11.5, 13, 16 mm | Same
For Ø 3.30 implants: There is
no difference between the
lengths of the proposed
implants and the length of the
predicate device (K172505).
For Ø 3.75, Ø 4.20 & Ø 5.00
implants: There is no difference
between the lengths of the
proposed implants and the
length of the reference device
(K112162). |
| Cover Screw
Material | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | Same |
| Cover Screw
Surface
Treatment | Polished and anodized after
machined | Polished and anodized after
machined | Polished and anodized after
machined | Polished and anodized after
machined | Same |
| Cover Screw
Connection Type | For Narrow Platform,
Standard & Wide Platforms:
Conical connection.
Cone angulation 14° | For Narrow Platform:
Conical connection.
Cone angulation 12° | For Standard and Wide
Platforms:
Conical connection.
Cone angulation 12° | For Narrow & Standard
Platforms:
Conical connection.
Cone angulation 12° | Similar
The connection of the proposed
cover screws is similar in
design to the reference device
(K163349). . |
| Cover Screw
Diameters | NP: Ø 2.77 to 2.79 mm
SP: Ø 3.15 to 3.17 mm
WP: Ø 4.00 to 4.02 mm | NP: Ø 3.30 mm | SP: Ø 3.75 mm
WP: Ø 5.00 mm | NP: Ø 2.77 to 2.79 mm
SP: Ø 3.15 to 3.17 mm | Similar
There is no difference between
the diameters of the proposed
NP and SP cover screws
compared to those of the
reference device (K163349).
These diameters correspond to |
| Item | Proposed Device
MIS LYNX Conical
Connection Dental Implant
System
K241692 | Predicate Device
MIS C1 Conical Connection
Dental Implant System
K172505 with wet packaging
configuration cleared in
K200102 | Reference Device
MIS C1 Conical Connection
Dental Implant System
K112162 with wet packaging
configuration cleared in
K200102 | Reference Device
MIS V3 Conical Connection
Dental Implant System
K163349 with wet packaging
configuration cleared in
K200102 | Equivalence Comparison |
| | | | | | the diameters of the implants'
inner connection.
Similarly, the diameter of the
proposed WP cover screw
corresponds to the diameter of
the proposed device WP
implant inner connection. |
| Packaging of
Implant and
Cover Screw | Inner tube/Outer blister
packaging | Double tube packaging | Double tube packaging | Double tube packaging | Different. Performance and
safety of modified packaging
and materials were verified via
packaging validation, shelf-life
testing, sterility testing, and
bench testing. |
| Sterilization
Method of
Implant and
Cover Screw | Delivered sterile, for single use
Sterilization by Gamma
Radiation
SAL 10-6 | Delivered sterile, for single use
Sterilization by Gamma
Radiation
SAL 10-6 | Delivered sterile, for single use
Sterilization by Gamma
Radiation
SAL 10-6 | Delivered sterile, for single use
Sterilization by Gamma
Radiation
SAL 10-6 | Same |

Table 6.1 Comparison of Technological Characteristics between the Proposed Device and the Reference Devices (Implants)

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7. Non-Clinical Tests Summary and Conclusion:

Fatigue testing was performed according to ISO 14801:2016, Dentistry - Implants - Dynamic fatigue test for endosseous dental implants, and FDA guidance document "Root-form endosseous dental implants and endosseous dental abutments", and confirms that the proposed device is similar or exceeds performance when compared to the predicate device (K172505) and reference (K112162) devices.

Biocompatibility assessment was performed to evaluate the biocompatibility profile of the implants and screws packaged in modified inner tube packaging according to the following standards:

Cytotoxicity testing was performed according to ISO 10993-5:2009 Biological . evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
. Irritation testing was performed according to ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
. Sensitization testing was performed according to ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Material mediated pyrogenicity testing was assessed per recommendations of FDA's ● 2023 Biocompatibility Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process""
. Acute systemic toxicity was performed according to ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
. Genotoxicity was performed according to ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicitv
Analytical chemistry testing and chemical characterization was performed according to ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
Toxicological risk assessment was performed according to ISO/TS 21726:2019, Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents and ISO 10993-17: 2023 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents

Dose mapping was performed to ensure that each routine Gamma irradiation will result in a minimum of 20kGy. The dose mapping was performed according to:

ISO 11137-1:2006, Sterilization of health care products Radiation Part 1: ● Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-3:2017, Sterilization of health care products Radiation Part 3: . Guidance on dosimetric aspects of development, validation and routine control, and
ISO/ASTM 52303:2015 Guide for absorbed-dose mapping in radiation processing ● facilities.

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Bioburden testing was performed on the proposed final, finished packaging configuration according to:

AAMI TIR35:2016 Sterilization of Health Care Products Radiation Sterilization -● Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits, and
BS EN ISO 11137-2:2015- Sterilization of Health Care Products Radiation Part 2: ● Establishing the sterilization dose.

Based on the results, the proposed device was included into the existing sterilization.

Sterility testing was performed according to the following standard to ensure that the packaging maintains the sterility of the device after simulated distribution:

ISO 11737-2:2019(E) Sterilization of health care products Microbiological ● methods - Part 2: Tests of sterility performed in the definition, validation and maintenances of a sterilization process
To confirm the acceptability of the shelf-life, prior to accelerated aging, representative implants underwent simulated distribution and transportation testing according to:
ASTM D4169-22 Standard Practice for Performance Testing of Shipping ● Containers and Systems
. ASTM D4332-22 - Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing

After one year accelerated aging, visual inspection, packaging integrity testing, seal strength testing, "wet" packaging weight loss testing, and hydrophilicity testing were performed on representative implants and the subject device according to the following standards and methods:

. ASTM F1980-21 - Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
ASTM F1929-15 - Standard test method for detecting seal leaks in porous medical packaging by dye penetration
ASTM F2096-11: 2019 Standard Test for detecting gross leaks in packaging by ● internal pressurization (Bubble test)
ASTM F88/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier ● Materials
BS EN 868-5:2018 - Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods
Hydrophilicity testing according to internal test method .

Test results met acceptance criteria.

The following testing or analysis was performed on the worst-case implant combination for Dentsply Sirona implant products, which consider the proposed implants:

. Magnetically induced displacement force, according to ASTM F2052-21. Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment
Magnetically induced torque, according to ASTM F2213-17, Standard test method ●

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for measurement of magnetically induced torque on medical devices in magnetic resonance environment

Image Artifact, according to ASTM F2119-07 (2013), Standard test method for ● evaluation of MR image artifacts from passive implants
RF Induced Heating Simulation using Computational modeling and simulation . (CM&S)

Based on the test or analysis results, device labeling for the proposed implants will indicate MRI Conditional.

1. Clinical Tests Summary and Conclusion:
  Not applicable. There are no clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.
1. Conclusion Regarding Substantial Equivalence:
  The proposed implants and abutments (cover screws) are made of the same material as the predicate device (K172505) and reference devices (K112162, K163349), which is Ti 6Al-4V ELI. The proposed implants undergo the same manufacturing process and surface treatment, and are provided sterilized by gamma irradiation. In addition, the proposed devices connect directly to the implant in the same conical connection, and share similarities in design characteristics. Differences in implant design were confirmed via fatigue testing where the proposed device was shown to perform as well or better than the predicate (K172505) and reference (K112162) devices.

Changes in packaging materials, components, and configuration mainly by adding an additional component to the inner packaging and changes to the secondary packaging from an outer tube to a blister package, were assessed via sterilization, packaging integrity, and shelf-life testing to confirm that the changes do not raise new questions regarding safety and effectiveness of the final finished device. In addition, biocompatibility testing was performed to confirm the biological safety of the proposed implants.

The differences in design and packaging between the proposed device, the predicate device, and reference devices do not raise new concerns regarding safety or performance. The performance and safety data included in this premarket notification support a conclusion of substantial equivalence.