(166 days)
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.
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.
The provided document is a 510(k) Summary for the MIS LYNX Conical Connection Implant System. It details the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence through non-clinical testing.
However, the document does not describe a study that proves the device meets specific acceptance criteria based on clinical performance or an AI/algorithm-driven component. Instead, it focuses on non-clinical testing (fatigue, biocompatibility, sterilization, shelf-life, and MRI compatibility) to demonstrate the safety and effectiveness of the dental implant system itself, relative to predicate devices. There is no mention of an AI component, human-in-the-loop study, or any performance metrics like accuracy, sensitivity, or specificity that would be typical for an AI-driven medical device.
The section titled "8. Clinical Tests Summary and Conclusion" explicitly states: "Not applicable. There are no clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence."
Therefore, based solely on the provided text, I cannot generate a response that fulfills the request for acceptance criteria and study details related to an AI/algorithm's performance because such information is not present in the document. The device in question is a dental implant system, not a software device that would typically have acceptance criteria focused on AI performance metrics.
To directly answer your prompt, given the provided text:
1. A table of acceptance criteria and the reported device performance:
Not applicable. The document describes non-clinical testing for a dental implant system, not performance metrics for an AI/algorithm. The "acceptance criteria" for the non-clinical tests are implied as meeting the standards (e.g., ISO 14801:2016 for fatigue, ISO 10993 series for biocompatibility) and demonstrating equivalence or superiority to predicate devices. For example, "Fatigue testing... confirms that the proposed device is similar or exceeds performance when compared to the predicate device (K172505) and reference (K112162) devices." And "Test results met acceptance criteria" for shelf-life testing. However, specific numerical acceptance criteria and reported performance values for each of these tests are not provided in a table format within this summary.
2. Sample sized used for the test set and the data provenance:
Not applicable for an AI test set. The document refers to samples used for non-clinical tests (e.g., implants for fatigue testing, materials for biocompatibility). Specific sample sizes are not detailed, but the tests are conducted on representative devices. Data provenance is implied as being from the manufacturer's internal testing as part of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI/imaging device requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not have an algorithm providing standalone performance.
7. The type of ground truth used:
Not applicable.
8. The sample size for the training set:
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable.
{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)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
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 |
-
- Device Name:
●
- 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 (SEVENImplants) | 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) |
{5}------------------------------------------------
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 ConnectionImplant System (K241692) | MIC C1 Conical ConnectionDental Implant System (NarrowPlatform)(K172505) | ||
| Intended Use | Intended to be surgically placed inthe bone of the upper or lower jawarches for anchoring or supportingtooth replacement to restorechewing function. | Intended to be surgically placed inthe bone of the upper or lower jawarches for anchoring orsupporting tooth replacement torestore chewing function. | Same |
| Indications for Use | MIS Dental Implant System isintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such as artificialteeth, in order to restore masticatoryfunction. When a one-stage surgicalprocedure is applied, the implantmay be immediately loaded whengood primary stability is achievedand the occlusal load is appropriate.Narrow implants (Ø3.3mm) areindicated for use in surgical andrestorative applications forplacement only in the mandibularcentral, lateral incisor and maxillarylateral incisor regions of partiallyedentulous jaws, to provide supportfor prosthetic devices such asartificial teeth. Mandibular centraland lateral incisors must be splintedif using two or more narrowimplants adjacent to one another. | MIS dental implant system isintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such asartificial teeth, in order to restoremasticatory function.When a one-stage surgicalprocedure is applied, the implantmay be immediately loaded whengood primary stability is achievedand the occlusal load isappropriate.Narrow implants (Ø3.3mm &UNO) are indicated for use insurgical and restorativeapplications for placement only inthe mandibular central, lateralincisor and maxillary lateralincisor regions of partiallyedentulous jaws, to providesupport for prosthetic devicessuch as artificial teeth, in order torestore the patient chewingfunction. Mandibular central andlateral incisors must be splinted ifusing two or more narrowimplants adjacent to one another. | Very similarIndications for Use.The only differencesare that the predicatedevice's indicationsinclude the words"& UNO" which isan implant systemthat is no longermarketed by themanufacturer. Inaddition, "in order torestore the patientchewing function" isremoved from theproposed deviceindications as it isredundant with "inorder to restoremasticatoryfunction". |
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 DeviceMIS LYNX ConicalConnection Dental ImplantSystemK241692 | Predicate DeviceMIS C1 Conical ConnectionDental Implant SystemK172505 with wet packagingconfiguration cleared inK200102 | Reference DeviceMIS C1 Conical ConnectionDental Implant SystemK112162 with wet packagingconfiguration cleared inK200102 | Reference DeviceMIS V3 Conical ConnectionDental Implant SystemK163349 with wet packagingconfiguration cleared inK200102 | 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 |
| ImplantMaterial | 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 SurfaceTreatment | For implants in "Dry"packaging configuration:Anodized (internally), sandblasted and acid etchedFor implants in "Wet"packaging configuration:Sand blasted and acid etched | For implants in "Dry"packaging configuration:Anodized (internally), sandblasted and acid etchedFor implants in "Wet"packaging configuration:Sand blasted and acid etched | For implants in "Dry"packaging configuration:Anodized (internally), sandblasted and acid etchedFor implants in "Wet"packaging configuration:Sand blasted and acid etched | For implants in "Dry"packaging configuration:Anodized (internally), sandblasted and acid etchedFor implants in "Wet"packaging configuration:Sand blasted and acid etched | Same |
| ImplantConnectionType | For Narrow Platform:Conical connection with fourindex slots with even widthCone angulation 12°For Standard & WidePlatforms:Conical connection with sixindex slots with alternatingwidthCone angulation 12° | For Narrow Platform:Conical connection with fourindex slots with even widthCone angulation 12° | For Standard and WidePlatforms:Conical connection with sixindex slots with even widthCone angulation 12° | For Narrow Platform:Conical connection with threeindex slots with even widthCone angulation 12°For Standard Platforms:Conical connection with sixindex slots with alternatingwidthCone angulation 12° | SimilarThe narrow platformconnection of the proposedimplants is identical to that ofthe predicate device (K172505).The standard platformconnection of the proposedimplants is identical to that ofthe reference device standardplatform (K163349).The wide platform connectionis similar to that of thereference device (K112162).The cone angulation of 12° isthe same for the proposed,predicate and reference devices. |
| Implant OverallBody Design | Tapered. The implant body ishalf cylindrical (the coronal partof the implant) and half conical(the apical part of the implant).The implant is threaded. | Tapered. The implant body ishalf cylindrical (the coronal partof the implant) and half conical(the apical part of the implant).The implant is threaded. | Tapered, SP - the implant bodyis half cylindrical (the coronalpart of the implant) and halfconical (the apical part of theimplant). The implant isthreaded. | Tapered. The implant body withthe "V-Cut" is cylindrical (thecoronal part of the implant) andthe body of the implant isconical (the apical part of theimplant). The implant isthreaded. | Same as predicate device(K172505). |
| Item | Proposed DeviceMIS LYNX ConicalConnection Dental ImplantSystemK241692 | Predicate DeviceMIS C1 Conical ConnectionDental Implant SystemK172505 with wet packagingconfiguration cleared inK200102 | Reference DeviceMIS C1 Conical ConnectionDental Implant SystemK112162 with wet packagingconfiguration cleared inK200102 | Reference DeviceMIS V3 Conical ConnectionDental Implant SystemK163349 with wet packagingconfiguration cleared inK200102 | Equivalence Comparison |
| Implant Neck | "V-Cut" a back-taperedtriangular neck | Round neck | Round neck | "V-Cut" a triangular neck | SimilarThe differences in theangulation and radius withreference device (K163349) donot affect the proposedimplants' strength and stabilityas demonstrated in fatiguetesting. |
| Implant Apex | Domed apex | Domed apex | Domed apex | Flat apex | SameThe proposed device has thesame apical design as thepredicate (K172505) andreference (K112162) devices. |
| Implant OuterThread | Dual threadThe threads are thin at the apicalportion, and thicker at thecoronal portion of the implant'sbody. | Dual threadThe threads are thin at the apicalportion, and thicker at thecoronal portion of the implant'sbody | Dual threadThe threads are thin at the apicalportion, and thicker at thecoronal portion of the implant'sbody | Dual threadThe threads are thin at the apicalportion, and thicker at thecoronal portion of the implant'sbody | SimilarThe minor differences in thelead of the outer thread and thepitch created by it, are due tothe slight changes in the designof the body of the implant. Theminor differences in the outerthread lead and pitch do notaffect the proposed implants'strength and stability asdemonstrated in fatigue testing. |
| Type ofImplant | Bone level implant | Bone level implant | Bone level implant | Bone level implant | Same |
| ImplantPlatform | Narrow Platform (NP),Standard Platform (SP),Wide Platform (WP) | Narrow Platform (NP) | Standard Platform (SP),Wide Platform (WP) | Narrow Platform (NP),Standard Platform (SP) | SameNo difference between theplatforms of the proposedimplants and the platformsavailable with the predicate(K172505) and reference(K112162) devices, combined. |
| Item | Proposed DeviceMIS LYNX ConicalConnection Dental ImplantSystemK241692 | Predicate DeviceMIS C1 Conical ConnectionDental Implant SystemK172505 with wet packagingconfiguration cleared inK200102 | Reference DeviceMIS C1 Conical ConnectionDental Implant SystemK112162 with wet packagingconfiguration cleared inK200102 | Reference DeviceMIS V3 Conical ConnectionDental Implant SystemK163349 with wet packagingconfiguration cleared inK200102 | 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, 5.00mm | No difference between thediameters of the proposedimplants and the diametersavailable with the predicate(K172505) and reference(K112162) devices, combined. | |
| ImplantLengths | For Ø 3.30 implants:10, 11.5, 13, 16 mmFor Ø 3.75, Ø 4.20 & Ø 5.00implants: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 5.00implants:8, 10, 11.5, 13, 16 mm | For Ø 3.30 implants:10, 11.5, 13, 16 mmFor Ø 3.90, Ø 4.30 & Ø 5.00implants:8, 10, 11.5, 13, 16 mm | SameFor Ø 3.30 implants: There isno difference between thelengths of the proposedimplants and the length of thepredicate device (K172505).For Ø 3.75, Ø 4.20 & Ø 5.00implants: There is no differencebetween the lengths of theproposed implants and thelength of the reference device(K112162). |
| Cover ScrewMaterial | 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 ScrewSurfaceTreatment | Polished and anodized aftermachined | Polished and anodized aftermachined | Polished and anodized aftermachined | Polished and anodized aftermachined | Same |
| Cover ScrewConnection Type | For Narrow Platform,Standard & Wide Platforms:Conical connection.Cone angulation 14° | For Narrow Platform:Conical connection.Cone angulation 12° | For Standard and WidePlatforms:Conical connection.Cone angulation 12° | For Narrow & StandardPlatforms:Conical connection.Cone angulation 12° | SimilarThe connection of the proposedcover screws is similar indesign to the reference device(K163349). . |
| Cover ScrewDiameters | NP: Ø 2.77 to 2.79 mmSP: Ø 3.15 to 3.17 mmWP: Ø 4.00 to 4.02 mm | NP: Ø 3.30 mm | SP: Ø 3.75 mmWP: Ø 5.00 mm | NP: Ø 2.77 to 2.79 mmSP: Ø 3.15 to 3.17 mm | SimilarThere is no difference betweenthe diameters of the proposedNP and SP cover screwscompared to those of thereference device (K163349).These diameters correspond to |
| Item | Proposed DeviceMIS LYNX ConicalConnection Dental ImplantSystemK241692 | Predicate DeviceMIS C1 Conical ConnectionDental Implant SystemK172505 with wet packagingconfiguration cleared inK200102 | Reference DeviceMIS C1 Conical ConnectionDental Implant SystemK112162 with wet packagingconfiguration cleared inK200102 | Reference DeviceMIS V3 Conical ConnectionDental Implant SystemK163349 with wet packagingconfiguration cleared inK200102 | Equivalence Comparison |
| the diameters of the implants'inner connection.Similarly, the diameter of theproposed WP cover screwcorresponds to the diameter ofthe proposed device WPimplant inner connection. | |||||
| Packaging ofImplant andCover Screw | Inner tube/Outer blisterpackaging | Double tube packaging | Double tube packaging | Double tube packaging | Different. Performance andsafety of modified packagingand materials were verified viapackaging validation, shelf-lifetesting, sterility testing, andbench testing. |
| SterilizationMethod ofImplant andCover Screw | Delivered sterile, for single useSterilization by GammaRadiationSAL 10-6 | Delivered sterile, for single useSterilization by GammaRadiationSAL 10-6 | Delivered sterile, for single useSterilization by GammaRadiationSAL 10-6 | Delivered sterile, for single useSterilization by GammaRadiationSAL 10-6 | Same |
Table 6.1 Comparison of Technological Characteristics between the Proposed Device and the Reference Devices (Implants)
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
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.
{13}------------------------------------------------
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 ●
{14}------------------------------------------------
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.
-
- 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.
- Clinical Tests Summary and Conclusion:
-
- 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.
- Conclusion Regarding Substantial Equivalence:
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.
§ 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.