(84 days)
No
The summary describes a dental implant system and its mechanical, biocompatibility, sterilization, and shelf-life testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes.
The device is intended to restore masticatory function, which is a therapeutic outcome.
No
The device is an implant system designed to support prosthetic devices to restore masticatory function, not to diagnose a condition.
No
The device description clearly states it is a physical dental implant and associated hardware (abutments), not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant system intended to be surgically placed in bone to support prosthetic devices and restore masticatory function. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the physical characteristics of the implant and its components (abutments), all of which are physical devices for surgical implantation and support of prosthetics.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the MIS Dental Implant System described is a medical device, specifically a surgical implant, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MIS Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic device, 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 stability is achieved and the occlusal load in appropriate.
Narrow implants (03.3mm) 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 (comma separated list FDA assigned to the subject device)
DZE
Device Description
The proposed MIS Lance+ Conical Connection Implant are dental implants with a cvlindrical and conical shaped outer profile. The implants have an internal conical implant-abutment connection geometry with an anti-rotation index of six positions for standard and wide platforms and four positions for narrow platform. The conical implant-abutment connection is identical to the internal conical connection geometry incorporated in the design of the reference device MIS C1 Conical Connection Implants (K172505). The implant abutment connection surface of the MIS Lance+ Conical Connection Implant is anodized for coloring coding purposes to indicate the platform. The color coding is identical to the reference devices MIS C1 Conical Connection Implant System (K172505).
The MIS Lance+ Conical Connection Implants are intended to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments and screwretained abutments, which were previously cleared for use with the MIS C1 Conical Connection Dental Implant System (K172505 for NP abutments and K112162 for SP and WP abutments). These abutments are manufactured with a conical connection compatible with the implants interface. Dental implant abutments are intended to be used in the upper or lower jaw used for supporting tooth replacements to restore chewing function. The abutments in combination with two-stage endosseous implants are intended to be used as a foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to fixed partial dentures using cementretained supra-constructions. No new Abutments are being proposed as part of this submission.
In addition, the proposed MIS Lance+ Conical Connection Implants will be provided in a wet package configuration immersed in NaCl solution as cleared under K200102 and branded as "CLEAR". The MIS CLEAR Lance+ Conical Connection Implants which are intended to be packaged in NaCl solution are not anodized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper and lower jaw arches
mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws
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 - Comparative mechanical testing of the proposed MIS Lance+ Conical Connection Implants and MIS C1 Conical Connection Implants in accordance to ISO 14801:2016 was conducted and demonstrated the subject implants do not create a new worstcase as compared to this predicate device with identical connection platform. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicate and reference device.
- Biocompatibility Testing- The proposed MIS Lance+ Conical Connection Implants are made from the same material, and undergo the same surface treatments: acid-etching, sand blasting and anodizing. They are manufactured under the same processing conditions and at the same manufacturing location as the predicate device, MIS Lance+ Internal Hex Dental Implant (K192149) and for the MIS CLEAR Implants (K200102). Therefore, no further biocompatibility testing was conducted in support of substantial equivalence.
- Sterilization Testing -Sterilization validation tests were conducted on each group of packaging type (dry and wet) products in compliance with both ANSVAAMI/ISO 11137-1 and ANSI/AAMI/ISO 11137-2. Test results have demonstrated that the SAL of 106 was achieved and all testing requirements weremet.
- Shelf Life Testing – for the products which are supplied sterile, shelf life studies were completed by an independent testing laboratory. In in order to validate the integrity of the final package, the studies were conducted in accordance with ISO 11607-1. Dry packaged implants utilized real-time aging for 5 years per ISO 11607-1:2019 and ASTM F1929-15. Wet packaged implants utilized accelerated aging simulating two years per ASTM F1980 to demonstrate a two-year shelf-life for both package integrity (sterile barrier). Device performance (hydrophilicity) Device performance (hydrophilicity) was demonstrated with accelerated aging testing similar to the reference device K200102.
- For products supplied sterile, a LAL test is conducted periodically to verify the endotoxin limit is within acceptance criteria according to USP 85, USP 161 and ANSI/AAMI/ST72.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Dentsply Sirona Rebecca Sporer Regulatory Affairs Specialist 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401
Re: K210886
Trade/Device Name: MIS Lance+ Conical Connection Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: March 24, 2021 Received: March 25, 2021
Dear Rebecca Sporer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210886
Device Name
MIS Lance+ Conical Connection Dental Implant System
Indications for Use (Describe)
MIS Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic device, 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 stability is achieved and the occlusal load in appropriate.
Narrow implants (03.3mm) 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) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text and the leaf are in a gray color.
510(k) SUMMARY K210886
1.0 Submitter Information:
Dentsply Sirona Inc. 221 West Philadelphia Street Suite 60W York, PA 17401
| Contact Person: | Rebecca Sporer |
|---|---|
| Title: | Regulatory Affairs Specialist |
| Telephone Number: | 717-849-4793 |
| Fax Number: | 717-849-4343 |
| Date Prepared: | 17 June 2021 |
2.0 Device Name
- Proprietary Name: MIS Lance+ Conical Connection Dental Implant System
- Endosseous dental implant Classification Name: ●
- . CFR Number: 872.3640
- . Device Class: Class II
- Product Code: DZE
3.0 Predicate Device
The predicate and reference device that have been identified relating to the substantial equivalence of the proposed MIS Lance+ Conical Connection Implants entailing a modification of the MIS Lance+ Internal Hex Dental Implant System (K192149) with the conical connection of the MIS C1 Conical Connection Dental Implant System (K172505 for C1 Narrow platform implants and K112162 for C1 standard and wide platform implants). The proposed MIS Lance+ Conical Connection Implants will be offered as well in a wet packaging like the MIS implants cleared under MIS CLEAR Dental Implant System (K200102).
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| MIS Dental Implant System | ||
| (MIS Lance+ Internal Hex Dental Implant System) | K192149 | MIS Implants Technologies Ltd. |
| (Dentsply Sirona) | ||
| Reference Device Name | 510(k) | Company Name |
| MIS C1 Narrow Platform Conical Connection | ||
| Dental Implant System | ||
| (MIS C1 Conical Connection Dental Implant | ||
| System) | K172505 | MIS Implants Technologies Ltd. |
| (Dentsply Sirona) | ||
| MIS C1 Conical Connection Dental Implant | ||
| System – Standard and wide platforms | K112162 | MIS Implants Technologies Ltd. |
| (Dentsply Sirona) | ||
| MIS CLEAR Dental Implant System | K200102 | MIS Implants Technologies Ltd. |
| (Dentsply Sirona) |
4
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/4/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape in gray on the left, followed by the words "Dentsply" and "Sirona" stacked on top of each other in gray. The font is sans-serif and modern, and the overall design is clean and professional.
4.0 Device Description
The proposed MIS Lance+ Conical Connection Implant are dental implants with a cvlindrical and conical shaped outer profile. The implants have an internal conical implant-abutment connection geometry with an anti-rotation index of six positions for standard and wide platforms and four positions for narrow platform. The conical implant-abutment connection is identical to the internal conical connection geometry incorporated in the design of the reference device MIS C1 Conical Connection Implants (K172505). The implant abutment connection surface of the MIS Lance+ Conical Connection Implant is anodized for coloring coding purposes to indicate the platform. The color coding is identical to the reference devices MIS C1 Conical Connection Implant System (K172505).
The MIS Lance+ Conical Connection Implants are intended to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments and screwretained abutments, which were previously cleared for use with the MIS C1 Conical Connection Dental Implant System (K172505 for NP abutments and K112162 for SP and WP abutments). These abutments are manufactured with a conical connection compatible with the implants interface. Dental implant abutments are intended to be used in the upper or lower jaw used for supporting tooth replacements to restore chewing function. The abutments in combination with two-stage endosseous implants are intended to be used as a foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to fixed partial dentures using cementretained supra-constructions. No new Abutments are being proposed as part of this submission.
In addition, the proposed MIS Lance+ Conical Connection Implants will be provided in a wet package configuration immersed in NaCl solution as cleared under K200102 and branded as "CLEAR". The MIS CLEAR Lance+ Conical Connection Implants which are intended to be packaged in NaCl solution are not anodized.
5.0 Indication for Use
MIS Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic device, 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 in appropriate.
Narrow implants (03.3mm) 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.
6.0 Substantial Equivalence Discussion
For the purposes of substantial equivalence, the proposed MIS Lance+ Conical Connection Implants are compared to the predicate device MIS Lance + Internal Hex Implant System (K192149) with the reference device MIS C1 Conical Connection Dental Implant System (K172505) included in support of substantial equivalence. The proposed MIS Lance+ Conical Connection Implant System does not include short implants; this is noted in the difference in indications for use as seen in Table 6.1. The comparison table below (Tables 6.1 and 6.2) summarizes the proposed implants to the predicate devices with respect to indications for use, technological characteristics, materials and performance testing to demonstrate that the data provided for the proposed implants supports equivalence to the predicate device.
5
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/5/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized, abstract shape on the left, resembling a curved leaf or wave. To the right of the shape are the words "Dentsply" stacked on top of "Sirona", both in a sans-serif font. The logo is presented in a grayscale color scheme.
| Table 6.1 - Indication for Use Comparison | ||
|---|---|---|
| Subject Device | ||
| MIS Lance+ Conical Connection Implant System | ||
| Predicate Device | ||
| MIS Lance+ Internal Hex Dental Implant System | ||
| (K192149) | ||
| Indication for Use | MIS Dental Implant System is intended to be surgically placed in the bone | |
| of the upper and lower jaw arches to provide support for prosthetic device, | ||
| 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 in | ||
| 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 and lower jaw arches to provide support for prosthetic
device, 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 in 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 short implants are to be used only with straight abutments. |
6
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/6/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the words "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is a dark gray color. The logo is clean and modern, suggesting a company that is both innovative and reliable.
| Table 6.2 – Technological Characteristics comparison between the subject, predicate and reference Implant devices | ||||
|---|---|---|---|---|
| Trade | ||||
| Name | Proposed Device | |||
| MIS Dental Implant System | Predicate Device | |||
| MIS Dental Implants | ||||
| System (Lance +) | ||||
| (K192149) | Reference Device | |||
| MIS C1 Conical Connection | ||||
| Dental Implant System | ||||
| (K172505) | Equivalence Comparison | |||
| Material | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM | ||
| F136 | Ti-6Al-4V ELI per ASTM F136 | No difference. | ||
| Surface | ||||
| Treatment | For dry packaged Implants: | |||
| Anodized, sand blasted and acid | ||||
| etched | ||||
| For wet packaged Implants: | ||||
| Sand blasted and acid etched | Sand blasted and acid etched | Anodized, sand blasted and acid | ||
| etched | ||||
| For wet packaged Implants: | ||||
| Sand blasted and acid etched | The proposed Implants which will be packed in NaCL solution will | |||
| have the same surface treatment as the predicate device. The | ||||
| implants packed in Air ("dry") has the same surface treatment as the | ||||
| predicate device but the internal part of the implant will be anodized | ||||
| like the reference device. | ||||
| Connection | ||||
| Type | Conical with Index | |||
| Cone angulation 12° | Internal hexagon | Conical with Index | ||
| Cone angulation 12° | The aim of the modification of the Lance+ Implant to a conical | |||
| connection is based on the connection type of the C1 Implant. | ||||
| Body | ||||
| Design | Tapered, conical shape, threaded | Tapered, conical shape, | ||
| threaded | Tapered, threaded | No difference. Only change on Implant Abutment connection from | ||
| internal hexagon to conical with index. | ||||
| Apex | Domed apex | Domed apex | Domed apex | No difference |
| Thread | Triple | Triple | Dual | No difference. Only change on Implant Abutment connection from |
| internal hexagon to conical connection with index. | ||||
| Type of | ||||
| Implant | Bone level implant | Bone level implant | Bone level implant | No difference |
| Implant | ||||
| Platform | Standard Platform (SP), Wide | |||
| Platform | ||||
| (WP), Narrow Platform (NP) | SP, WP, NP | SP, WP, NP | No difference | |
| Implant | ||||
| Diameters | SP: Ø 3.75 mm, 4.20 mm, | |||
| WP: Ø 5.00 mm | ||||
| NP: Ø 3.30 mm | SP: Ø 3.75 mm, 4.20 mm, | |||
| WP: Ø 5.00 mm, 6.00 mm | ||||
| NP: Ø 3.30 mm | SP: Ø 3.75 mm, 4.20 mm, | |||
| WP: Ø 5.00 mm. | ||||
| NP: Ø 3.30 mm | The new proposed implants will not like the predicate device the | |||
| Implant Diameter of 6.00 mm since the prosthetic from C1 which is | ||||
| intended to be used do not support that size. | ||||
| Implant | ||||
| Lengths | SP, WP: 8, 10, 11.5, 13, 16 mm | |||
| NP: 10, 11.5, 13, 16 mm | 8, 10, 11.5, 13, 16 mm | 8, 10, 11.5, 13, 16 mm | No difference |
7
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/7/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized, abstract shape on the left, resembling a leaf or a curved shape in gray. To the right of the shape are the words "Dentsply" stacked on top of "Sirona", both in a sans-serif font and in gray color. The overall design is clean and modern.
| Table 6.2 - Technological Characteristics comparison between the subject, predicate and reference Implant devices | ||||
|---|---|---|---|---|
| Trade | ||||
| Name | Proposed Device | |||
| MIS Dental Implant System | Predicate Device | |||
| MIS Dental Implants | ||||
| System (Lance +) | ||||
| (K192149) | Reference Device | |||
| MIS C1 Conical Connection | ||||
| Dental Implant System | ||||
| (K172505) | Equivalence Comparison | |||
| Inner | ||||
| Package | ||||
| Medium | Air or NaCL solution | Air or NaCL solution | Air or NaCL solution | No difference. The wet packaging branded as CLEAR is cleared |
| under K200102 | ||||
| Sterilization | ||||
| Method | Radiation | Radiation | Radiation | No difference |
| Shelf Life | For dry packaged Implants: 5 | |||
| years | ||||
| For wet packaged CLEAR | ||||
| Implants (K200102): | ||||
| 2 years | For dry packaged Implants: | |||
| 5 years | ||||
| For wet packaged CLEAR | ||||
| Implants (K200102): | ||||
| 1 year | Dry packaged Implants: 5 years | The extended shelf-life for the CLEAR packaging was validated with | ||
| performance testing. |
8
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/8/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized, abstract shape on the left, resembling a leaf or a curved form in gray. To the right of the shape are the words "Dentsply" on the top line and "Sirona" on the bottom line, both in a sans-serif font and also in gray.
7.0 Non-Clinical Performance Data
As part of demonstrating the substantial equivalence of the proposed MIS Lance+ Conical Connection Implant System to the predicate and reference devices, MIS Implants Technologies completed a number of non-clinical performance tests:
- -Fatigue Testing - Comparative mechanical testing of the proposed MIS Lance+ Conical Connection Implants and MIS C1 Conical Connection Implants in accordance to ISO 14801:2016 was conducted and demonstrated the subject implants do not create a new worstcase as compared to this predicate device with identical connection platform. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicate and reference device.
- -Biocompatibility Testing- The proposed MIS Lance+ Conical Connection Implants are made from the same material, and undergo the same surface treatments: acid-etching, sand blasting and anodizing. They are manufactured under the same processing conditions and at the same manufacturing location as the predicate device, MIS Lance+ Internal Hex Dental Implant (K192149) and for the MIS CLEAR Implants (K200102). Therefore, no further biocompatibility testing was conducted in support of substantial equivalence.
- -Sterilization Testing -Sterilization validation tests were conducted on each group of packaging type (dry and wet) products in compliance with both ANSVAAMI/ISO 11137-1 and ANSI/AAMI/ISO 11137-2. Test results have demonstrated that the SAL of 106 was achieved and all testing requirements weremet.
- -Shelf Life Testing – for the products which are supplied sterile, shelf life studies were completed by an independent testing laboratory. In in order to validate the integrity of the final package, the studies were conducted in accordance with ISO 11607-1. Dry packaged implants utilized real-time aging for 5 years per ISO 11607-1:2019 and ASTM F1929-15. Wet packaged implants utilized accelerated aging simulating two years per ASTM F1980 to demonstrate a two-year shelf-life for both package integrity (sterile barrier). Device performance (hydrophilicity) Device performance (hydrophilicity) was demonstrated with accelerated aging testing similar to the reference device K200102.
- -For products supplied sterile, a LAL test is conducted periodically to verify the endotoxin limit is within acceptance criteria according to USP 85, USP 161 and ANSI/AAMI/ST72.
8.0 Clinical Performance Data
No human clinical data were included to support substantial equivalence.
9.0 Conclusion Regarding Substantial Equivalence
The proposed MIS Lance+ conical connection implants have the same intended use, incorporate the same fundamental technology, and have the same indications for use as the predicate and reference devices. The results of the testing support a determination of substantial equivalence.