(124 days)
No
The summary describes a dental implant system and its components, focusing on materials, mechanical properties, and biocompatibility. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device, a dental implant system, is used to surgically replace missing teeth and restore masticatory function, directly addressing a health-related condition.
No
Explanation: The document describes dental implants and abutments used to support prosthetic devices and restore masticatory function. It does not mention any diagnostic capabilities for identifying or assessing medical conditions.
No
The device description clearly states that the device is a "Dental Implant System" consisting of "Lance+ Dental Implants" and "MIS Internal Hex Cobalt Chrome (CoCr) abutments," which are physical components made of titanium alloy and CoCr alloy. There is no mention of software as the primary or sole component of the device.
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 surgically placed in the bone to support prosthetic devices. This is a surgical and restorative function within the body.
- Device Description: The description details the materials and components of dental implants and abutments, which are physical devices used in surgery and 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
MIS Dental Implant Systems are 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 short implants are to be used only with straight abutments.
MIS Dental Implant Systems are 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 (Ø3.3 mm) 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The proposed MIS Lance+ Internal Hex implants are a modification and line extension to the originally cleared Lance implants (K040807). The proposed Lance+ implants are manufactured from titanium alloy, Ti- 6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant compared to the prior CP titanium grade 4. Apart from the change in material, additional sizes are being added as a line extension.
The proposed MIS Internal Hex CoCr abutments are pre-manufactured prosthetic components directly connected to the endosseous dental implant and intended for use as an aid in prosthetic rehabilitation. They are intended for permanent restoration for single tooth or multiple units screw retained restorations. The lower part of the abutment, which connects directly to the implant, is made of CoCr alloy, and the upper part is made of plastic (POM). The plastic part is dissolved during the casting process. The abutment is connected to the implant by a prosthetic screw, supplied with the abutment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or 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)
Non-Clinical Performance Data:
- Fatigue Testing: Mechanical testing of the proposed MIS Lance+ Internal Hex implants in accordance to ISO 14801:2016 was conducted. 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.
- CoCr corrosion testing: All tested dental metal alloys have very low corrosion rates, with the lowest corrosion rate achieved for the CoCr-titanium couple, indicating that in physiological conditions the CoCr presents low risk of galvanic corrosion when coupled with titanium. The test establishes the proposed MIS Internal Hex CoCr abutments as having no risk for corrosion.
- Biocompatibility Testing: The proposed MIS Lance+ Internal Hex Implants are made from the same materials, under the same processing conditions and at the same manufacturing location as the predicate device, MIS Internal Hex Dental Implants (K180282). Therefore, no further biocompatibility testing was conducted in support of substantial equivalence. Biocompatibility testing (cytotoxicity) was conducted on the proposed MIS Internal Hex CoCr Abutments and results supported a conclusion non-cytotoxicity.
- Surface treatment of the proposed implants is identical to the surface treatment of the predicate device implants cleared under K180282 and the reference device implants cleared under K040807. Characterization of the surface treatment is provided with reference to the May, 2004, Guidance for Industry an FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
- Packaging configuration of the proposed dental implants, which are provided sterile, is identical to the predicate devices cleared under K180282. Validation of package integrity over the specified shelf life has been conducted according to methods described in ISO 11607-1:2009 (Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems) and ASTM F1929-12 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration). Results of the shelf-life validation of the package configuration support the specified shelf-life.
- Sterilization validation has been conducted on the gamma irradiation process utilized to sterilize the proposed dental implants which are provided sterile to the end user and on the steam sterilization process for the proposed abutments which are provided non-sterile and are intended to be sterilized by the end user. Sterilizations were conducted according to ANSI/AAMI/ISO 11137-1 (Sterilization Of Health Care Products - Radiation - Part 1: Requirements For Development, Validation, And Routine Control Of A Sterilization Process For Medical Devices) and ANSI/AAMI/ISO 11137-2 (Sterilization Of Health Care Products - Radiation -Part 2: Establishing The Sterilization Dose), for the irradiation process, as well as, ANSI/AAMI/ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices) and ANSI/AAMI/ISO 17665-2 (Sterilization Of Health Care Products - Moist Heat - Part 2: Guidance On The Application Of ANSI/AAMI/ISO 17665-1) for the steam sterilization process. The results of the sterilization validations support a minimum sterility assurance level (SAL) of 10-⁶.
Clinical Performance Data:
No human clinical data were included to support substantial equivalence.
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.
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December 11, 2019
Dentsply Sirona Inc. Karl Nittinger Vice President, Regulatory Affairs 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401
Re: K192149
Trade/Device Name: MIS Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 12, 2019 Received: September 13, 2019
Dear Karl Nittinger:
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 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.
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental 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
Indications for Use
510(k) Number (if known)
K192149
Device Name MIS Dental Implant System
Indications for Use (Describe)
MIS Dental Implant Systems are 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 short implants are to be used only with straight abutments.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Permitting Use (Part 21 CFR 601 Subpart E) | |
| Over-The-Counter Use (21 CFR 201.66) |
X 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/2 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 is in a simple, sans-serif font and is a dark gray color.
510(k) SUMMARY For: K192149 MIS Dental Implant System
1. Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
| Contact Name: | Karl Nittinger, Vice President, Corporate Regulatory Affairs |
|---|---|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 |
Date Prepared: November 19, 2019
2. Device Identification:
Trade/Proprietary Name: MIS Dental Implant System
| Classification Name: | Endosseous dental implant |
|---|---|
| Regulation Number: | 872.3640 |
| Primary Product Code: | DZE |
| Secondary Product Code: | NHA |
| Device Class: | Class II |
| Classification Panel: | Dental Devices Panel |
3. Predicate and Reference Devices
The predicate and reference devices that have been identified relating to the substantial equivalence of the proposed MIS Dental Implant System entailing a material modification and line extension of the MIS Lance+ Internal Hex Dental Implants and new offering of MIS Internal Hex Cobalt Chrome Abutments are:
| Primary Predicate Device | 510(k) | Manufacturer |
|---|---|---|
| Implants- MIS Internal Hex | ||
| Dental Implant System | K180282 | MIS Implants Technologies Ltd. |
| Reference Devices | 510(k) | Manufacturer |
| Implants and Abutments- MIS | ||
| Dental Implant System | K040807 | MIS Implants Technologies Ltd. |
| Abutments- Dentum Implantium/ | ||
| SuperLine Prosthetics | K160828 | Dentium Co., Ltd. |
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4. Device Description
Table 5.1 describes the proposed devices and their detailed modifications from their originally cleared 510(k) notifications.
| Table 5.1 | |
|---|---|
| Proposed Device | Proposed Modifications |
| Lance+ Internal Hex Implant System | Change material from originally cleared CP Titanium grade 4 to titanium alloy. Add the following implant diameter, length, platform combinations: 3.75 mm (DIA) x 8 mm (L), standard platform 4.20 mm (DIA) x 8 mm (L), standard platform 5.00 mm (DIA) x 8 mm (L), wide platform 6.00 mm (DIA) x 8 mm (L), wide platform 6.00 mm (DIA) x 10 mm (L), wide platform 6.00 mm (DIA) x 11.5 mm (L), wide platform 6.00 mm (DIA) x 13 mm (L), wide platform 3.30 mm (DIA) x 10 mm (L), narrow platform 3.30 mm (DIA) x 11.5 mm (L), narrow platform 3.30 mm (DIA) x 13 mm (L), narrow platform 3.30 mm (DIA) x 16 mm (L), narrow platform |
| MIS Internal Hex abutments | Add abutments in new material (CoCr) offered. 4.3 mm (DIA), narrow platform, anti-rotation 4.3 mm (DIA), narrow platform, free-rotation 5.0 mm (DIA), standard platform, anti-rotation 5.0 mm (DIA), standard platform, free-rotation 5.5 mm (DIA), wide platform, anti-rotation 5.5 mm (DIA), wide platform, free-rotation 4.8 mm (DIA), multi-unit, free rotation Post-casting specifications: 0° angulation for straight implantation only. 0.5 mm minimum wall thickness. 4 mm minimum post height. 1 mm minimum gingival collar |
Lance+ Dental Implants – The proposed MIS Lance+ Internal Hex implants are a modification and line extension to the originally cleared Lance implants (K040807). The proposed Lance+ implants are manufactured from titanium alloy, Ti- 6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant compared to the prior CP titanium grade 4. Apart from the change in material, additional sizes are being added as a line extension. Table 5.1 above summarizes the modifications being made. Both the subject Lance+ Internal Hex Implants and the originally cleared Lance implants (K040807) have identical intended use and similar indications for use.
5
MIS Internal Hex Cobalt Chrome (CoCr) abutments – The proposed MIS Internal Hex CoCr abutments are pre-manufactured prosthetic components directly connected to the endosseous dental implant and intended for use as an aid in prosthetic rehabilitation. They are intended for permanent restoration for single tooth or multiple units screw retained restorations. The lower part of the abutment, which connects directly to the implant, is made of CoCr alloy, and the upper part is made of plastic (POM). The plastic part is dissolved during the casting process. The abutment is connected to the implant by a prosthetic screw, supplied with the abutment.
5. Indications for Use
MIS Dental Implant Systems are 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 short implants are to be used only with straight abutments.
6. Substantial Equivalence Discussion
MIS Lance+ Internal Hex implants:
For the purposes of substantial equivalence, the proposed MIS Lance+ Internal Hex Implants are compared to the predicate device MIS Internal Hex Implant System (K180282) and the originally cleared predicate MIS Dental Implant System (K040807-includes originally cleared Lance implants). The comparison table below (Table 5.2) summarizes the proposed implants to the predicate devices with respect to indications for use, principles of operation, technological characteristics, and performance testing to demonstrate that the data provided for the proposed implants supports equivalence to the predicate devices.
6
Table 5.2- Comparison of Implant Characteristics – Proposed MIS Lance+ Internal Hex implants and the predicate devices:
| Trade Name | MIS Dental Implant System
(Lance+ Internal Hex Implants) | MIS Internal Hex Dental Implant
System
K180282 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use: | MIS dental implant systems are
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 | MIS dental implant systems are
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 |
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.
Proposed Device
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 long MIS (18 & 20 mm) implants can be used in a tilted manner. MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only.
Predicate Device
The MIS dental implant system is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
Reference Device
MIS Dental Implant System (includes originally cleared Lance implants) K040807
Similarities/Differences
Identical to predicate device K180282 with the exception of the reference in the predicate device (K180282) indications for use to the short M4 implants and UNO Narrow implants and to 18 mm and 20 mm length implants. The M4 and UNO implant variants, as well as the 18 mm and 20 mm length MIS implants are not within the scope of the offerings of the proposed device.
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| Table 5.2- Comparison of Implant Characteristics - Proposed MIS Lance+ Internal Hex implants and the predicate devices: | ||||||
|---|---|---|---|---|---|---|
| Trade Name | Proposed Device | |||||
| MIS Dental Implant System | ||||||
| (Lance+ Internal Hex Implants) | Predicate Device | |||||
| MIS Internal Hex Dental Implant | ||||||
| System | ||||||
| K180282 | Reference Device | |||||
| MIS Dental Implant System | ||||||
| (includes originally cleared | ||||||
| Lance implants) | ||||||
| K040807 | Similarities/Differences | |||||
| Endosseous | ||||||
| Implant | ||||||
| Material(s) | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | CP Titanium grade 4 | Identical to predicate device K180282. | ||
| Surface | ||||||
| Treatment | Sand blasted and acid etched | Sand blasted and acid etched | Sand blasted and acid | |||
| etched | No Difference | |||||
| Connection | ||||||
| Type | Internal hexagon | Internal hexagon | Internal hexagon | No difference | ||
| Body design | Tapered, conical shape, threaded | Tapered, conical shape, threaded | Tapered, conical shape, | |||
| threaded | No difference. | |||||
| Neck Design | Cylindrical, no micro-rings | Cylindrical, with micro-rings (Seven | ||||
| Implants) and Cylinder (M4 Implants) | Cylindrical, no micro-rings | No difference from the predicate device K040807. | ||||
| Apex | Domed | Domed (Seven Implants) and Flat (M4 | ||||
| Implants) | Domed | No difference. Domed apex configuration offered in | ||||
| predicate device K180282 and K040807. | ||||||
| Thread | Triple | Dual | Triple | No difference from the predicate device K040807. | ||
| 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 | Identical to platform offerings of predicate device | |||
| K180282. | ||||||
| Implant | ||||||
| Diameters | 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, 6.00 mm | ||||||
| NP: Ø 3.30 mm | SP: Ø 3.75 mm, 4.20 mm | |||||
| WP: Ø 5.00 mm | Identical to the platform offerings of predicate | |||||
| device K180282. | ||||||
| Implant | ||||||
| Lengths | 8, 10, 11.5, 13, 16 mm | 8, 10, 11.5, 13, 16, 18, 20 mm | 10, 11.5, 13, 16 mm | Length range offering is within the range of the | ||
| predicate devices. | ||||||
| Sterilization | ||||||
| Method | Radiation | Radiation | Radiation | No differences. |
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MIS Internal Hex Cobalt Chrome (CoCr) abutments
The proposed MIS Internal Hex CoCr abutments are compared to the abutment offereing their predicate and reference devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing (see Table 5.3).
Geometrically, these abutments are identical to the predicate MIS Internal Hex Gold abutments (K180282) but differ in terms of material. The difference in material of the proposed abutments is accounted for by comparing to the material used for the reference device of Dentum Implantium/SuperLine Prosthetics (K160828). Both the proposed MIS Internal Hex CoCr abutments and the predicate MIS Internal Hex Gold abutments (K180282) are provided in all three platforms, and either have a free-rotation or an antirotation configuration. The intended use and indications for use are the same, as well as the gingival height, and the indication for 0 degree angulation for straight implantation only. Both the proposed MIS Internal Hex CoCr abutments and the predicate MIS Internal Hex Gold abutments (K180282) connect directly to the implant in the same internal hex connection, and are provided non sterile, to be sterilized by the user. The main difference is the composition of a new material, which is provided by the reference device (K160828), having the same intended use and similar indications for use. Furthermore, testing in the form of cytotoxicity tests and corrosion tests are provided to support equivalence to the predicate and reference devices.
Table 5.3- Comparison of abutment Characteristics - proposed MIS Internal Hex CoCr abutments and predicate/reference devices:
| Proposed Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Trade Name | MIS Dental Implant System | ||
| (Internal Hex Cobalt Chrome Abutments) | MIS internal Hex Gold Abutments | ||
| K180282 | Dentum Implantium/ SuperLine | ||
| Prosthetics | |||
| K160828 | |||
| Indications | |||
| for use | MIS dental implant systems are 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 ( $\text{\O}3.3$ mm) 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. | MIS dental implant systems are 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 ( $\text{\O}3.3$ mm & 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. | |||
| Mandibular central and lateral incisors must | |||
| be splinted if using two or more narrow | |||
| implants adjacent to one another. The long | |||
| MIS (18 & 20 mm) implants can be used in a | |||
| tilted manner. MIS short implants are to be | |||
| used only with straight abutments. MIS M4 | |||
| short implants are indicated for delayed | |||
| loading only. | Dentium Implantium & SuperLine | ||
| Prosthetics are intended for use as | |||
| an aid in prosthetic rehabilitation. |
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| Table 5.3- Comparison of abutment Characteristics - proposed MIS Internal Hex CoCr abutments and | |||
|---|---|---|---|
| predicate/reference devices: | |||
| Trade Name | Proposed Device | ||
| MIS Dental Implant System | |||
| (Internal Hex Cobalt Chrome Abutments) | Predicate Device | ||
| MIS internal Hex Gold Abutments | |||
| K180282 | Reference Device | ||
| Dentum Implantium/ SuperLine | |||
| Prosthetics | |||
| K160828 | |||
| Material(s) | Abutment base: | ||
| Cobalt-Chromium alloy | |||
| Plastic cylinder: Polyoxymethylene (POM) | |||
| Prosthetic screw: | |||
| Ti 6Al 4V ELI per ASTM F136 | Abutment base: | ||
| Gold alloy. | |||
| Plastic cylinder: Polyoxymethylene (POM) | |||
| Prosthetic screw: | |||
| Ti 6Al 4V ELI per ASTM F136 | Abutment base: Cobalt-Chromium | ||
| alloy | |||
| Plastic cylinder: unknown | |||
| Connection | |||
| Type | Internal hexagon | Internal hexagon | Conical hex |
| Angulation | 0° | 0° | 0° |
| Sterilization | Product provided non-sterile | Product provided non-sterile | Product provided non-sterile |
7. Non-Clinical Performance Data
As part of demonstrating the substantial equivalence of the proposed MIS Lance+ Dental implant System and the proposed MIS Internal Hex CoCr abutments to the predicate and reference devices, MIS Implants Technologies completed a number of non-clinical performance tests:
- . Fatigue Testing - Mechanical testing of the proposed MIS Lance+ Internal Hex implants in accordance to ISO 14801:2016 was conducted. 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.
- . CoCr corrosion testing - All tested dental metal alloys have very low corrosion rates, with the lowest corrosion rate achieved for the CoCr-titanium couple, indicating that in physiological conditions the CoCr presents low risk of galvanic corrosion when coupled with titanium. The test establishes the proposed MIS Internal Hex CoCr abutments as having no risk for corrosion.
- . Biocompatibility Testing- The proposed MIS Lance+ Internal Hex Implants are made from the same materials, under the same processing conditions and at the same manufacturing location as the predicate device, MIS Internal Hex Dental Implants (K180282). Therefore, no further biocompatibility testing was conducted in support of substantial equivalence. Biocompatibility testing (cytotoxicity) was conducted on the proposed MIS Internal Hex CoCr Abutments and results supported a conclusion non-cytotoxicity.
- Surface treatment of the proposed implants is identical to the surface treatment of the predicate device implants cleared under K180282 and the reference device implants cleared under K040807. Characterization of the surface treatment is provided with reference to the May, 2004, Guidance for Industry an FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
- . Packaging configuration of the proposed dental implants, which are provided sterile, is identical to the predicate devices cleared under K180282. Validation of package integrity over the specified shelf life has been conducted according to methods described in ISO 11607-1:2009 (Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
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barrier systems and packaging systems) and ASTM F1929-12 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration). Results of the shelf-life validation of the package configuration support the specified shelf-life.
- Sterilization validation has been conducted on the gamma irradiation process utilized to sterilize the proposed dental implants which are provided sterile to the end user and on the steam sterilization process for the proposed abutments which are provided non-sterile and are intended to be sterilized by the end user. Sterilizations were conducted according to ANSI/AAMI/ISO 11137-1 (Sterilization Of Health Care Products - Radiation - Part 1: Requirements For Development, Validation, And Routine Control Of A Sterilization Process For Medical Devices) and ANSI/AAMI/ISO 11137-2 (Sterilization Of Health Care Products - Radiation -Part 2: Establishing The Sterilization Dose), for the irradiation process, as well as, ANSI/AAMI/ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices) and ANSI/AAMI/ISO 17665-2 (Sterilization Of Health Care Products - Moist Heat - Part 2: Guidance On The Application Of ANSI/AAMI/ISO 17665-1) for the steam sterilization process. The results of the sterilization validations support a minimum sterility assurance level (SAL) of 10-°.
8. Clinical Performance Data
No human clinical data were included to support substantial equivalence.
9. Conclusion Regarding Substantial Equivalence
The proposed MIS Lance+ Internal Hex Dental implants and the proposed MIS Internal Hex Cobalt Chrome abutments have the same intended use, incorporate the same fundamental technology, and have similar indications for use as the predicate and reference devices. The results of the testing included in this premarket notification support a determination of substantialequivalence.