(230 days)
No
The 510(k) summary describes a dental implant system with modifications only to its packaging configuration (liquid in the inner tube). There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The document explicitly states the intended use as being surgically placed in the bone to support prosthetic devices to restore masticatory function. Restoring function is a therapeutic action.
No
Explanation: The device is an implant system used to provide support for prosthetic devices (artificial teeth) and restore masticatory function, not to diagnose a condition.
No
The device is a physical dental implant system, not software. The 510(k) describes modifications to the packaging and the inclusion of a liquid solution, not software components.
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 implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details a physical implant device and its packaging, not a reagent, instrument, or system intended for in vitro diagnostic use.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting markers, or providing diagnostic information.
The device is a dental implant, which is a medical device used for surgical and restorative purposes.
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.
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.
Product codes
DZE
Device Description
The subject MIS Dental Implant Systems are endosseous dental implant devices which are modified as subject to this premarket notification with a revised sterile packaging configuration. There are no modifications subject to this premarket notification which relate to the geometric or material composition design of the subject dental implant devices themselves.
The individual product variants of the MIS Dental Implant Systems which are modified as subject to this premarket notification will be rebranded "MIS CLEAR".
The subject implants are identical to the predicate and reference MIS implant systems in terms of their indications for use, design, constituent materials and manufacturing process. The subject MIS Dental Implant Systems only differ in their final packaging configuration, as subject to this premarket notification. The subject, predicate and reference MIS Dental Implants Systems are supplied in a double tube packaging configuration, wherein the outer tube serves as the sterile barrier, and the implant device is located within the inner tube. While the predicate and reference MIS Dental Implants Systems are supplied within a "dry" inner package tube, the subject devices as modified in this premarket notification are supplied in a modified inner tube containing liquid, in the form of NaCl solution. The liquid environment is intended to maintain the super-hydrophilic property (contact angle exhibited by water in contact with the surface is equal to zero degrees) of the subject MIS Dental Implants Systems, as subject to this premarket notification, until their use in patients. The outer tube serving as the sterile barrier is unchanged compared to the predicate and reference devices.
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
dental clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data submitted, referenced, or relied upon to support substantial equivalence includes:
- Cytotoxicity: Cytotoxicity testing was performed to verify that no toxic materials are present on the subject dental implants, even after they are immersed in the NaCl solution in the proposed packaging following a one year accelerated shelf-life simulation. Data supports no cytotoxic effects are present in the subject dental implants.
- Chemical Characterization: Testing in the form of Chemical Characterization was performed to assure no foreign materials are found on the subject dental implants following the transition to the proposed packaging configuration. Data supports that no foreign or unexpected materials are present on the subject dental implants following one year accelerated shelf-life simulation.
- Sterilization: A full sterilization validation test was performed to establish the sterilization dose used for the proposed packaging configuration achieves sterility assurance level (SAL) of at least 10⁻⁶, in accordance with ISO 11137-1:2015 and ISO 11137-2:2015. The testing showed that the bioburden, the sterility test and the endotoxin assay met the predetermined requirements.
- Transportation: A transportation simulation followed by visual inspection were made to assure the proposed packaging modification survives transportation conditions, in accordance with ASTM 4332-14 and ASTM D 4169-16. As the outer packaging and packaging materials constituting the sterile barrier are unchanged and are identical to the outer packaging used for the predicate and reference MIS dental implant devices, shelf life and package integrity validations are referenced to support substantial equivalence.
- Hydrophilicity testing: In order to establish that the super-hydrophilic characteristic of the subject dental implants are maintained throughout the life-time of the implants, hydrophilicity testing was performed following one year accelerated shelf-life simulations. Data supports the subject dental implants preserve their super-hydrophilic properties even after one year accelerated shelf-life.
- Fatigue Testing: It is maintained that the NaCl environment of the subject implants should have no affect over the mechanical endurance limit of the implants. Since there were no changes in the implants' design when compared to the reference devices, mechanical testing of the predicate devices in accordance to ISO 14801:2016 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants is referenced to support substantial equivalence in K112162, K172505, K164439, K180282 and K192149.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K192149, K172505, K163349, K112162, K140878
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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September 3, 2020
Dentsply Sirona Karl Nittinger Vice President, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401
Re: K200102
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 Dated: September 2, 2020 Received: September 3, 2020
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
542 of the Act); 21 CFR 1000-1050.
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 (OS) 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-
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.
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200102
Device Name MIS Dental Implant Systems
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 (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.
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
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 similar color to the leaf-like shape.
510(k) SUMMARY For MIS Dental Implant Systems
1.0 Submitter Information:
Dentsply Sirona Inc. 221 West Philadelphia Street Suite 60W York, PA 17401
| Contact Person: | Karl Nittinger |
|---|---|
| Email: | karl.nittinger@dentsplysirona.com |
| Telephone Number: | 717-487-4424 |
| Fax Number: | 717-849-4343 |
Date Prepared: 03 - September - 2020
2.0 Device Name:
- Proprietary Name: MIS Dental Implant Systems ●
- Classification Name: Endosseous dental implant
- CFR Number: 872.3640
- Device Class: Class II
- Product Code: DZE �
3.0 Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| MIS Internal Hex Dental Implant System | ||
| (MIS SEVEN Internal Hex Dental Implant System) | K180282 | MIS Implants Technologies Ltd. |
| (Dentsply Sirona) | ||
| Reference Device Name | 510(k) | Company Name |
| MIS Dental Implant System | ||
| (MIS Lance+ Internal Hex Dental Implant System) | K192149 | MIS Implants Technologies Ltd. |
| (Dentsply Sirona) | ||
| MIS C1 Narrow Platform Conical Connection Dental | ||
| Implant System, MIS C1 Wide Platform Conical | ||
| Connection Abutments | ||
| (MIS C1 Conical Connection Dental Implant System) | K172505 | MIS Implants Technologies Ltd. |
| (Dentsply Sirona) | ||
| MIS V3 Conical Connection Dental Implant System | K163349 | MIS Implants Technologies Ltd. |
| (Dentsply Sirona) | ||
| Conical Connection Implants | K112162 | MIS Implants Technologies Ltd. |
| (Dentsply Sirona) | ||
| Straumann® Bone Level Tapered Implant | K140878 | Institute Straumann AG |
4.0 Device Description
The subject MIS Dental Implant Systems are endosseous dental implant devices which are modified as subject to this premarket notification with a revised sterile packaging configuration. There are no modifications subject to this premarket notification which relate to the geometric or material composition design of the subject dental implant devices themselves.
4
The individual product variants of the MIS Dental Implant Systems which are modified as subject to this premarket notification will be rebranded "MIS CLEAR".
The subject implants are identical to the predicate and reference MIS implant systems in terms of their indications for use, design, constituent materials and manufacturing process. The subject MIS Dental Implant Systems only differ in their final packaging configuration, as subject to this premarket notification. The subject, predicate and reference MIS Dental Implants Systems are supplied in a double tube packaging configuration, wherein the outer tube serves as the sterile barrier, and the implant device is located within the inner tube. While the predicate and reference MIS Dental Implants Systems are supplied within a "dry" inner package tube, the subject devices as modified in this premarket notification are supplied in a modified inner tube containing liquid, in the form of NaCl solution. The liquid environment is intended to maintain the super-hydrophilic property (contact angle exhibited by water in contact with the surface is equal to zero degrees) of the subject MIS Dental Implants Systems, as subject to this premarket notification, until their use in patients. The outer tube serving as the sterile barrier is unchanged compared to the predicate and reference devices.
5.0 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.
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.
6.0 Substantial Equivalence Discussion
A comparative summary of the similarities and differences between the indications for use of the subject and predicate device is given in Table 6.1 below. The subject indications for use are inclusive of the full MIS Dental Implant System. Table 6.2 compares the technological characteristics of the subject MIS Dental Implant Systems with the predicate and reference implant systems. Under this premarket notification, there is no change in the implants themselves. The only change under this premarket notification is the modification to the inner packaging of the implants.
5
| Table 6.1-Indications for Use Comparison | ||
|---|---|---|
| Subject Device | ||
| MIS Dental Implant Systems | Predicate Device | |
| MIS Dental Implant Systems | ||
| (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 ( $Ø$ 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 in 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. | 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 ( $Ø$ 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 in 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. |
6
| Table 6.2: Technological Characteristics comparison between the subject, predicate and reference Implant devices | ||||
|---|---|---|---|---|
| Subject Device | ||||
| MIS Dental Implant Systems | Predicate Device | |||
| MIS Internal Hex Dental Implant | ||||
| Systems | ||||
| K180282 | Reference Devices | |||
| MIS Dental Implant Systems | ||||
| K192149, K172505, K163349, K112162 | Reference Device | |||
| Straumann® Bone Level Tapered | ||||
| Implant | ||||
| K140878 | ||||
| Manufacturer | MIS Implants Technologies Ltd. | |||
| (Dentsply Sirona) | MIS Implants Technologies Ltd. | |||
| (Dentsply Sirona) | MIS Implants Technologies Ltd. | |||
| (Dentsply Sirona) | Institute Straumann AG | |||
| Connection Type | Internal hexagon or Conical | |||
| connection | Internal hexagon | Internal hexagon (K192149) | ||
| Conical connection | ||||
| (K172505,K163349,K112162) | Narrow CrossFit® (NC) Regular | |||
| CrossFit® (RC) | ||||
| Material(s) | Titanium Alloy | Titanium Alloy | Titanium Alloy | CP Titanium Grade 4 |
| Surface | ||||
| Treatment | Anodized, sand blasted, and acid | |||
| etched | Anodized, sand blasted, and acid etched | Anodized, sand blasted, and acid etched | ||
| (K172505, K163349, K112162) | ||||
| Sand blasted and acid etched (K192149) | Sand blasted and acid etched | |||
| Body Design | Tapered, threaded | Tapered, threaded | Tapered, threaded | Tapered, threaded |
| Implant | ||||
| Diameters | C1 Implants: 3.30, 3.75, 4.20, | |||
| 5.00 mm | ||||
| V3 Implants: 3.30, 3.90, 4.30, | ||||
| 5.00 mm | ||||
| SEVEN Implants: 3.30, 3.75. | ||||
| 4.20, 5.00, 6.00 mm | ||||
| Lance+ Implants: 3.30, 3.75, | ||||
| 4.20, 5.00, 6.00 mm | M4 and SEVEN Implants: | |||
| 3.30, 3.75, 4.20, 5.00, 6.00 mm. | C1 Implants: 3.30, 3.75, 4.20, 5.00 mm | |||
| V3 Implants: 3.30, 3.90, 4.30, 5.00 mm | ||||
| Lance+ Implants: 3.30, 3.75, 4.20, 5.00, | ||||
| 6.00 mm | 3.3, 4.1, 4.8 mm | |||
| Implant Lengths | 8, 10, 11.5, 13, 16, 18, 20 mm | 8, 10, 11.5, 13, 16, 18, 20 mm | 8, 10, 11.5, 13, 16 mm | 8, 10, 12, 14, 16 mm |
| Inner Package | ||||
| Medium | NaCl solution | Air | Air | NaCl solution |
| Table 6.2: Technological Characteristics comparison between the subject, predicate and reference Implant devices | ||||
| Subject Device | ||||
| MIS Dental Implant Systems | Predicate Device | |||
| MIS Internal Hex Dental Implant | ||||
| Systems | ||||
| K180282 | Reference Devices | |||
| MIS Dental Implant Systems | ||||
| K192149, K172505, K163349, K112162 | Reference Device | |||
| Straumann® Bone Level Tapered | ||||
| Implant | ||||
| K140878 | ||||
| Reusability | Single use | Single use | Single use | Single use |
| Sterilization | ||||
| Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
7
As shown in the summary companson of technological characteristics in Table 6.2, the subject to this premarket notification are identical in design to the predicate (K192149, K172505, K163349, K112162) devices. The subject MIS Implants Systems are comprised of the same MIS implants ("C1", "V3", "SEVEN", and "Lance+") as are the predicate (K180282) and reference (K192149, K172505, K16349, and K12162) devices. There are no design modifications to the insplant to this premarket notification and therefore, the subject Systems devices composed of the identical titanium alloy material, feature the identical anodized, sand blasted, and acid etched surface treatment, and are characterized by the identical tody design as do the predicate (K180282) and reference (K192149, K172505, K163349, and K112162) devices.
The subject MIS Implants Systems devices and the predicate (K180282) and reference (K192149, K112162) devices are offered in diameters of 3.30 mm - 6.00 mm and in imm -20 mm. The sole difference of the MIS Implant Systems devices as subject to this premarket notification is the fact that, unlike the predicate (K19214), K172505, K16349, K112162) devices, the subject devices are packed in a medium of NaCl solution within their sterile barrier.
The Straumann Bone Level Tapered device (K140878) is included in support of substantial equivalence for the purpose of identifying a cleared dental implant with the same interial composition (commercially pure titanium), similar geometric design (implant diameters and lengths ranges are within those of the subject MIS Dental Implant Systems) and also immersed within the sterile barrier in a NaCl solution.
As summarized in Section 7.0 of this 510(k) Summary, non-clinical testing to the package configuration difference between the subject MIS Dental Implant Systems and the predicate (K192149, K172505, K16349, K112162) devices and the results of these non-clinical studies support substantial equivalence.
8
7.0 Non-Clinical Performance Data
Non-clinical testing data submitted, referenced, or relied upon to support substantial equivalence includes:
- Cytotoxicity: Cytotoxicity testing was performed to verify that no toxic materials are present on . the subject dental implants, even after they are immersed in the NaCl solution in the proposed packaging following a one year accelerated shelf-life simulation. Data supports no cytotoxic effects are present in the subject dental implants.
- . Chemical Characterization: Testing in the form of Chemical Characterization was performed to assure no foreign materials are found on the subject dental implants following the transition to the proposed packaging configuration. Data supports that no foreign or unexpected materials are present on the subject dental implants following one year accelerated shelf-life simulation.
- Sterilization: A full sterilization validation test was performed to establish the sterilization dose ● used for the proposed packaging configuration achieves sterility assurance level (SAL) of at least 10°, in accordance with ISO 11137-1:2015 and ISO 11137-2:2015. The testing showed that the bioburden, the sterility test and the endotoxin assay met the predetermined requirements.
- Transportation: A transportation simulation followed by visual inspection were made to assure the proposed packaging modification survives transportation conditions, in accordance with ASTM 4332-14 and ASTM D 4169-16. As the outer packaging and packaging materials constituting the sterile barrier are unchanged and are identical to the outer packaging used for the predicate and reference MIS dental implant devices, shelf life and package integrity validations are referenced to support substantial equivalence.
- Hydrophilicity testing: In order to establish that the super-hydrophilic characteristic of the subject dental implants are maintained throughout the life-time of the implants, hydrophilicity testing was performed following one year accelerated shelf-life simulations. Data supports the subject dental implants preserve their super-hydrophilic properties even after one year accelerated shelf-life.
- Fatigue Testing: It is maintained that the NaCl environment of the subject implants . should have no affect over the mechanical endurance limit of the implants. Since there were no changes in the implants' design when compared to the reference devices, mechanical testing of the predicate devices in accordance to ISO 14801:2016 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants is referenced to support substantial equivalence in K112162, K172505, K164439, K180282 and K192149.
8.0 Clinical Performance Data
No human clinical data was included in this premarket notification to support the substantial equivalence of the subject MIS Dental Implant Systems to the predicate and reference MIS Dental Implant Systems (K112162, K172505, K163349, K180282, K192149).
- 9.0 Conclusion Regarding Substantial Equivalence
The subject MIS Dental Implant Systems are endosseous dental implants which are intended to be used by dental clinicians for prosthetic restoration in the maxilla and mandible. The subject devices incorporate the same fundamental technology and intended use as the predicate and reference MIS implants. The proposed indications for use are inclusive of the full MIS Dental Implant System.
Non-clinical bench testing has been conducted and included in this premarket notification to demonstrate the performance of the subject MIS Dental Implant Systems against their design, functional and safety requirements. The comparison of the indications for use, technological characteristics, with the inclusion of the results of nonclinical testing, support a conclusion of substantial equivalence of the subject MIS Dental Implant Systems to the predicate and reference devices.