(141 days)
No
The summary describes a line extension of dental abutments and superstructures, focusing on mechanical properties, biocompatibility, and sterilization. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is a dental implant system (abutments and superstructures) used to support prosthetic dental restorations and restore masticatory function, rather than to treat or cure a disease or condition.
No.
The device is intended to provide support for prosthetic devices to restore masticatory function, making it a restorative and support device, not a diagnostic one.
No
The device description clearly states the device consists of physical components (dental abutments and superstructures) made of materials that undergo fatigue testing, biocompatibility testing, and sterilization validation. There is no mention of software as the primary or sole component.
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 devices are "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." This describes a surgical implant and prosthetic support system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details dental abutments and superstructures that are physically placed within the mouth to support artificial teeth. This is consistent with a medical device used for structural support and restoration, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic devices.
Therefore, the information provided strongly indicates that this device is a dental implant system and related components, which are considered medical devices but not IVDs.
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 (Ø3.3 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, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
Product codes
NHA
Device Description
The proposed devices consist of dental abutments and represent a line extension to the MIS CONNECT Conical Connection System.
4.1 MIS CONNECT Conical Connection Abutments
The proposed MIS CONNECT Conical Connection Abutments are intended for use by dental clinicians in the support of prosthetic dental restorations in the upper or lower jaw and used in conjunction with MIS conical connection implants, MIS V3 and MIS C1 (K163349 and K112162, respectively).
The abutment is placed above the bone level and within the gingival tissue, and is designed to be fitted with a variety of complementary abutment superstructures, including caps, temporary abutments, aesthetic abutments, final abutments, and angulated abutments. Prosthetic screws are included as a system component for use with the subject abutments.
Once connected to the implant, the MIS CONNECT Conical Connection Abutment is not intended to be removed.
The abutments are provided in 4.0 and 5.7 mm platform diameters, with an angulation of up to 20°, and at gingival heights of 1.5, 2.0, 3.0, and 4.0 mm.
MIS CONNECT Conical Connection Superstructures 4.2
The proposed MIS CONNECT Conical Connection Superstructures are mounted over the proposed and predicate MIS CONNECT Conical Connection Abutment (Ø4 mm or Ø5.7 mm) and intended for use as an aid in prosthetic dental restoration. The proposed superstructures consist of healing caps, temporary abutments, aesthetic abutments, final abutments, and angulated abutments. Prosthetic screws are included as a system component for use with the subject superstructures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 demonstrate substantial equivalence includes:
- Fatigue testing: Dynamic fatigue testing of worst case representative samples of the proposed MIS CONNECT Conical Connection Abutments (line extension to the predicate) and superstructures was performed in accordance to ISO 14801:2016 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants. The results of the fatgue testing support substantial equivalence.
- Biocompatibility: The proposed devices are composed of the identical materials and are ● manufactured in the identical manufacturing facility and under the identical manufacturing processes as the primary predicate device (K173326). In addition, the intended conditions of use and patient contact type and duration of contact (as per ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) for the proposed devices are identical to that of the primary predicate device (K173326). Therefore, no new biocompatibility data are included in support of substantial equivalence.
- Sterilization: Sterilization validation of sterile devices was conducted for worst-case construct . according to ISO 11137-2:2013, Sterilization of health care products- Radiation- Part 2: Establishing the sterilization dose. The results of the sterilization support a conclusion that a sterility assurance level (SAL) of 10-6 is achieved under the sterilization parameters utilized.
Sterilization validation of non-sterile devices was conducted for worst-case construct according to ANSI/AAMI/ISO 17665-1:2006/(R)2013, Sterilization of health care products - Moist Heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. The results of the sterilization support a conclusion that a sterility assurance level (SAL) of 10-6 is achieved under the sterilization parameters utilized by the enduser. - Packaging and packaging materials are the identical for the predicate and proposed devices. Thus, ● shelf life data are referenced by equivalence to support substantial equivalence.
No human clinical data were included in this premarket notification to support the substantial equivalence of the proposed line extension to predicate MIS CONNECT Connection Abutments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
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Image /page/0/Picture/0 description: The image shows 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.
March 25, 2020
Dentsply Sirona Karl Nittinger Vice President, Corporate Regulatory Affairs 221 W Philadelphia Street, Suite 60W York, Pennsylvania 17401
Re: K193078
Trade/Device Name: MIS CONNECT Conical Connection System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 2, 2020 Received: March 2, 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
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 531-542 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.
Srinivas Nandkumar, Ph.D. for 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) K193078
Device Name MIS CONNECT Conical Connection 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 (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, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
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Section 4-2
3
Dentsply Sirona Inc. 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, abstract shape on the left, resembling a curved, segmented leaf or a stylized letter 'S'. To the right of the shape are the words "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is aligned with the right edge of the abstract shape.
510(k) SUMMARY K193078 MIS CONNECT Conical Connection System
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: | 06 March 2020 |
2.0 Device Name:
- Proprietary Name: MIS CONNECT Conical Connection System
- Classification Name: Endosseous dental implant abutment
- CFR Number: 21 CFR 872.3630
- Device Class: ● Class II
- � Product Code: NHA
3.0 Predicate Device:
| Primary Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| MIS CONNECT Conical Connection | ||
| abutment | K173326 | MIS Implants Technologies Ltd. |
| (Owner/Operator : Dentsply Sirona) | ||
| Reference Devices: | 510(k) | Company Name |
| MIS V3 Cement Retained Abutment | K163349 | MIS Implants Technologies Ltd. |
| (Owner/Operator : Dentsply Sirona) | ||
| MIS C1 Narrow Platform Conical | ||
| Connection Implant System, MIS C1 | ||
| Wide Platform Conical Connection | ||
| Abutments | K172505 | MIS Implants Technologies Ltd. |
| (Owner/Operator : Dentsply Sirona) | ||
| MIS Conical Connection Implants | ||
| (Included as a referenced device solely for | ||
| identification as the compatible implant | ||
| system). | K112162 | MIS Implants Technologies Ltd. |
| (Owner/Operator : Dentsply Sirona) |
4.0 Device Description
The proposed devices consist of dental abutments and represent a line extension to the MIS CONNECT Conical Connection System.
4
4.1 MIS CONNECT Conical Connection Abutments
The proposed MIS CONNECT Conical Connection Abutments are intended for use by dental clinicians in the support of prosthetic dental restorations in the upper or lower jaw and used in conjunction with MIS conical connection implants, MIS V3 and MIS C1 (K163349 and K112162, respectively).
The abutment is placed above the bone level and within the gingival tissue, and is designed to be fitted with a variety of complementary abutment superstructures, including caps, temporary abutments, aesthetic abutments, final abutments, and angulated abutments. Prosthetic screws are included as a system component for use with the subject abutments.
Once connected to the implant, the MIS CONNECT Conical Connection Abutment is not intended to be removed.
The abutments are provided in 4.0 and 5.7 mm platform diameters, with an angulation of up to 20°, and at gingival heights of 1.5, 2.0, 3.0, and 4.0 mm.
MIS CONNECT Conical Connection Superstructures 4.2
The proposed MIS CONNECT Conical Connection Superstructures are mounted over the proposed and predicate MIS CONNECT Conical Connection Abutment (Ø4 mm or Ø5.7 mm) and intended for use as an aid in prosthetic dental restoration. The proposed superstructures consist of healing caps, temporary abutments, aesthetic abutments, final abutments, and angulated abutments. Prosthetic screws are included as a system component for use with the subject superstructures.
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 (Ø3.3 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, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
6.0 Substantial Equivalence Discussion
6.1 MIS CONNECT CONICAL CONNECTION ABUTMENTS
A summary of the similarities and differences between the proposed and predicate abutment devices is given in Table 6.1 below. A discussion of the similarities and differences follows Table 6.1.
5
| Table 6.1: Similarities and Differences between the proposed and predicate Abutment devices | |||
|---|---|---|---|
| Element | MIS CONNECT Conical | ||
| Connection abutments | |||
| Proposed device | MIS CONNECT Conical | ||
| Connection abutments | |||
| K173326 | |||
| Primary Predicate Device | MIS V3 Cement Retained | ||
| Abutments | |||
| K163349 | |||
| Reference Device | |||
| Pictorial | |||
| Representation | Image: MIS CONNECT Conical Connection abutments | Image: MIS CONNECT Conical Connection abutments K173326 | Image: MIS V3 Cement Retained Abutments K163349 |
| Intended use: | Dental implant abutments are | ||
| intended to be used in the upper | |||
| or lower jaw for supporting | |||
| tooth replacements to restore | |||
| chewing function. | |||
| The MIS CONNECT abutments | |||
| in combination with endosseous | |||
| implants are indicated for single | |||
| or multiple unit reconstructions | |||
| when screw retained prosthetics | |||
| are preferred. | Dental implant abutments are | ||
| intended to be used in the upper | |||
| or lower jaw for supporting tooth | |||
| replacements to restore chewing | |||
| function. | |||
| The MIS CONNECT abutments | |||
| in combination with endosseous | |||
| implants are indicated for single | |||
| or multiple unit reconstructions | |||
| when screw retained prosthetics | |||
| are preferred. | 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 cement-retained | |||
| supra-constructions. | |||
| 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, in order | |||
| to restore the patient chewing | |||
| function. Mandibular central | |||
| and lateral incisors must be | |||
| splinted if using two or more | |||
| narrow implants adjacent to one | |||
| another. | 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, in | |||
| order to restore the patient | |||
| chewing function. Mandibular | |||
| central and lateral incisors must | |||
| be splinted if using two or more | |||
| narrow implants adjacent to one | |||
| another. | MIS Dental Implant System 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, in | |||
| order to restore the patient | |||
| chewing function. Mandibular central | |||
| and lateral incisors must | |||
| be splinted if using two or more | |||
| narrow implants adjacent to one | |||
| another | |||
| Material(s) | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 |
| Table 6.1 (continued): Similarities and Differences between the proposed and predicate | |||
| Abutment devices | |||
| Element | MIS CONNECT Conical | ||
| Connection abutments | MIS CONNECT Conical | ||
| Connection abutments | |||
| K173326 | MIS V3 Cement Retained | ||
| Abutments | |||
| K163349 | |||
| Proposed device | Primary Predicate Device | Reference Device | |
| Surface | |||
| Treatment | Anodized after machining | Anodized after machining | Polished and anodized after |
| machining | |||
| Type of | |||
| Connection to | |||
| the Implant | Conical connection | ||
| without indexes | Conical connection | ||
| without indexes | Conical connection | ||
| NP: 3 indexes | |||
| SP: 6 indexes | |||
| Type of | |||
| Connection to | |||
| the | |||
| Superstructure | Internal connection | ||
| Anti-rotation: 12 indexes | |||
| Free-rotation: no indexes | Internal connection | ||
| Anti-rotation: 3 indexes | |||
| Free-rotation: no indexes | NA - the crown is cemented | ||
| directly onto the abutment post. | |||
| Compatible | |||
| implant | |||
| platforms | MIS CONNECT Ø4 abutment: | ||
| NP, SP, WP | |||
| MIS CONNECT Ø5.7 | |||
| abutment: SP, WP | NP, SP, WP | NP, SP, WP | |
| Gingival | |||
| Height | NP: 2, 3 mm | ||
| SP: 1.5, 2, 3, 4 mm | |||
| WP: 1.5, 2, 3, 4 mm | NP: 2, 3 mm | ||
| SP: 1.5, 2, 3, 4 mm | |||
| WP: 1.5, 2, 3, 4 mm | 0.5, 1, 1.5, 2, 3 mm | ||
| Post height | NA – the MIS CONNECT does | ||
| not have a post for prosthetic | |||
| reconstruction, but is configured | |||
| to be mounted with a | |||
| superstructure having a post. | NA – the MIS CONNECT does | ||
| not have a post for prosthetic | |||
| reconstruction, but is configured | |||
| to be mounted with a | |||
| superstructure having a post. | 8 mm | ||
| Diameter | NP: 4 mm | ||
| SP/WP: 4 mm, 5.7 mm | NP/SP/WP: 4 mm | NP: 4.0, 4.25, 4.8 mm | |
| SP: 4.25, 4.8, 5.8 mm | |||
| Sterilization | |||
| Method | Radiation | Radiation | Product provided non sterile and |
| end-user sterilized. |
6
the abuthents in the predicate are only available in 4 min diameter, the propose ble in both 4 mm and 5.7 mm diameters. The reterence device (K 163349) is includes mants in the ariginally classed meadinate daring herse 2 indoxer anti natation annual and abuturanta horio 12 indover outi-natalis a Connection Call Concession Comments of Children
Performance testing (Fatigue testing) is included in this premarket notification to support the substantial
equivalence of the proposed devices to the predicate device.
7
6.2 Line extension to predicate MIS CONNECT Conical Connection Superstructures:
An overview of the similarities and differences between the proposed and predicate Superstructure devices is given in Tables 6.2a - 6.2e below. A discussion of the similarities and differences follows Table 6.2a - 6.2e.
| Table 6.2a: Comparison of the proposed device to the predicate device (Healing Caps) | |||
|---|---|---|---|
| Element | MIS CONNECT Healing Caps | ||
| Proposed device | MIS CONNECT Healing | ||
| Caps | |||
| K173326 | |||
| Primary Predicate Device | MIS V3 Healing Caps | ||
| K163349 | |||
| Reference Device | |||
| Pictorial | |||
| Representation | Image: Proposed device | Image: Primary Predicate Device | Image: Reference Device |
| Material(s) | TI 6Al-4V ELI per ASTM F136. | TI 6Al-4V ELI per ASTM F136. | TI 6Al-4V ELI per ASTM F136. |
| Surface | |||
| Treatment | Anodized after machining | Anodized after machining | Polished and anodized after |
| machining | |||
| Connection | |||
| interface | Compatible with MIS | ||
| CONNECT abutment | Compatible with MIS | ||
| CONNECT abutment | Compatible with MIS Conical | ||
| Connection implants | |||
| Type of | |||
| Connection to | |||
| the MIS | |||
| CONNECT | |||
| abutment | Internal connection | ||
| Without indexes | Internal connection | ||
| Without indexes | NA - connects directly to the | ||
| implant in an internal connection | |||
| without indexes | |||
| Gingival | |||
| Height | Ø4: 0.5, 1.5, 3 mm | ||
| Ø5.7: 0.5, 1.5, 3 mm | Ø4: 0.5, 1.5 mm | 2, 3, 4, 5, 6, 8 mm | |
| Post Height | NA - the device is not intended | ||
| to serve as a basis for prosthetic | |||
| reconstruction | NA - the device is not intended | ||
| to serve as a basis for prosthetic | |||
| reconstruction | NA - the device is not intended to | ||
| serve as a basis for prosthetic | |||
| reconstruction | |||
| Diameter | 4mm, 5.7 mm | 4 mm | 3.3-5.8 mm |
| Sterilization | |||
| Method | Radiation | Radiation | Radiation |
8
Table 6.2b: Comparison of the proposed device to the predicate device (Temporary Abutment Superstructure)
| Element | MIS CONNECT Temporary
abutments
Proposed Device | MIS CONNECT Temporary
abutments
K173326
Primary Predicate Device | MIS V3 Temporary abutments
K163349
Reference Device |
|------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------|
| Pictorial
Representation | Image: MIS CONNECT Temporary abutments | Image: MIS CONNECT Temporary abutments K173326 | Image: MIS V3 Temporary abutments K163349 |
| Material(s) | Abutment: | Abutment: | Abutment: |
| | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 |
| | Prosthetic screw:
Ti 6Al 4V ELI per ASTM F136 | Prosthetic screw:
Ti 6Al 4V ELI per ASTM F136 | Prosthetic screw:
Ti 6Al 4V ELI per ASTM F136 |
| Connection
interface | Compatible with MIS
CONNECT abutment | Compatible with MIS
CONNECT abutment | Compatible with MIS Conical
Connection implants |
| Type of
Connection to
the MIS
CONNECT
abutment | Anti-rotation: regular hexagon
Free-rotation: no hexagon | Anti-rotation: irregular hexagon
Free-rotation: no hexagon | NA - Connects directly to the
implant |
| Gingival
Height | N/A - connects to the MIS
CONNECT abutment | N/A – connects to the MIS
CONNECT abutment | 1, 2, 3 mm |
| Post Height | 10 mm | 10 mm | 10, 10.5mm |
| Diameter | 4mm, 5.7 mm | 4 mm | 4.0, 4.8, 5.8 mm |
| Sterilization | Product provided non-sterile and
end-user sterilized. | Product provided non-sterile and
end-user sterilized. | Product provided non-sterile and
end-user sterilized. |
9
| Table 6.2c: Comparison of the proposed device to the predicate device (Final Esthetic Abutment | |||
|---|---|---|---|
| Superstructure) | |||
| Element | MIS CONNECT Final Esthetic | ||
| Abutments | |||
| Proposed device | MIS CONNECT Cementing | ||
| Cap Abutments | |||
| K173326 | |||
| Primary Predicate Device | MIS V3 Cement Retained | ||
| Abutments | |||
| K163349 | |||
| Reference Device | |||
| Pictorial | |||
| Representation | Image: MIS CONNECT Final Esthetic Abutments | Image: MIS CONNECT Cementing Cap Abutments | Image: MIS V3 Cement Retained Abutments |
| Material(s) | Abutment: | ||
| Ti-6Al-4V ELI per ASTM F136 |
Prosthetic screw:
Ti 6Al 4V ELI per ASTM F136 | Abutment:
Ti-6Al-4V ELI per ASTM F136
Prosthetic screw:
Ti 6Al 4V ELI per ASTM F136 | Abutment:
Ti-6Al-4V ELI per ASTM F136
Prosthetic screw:
Ti 6Al 4V ELI per ASTM F136 |
| Connection
interface | Compatible with MIS
CONNECT abutment | Compatible with MIS
CONNECT abutment | Compatible with MIS Conical
Connection implants |
| Type of
Connection to
the MIS
CONNECT
abutment | Anti-rotation: regular hexagon
Free-rotation: no hexagon | Anti-rotation: irregular hexagon
Free-rotation: no hexagon | NA - Connects directly to the
implant |
| Gingival
Height | N/A - connects to the MIS
CONNECT abutment | N/A – connects to the MIS
CONNECT abutment | 0.5, 1, 1.5, 2, 3 mm |
| Post Height | 6.05 mm | 6.05 mm | 5.95 mm |
| Diameter | 4mm, 5.7 mm | 4 mm | NP: 4.0, 4.25, 4.8 mm
SP: 4.25, 4.8, 5.8 mm |
| Sterilization | Product provided non-sterile and
end-user sterilized. | Product provided non-sterile and
end-user sterilized. | Product provided non-sterile and
end-user sterilized. |
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Table 6.2d: Comparison of the proposed device to the predicate device (Final Abutment Superstructure)
| Element | MIS CONNECT Final
Abutments
Proposed Device | MIS CONNECT Cementing
Cap Abutments
K173326
Primary Predicate Device | MIS V3 Cement Retained
Abutments
K163349
Reference Device |
|--------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Pictorial
Representation | Image: MIS CONNECT Final Abutments | Image: MIS CONNECT Cementing Cap Abutments | Image: MIS V3 Cement Retained Abutments |
| Material(s) | Abutment:
Ti-6Al-4V ELI per ASTM F136 | Abutment:
Ti-6Al-4V ELI per ASTM F136 | Abutment:
Ti-6Al-4V ELI per ASTM F136 |
| | Prosthetic screw:
Ti 6Al 4V ELI per ASTM F136 | Prosthetic screw:
Ti 6Al 4V ELI per ASTM F136 | Prosthetic screw:
Ti 6Al 4V ELI per ASTM F136 |
| Connection
interface | Compatible with MIS
CONNECT abutment | Compatible with MIS
CONNECT abutment | Compatible with MIS Conical
Connection implants |
| Type of
Connection to
the
CONNECT
abutment | Anti-rotation: regular hexagon
Free-rotation: no hexagon | Anti-rotation: irregular hexagon
Free-rotation: no hexagon | NA - Connects directly to the
implant |
| Gingival
Height | N/A - connects to the MIS
CONNECT abutment | N/A - connects to the MIS
CONNECT abutment | 0.5, 1, 1.5 ,2 ,3 mm |
| Post Height | For Ø4: 8 mm
For Ø5.7: 4 mm | 6 mm | 5.95 mm |
| Diameter | 4mm, 5.7mm | 4 mm | NP: 4.0, 4.25, 4.8 mm
SP: 4.25, 4.8, 5.8 mm |
| Sterilization | Product provided non-sterile and
end-user sterilized. | Product provided non-sterile and
end-user sterilized. | Product provided non-sterile and
end-user sterilized. |
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Table 6.2e: Comparison of the proposed device to the reference device (Angulated Abutment Superstructure)
| Element | MIS CONNECT
Ø4 Angulated Abutments | MIS C1 Conical Connection Cement Retained
Abutment
K172505 |
|------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------|
| | Proposed Device | Reference Device |
| Pictorial Representation | Image: MIS CONNECT Ø4 Angulated Abutment | Image: MIS C1 Conical Connection Cement Retained Abutment |
| Material(s) | Abutment: | Abutment: |
| | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 |
| | | |
| | Prosthetic screw: | Prosthetic screw: |
| | Ti 6Al 4V ELI per ASTM F136 | Ti 6Al 4V ELI per ASTM F136 |
| Surface Treatment | Polished and anodized after machining | Polished and anodized after machining |
| Connection interface | Connects to an MIS CONNECT abutment | Connects directly to the implant |
| Type of Connection to
the MIS CONNECT
abutment | Anti-rotation: regular hexagon
No free-rotation is available | NA - connects directly to the implant |
| Platform | Connects to MIS CONNECT Ø4 abutment | Connects directly to NP conical connection implants |
| Gingival Height | N/A - connects to MIS CONNECT abutment | 0.5, 1, 1.5, 2, 3 mm |
| Post Height | 6 mm / 7 mm
(Dependent on gingival collar thickness) | 6 mm / 7 mm
(Dependent on gingival collar thickness) |
| Diameter | 4 mm | NP: 4.0, 4.2, 4.25, 4.8 mm |
| Abutment angulation | 20° | NP: 0°, 10°, 20° |
| Sterilization Method | Product provided non sterile | Product provided non sterile |
The proposed MIS CONNECT Conical Connection Superstructures are substantially equivalent to the predicate device with respect to indications for use, principles of operation, and materials of construction.
The proposed and predicate devices have identical indications for use, are made of titanium alloy, and are intended for prosthetic restoration of maxillary and mandible.
While the Abutment Superstructures in the predicate device are only compatible with 4 mm diameter abutments (platform diameter), the proposed Abutment Superstructures are compatible with either 4 mm or 5.7 mm diameter abutments. The reference device (K163349) is included in support of substantital equivalence as it includes abutment superstructures with maximum 5.8 mm platform diameter.
12
While the predicate abutment superstructures connected to the MIS CONNECT Conical Connection Abutment via 3 indexes of anti-rotation, the proposed abutment superstructures connect to the MIS CONNECT Conical Connection Abutment via 12 indexes of anti-rotation in order to enhance rotational precision. The increased number of rotational indexes does not impact substantial equivalence as the modification does not affect abutment wall thickness and therefore does not present a new worst case with respect to connection geometry.
The proposed angulated abutment supersructures are offered with a 20° angulation. Reference device K172505 is included in support of substantial equivalence as it is offered in angulations up to 20°.
7.0 Non-Clinical Performance Data
Non-clinical testing data submitted, referenced. or relied upon to demonstrate substantial equivalence includes:
- . Fatigue testing: Dynamic fatigue testing of worst case representative samples of the proposed MIS CONNECT Conical Connection Abutments (line extension to the predicate) and superstructures was performed in accordance to ISO 14801:2016 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants. The results of the fatgue testing support substantial equivalence.
- Biocompatibility: The proposed devices are composed of the identical materials and are ● manufactured in the identical manufacturing facility and under the identical manufacturing processes as the primary predicate device (K173326). In addition, the intended conditions of use and patient contact type and duration of contact (as per ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) for the proposed devices are identical to that of the primary predicate device (K173326). Therefore, no new biocompatibility data are included in support of substantial equivalence.
- Sterilization: Sterilization validation of sterile devices was conducted for worst-case construct . according to ISO 11137-2:2013, Sterilization of health care products- Radiation- Part 2: Establishing the sterilization dose. The results of the sterilization support a conclusion that a sterility assurance level (SAL) of 10% is achieved under the sterilization parameters utilized.
Sterilization validation of non-sterile devices was conducted for worst-case construct according to ANSI/AAMI/ISO 17665-1:2006/(R)2013, Sterilization of health care products - Moist Heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. The results of the sterilization support a conclusion that a sterility assurance level (SAL) of 106 is achieved under the sterilization parameters utilized by the enduser.
- Packaging and packaging materials are the identical for the predicate and proposed devices. Thus, ● shelf life data are referenced by equivalence to support substantial equivalence.
8.0 Clinical Performance Data
No human clinical data were included in this premarket notification to support the substantial equivalence of the proposed line extension to predicate MIS CONNECT Connection Abutments.
13
- 9.0 Conclusion Regarding Substantial Equivalence
The proposed line extension to predicate MIS CONNECT Conical Connection Abutments are endosseus abutments and abutment superstructures which are intended to be used by dental clinicians for prosthetic restoration in the maxilla and mandible. The proposed devices incorporate the identical fundamental technology and intended use as the predicate MIS CONNECT Conical Connection Abutments and Superstructures device (K173326) and are proposed for identical indications for use. The identical materials of construction (Titanium alloy) and manufacturing processes are used to manufacture the proposed and predicate devices. Fatigue testing of the proposed device is included and the results support substantial equivalence.
The proposed angulated abutment superstructures are similar in design to the reference device MIS C1 Conical Connection Cement Retained Abutment (K172505). The proposed MIS CONNECT angulated abutment's angulation and diameter is within range of design offerings of the reference device (K172505).
The increased abutment diameter to 5.7 mm for the propsoed abutment superstructures is within range of the reference device MIS Cement Retained Abutments and Superstructures (K163349).
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 proposed MIS CONNECT Conical Connection Abutments and Superstructures to the predicate devices.