MIS Ti-base Abutment

K191152 · Dentsply Sirona · NHA · Jul 6, 2020 · Dental

Device Facts

Record IDK191152
Device NameMIS Ti-base Abutment
ApplicantDentsply Sirona
Product CodeNHA · Dental
Decision DateJul 6, 2020
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3630
Device ClassClass 2
AttributesTherapeutic

Intended Use

MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations. It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two-piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function. Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. MIS short implants are to be used only with straight abutments. Mesostructures for use with the MIS Ti-base abutment are to be made from inCoris ZI, designed and manufactured using Sirona CEREC SW version 4.6.1 Software. MIS Ti-base abutments are intended for use with the following MIS implants: C1 conical connection implant system. V3 conical connection implant system. SEVEN internal hex implant system. M4 internal hex implant system and Lance+ internal hex implant system.

Device Story

Device is a two-piece dental abutment system comprising a titanium base (Ti-base) and a CAD/CAM-fabricated zirconia mesostructure. The Ti-base connects to specific MIS dental implants via conical or internal hex connections. The mesostructure is designed using Sirona CEREC SW 4.6.1 software and cemented to the Ti-base using dental cement. The assembly is secured to the implant with a prosthetic screw. Used by dental professionals in clinical settings to support single or multiple-unit restorations. The software enforces design constraints (max 20° angulation, 0.5mm wall thickness) to ensure structural integrity. The device restores masticatory function and aesthetics for patients with missing teeth.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing: dynamic fatigue testing (ISO 14801:2016) showing survival of 2,000,000 cycles without failure, and sterilization validation (ANSI/AAMI/ISO 17665-1/2).

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136) for Ti-base and screw; InCoris ZI zirconium oxide for mesostructure. Connection: Conical or internal hex. Dimensions: 0.5-3.0mm gingival heights, 4.0mm post height. Connectivity: Encrypted design library for CAD/CAM integration. Sterilization: Non-sterile, user-steam-sterilizable.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit cement or screw-retained restorations on MIS dental implants to restore masticatory function and aesthetics. Narrow platform bases restricted to mandibular central/lateral incisors and maxillary lateral incisors. Short implants restricted to straight abutments.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 6, 2020 Dentsply Sirona Karl Nittinger Director, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401 Re: K191152 Trade/Device Name: MIS Ti-base Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA. PNP Dated: June 11, 2020 Received: June 11, 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. 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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 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) K191152 Device Name MIS Ti-Base Abutment Indications for Use (Describe) MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cementretained or screw retained single or multiple-unit restorations. It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two-piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function. Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. MIS short implants are to be used only with straight abutments. Mesostructures for use with the MIS Ti-base abutment are to be made from inCoris ZI, designed and manufactured using Sirona CEREC SW version 4.6.1 Software. MIS Ti-base abutments are intended for use with the following MIS implants: C1 conical connection implant system. V3 conical connection implant system. SEVEN internal hex implant system. M4 internal hex implant system and Lance+ internal hex implant system. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 Image /page/3/Picture/2 description: The image shows the Dentsply Sirona logo. The logo consists of a stylized, abstract shape on the left, resembling a curved or folded form. To the right of the shape are the words "Dentsply" stacked on top of "Sirona", both in a simple, sans-serif font. The overall design is clean and corporate, suggesting a professional and modern company. # 510(k) SUMMARY for MIS Ti-base abutment #### 1. Submitter: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 Karl Nittinger Contact Person: Telephone Number: 717-849-4424 Fax Number: 717-849-4343 Date Prepared: July 2, 2020 ### 2. Device Name: - Trade/Proprietary Name: MIS Ti-base abutment ● - . Common/Usual Name: Dental abutment - Classification Name: Endosseous dental implant abutment PNP - . Regulation Number: 872.3630 - Product Code: NHA - Secondary Product Code: - Device Class: Class II - . Dental Devices Panel Classification Panel: ### 3. Predicate Device(s): Primary predicate device: - Sirona Dental CAD/CAM System (K181520). ● Reference devices: - Sirona Dental CAD/CAM System (K111421) ● - MIS Dental Implant System (K192149) - . MIS V3 Conical Connection Dental Implant System (K163349) - MIS Conical Connection Implants (K112162) - MIS Internal Hex Dental Implant System (K180282) - MIS C1 narrow platform implants cleared under (K172505) - MIS Short Implants (K103089) {4}------------------------------------------------ # 4. Device Description: The subject MIS Ti-base abutments are endosseous dental implant abutments intended to be connected to MIS dental implants and used to support CAD/CAM customized cement-retained or screw retained single or multiple-unit restorations. MIS Ti-base abutments consist of a titanium base and a prosthetic screw, both made of TI-6AI-4V ELI complying with ASTM F136. The prosthetic screw tightens the finished CAD/CAM abutment to the dental implant. MIS Ti-base abutments are the bottom-half/base of a two-piece custom zirconia-titanium abutment consisting of a zirconium coping/mesostructure and a titanium base. The top-half custom zirconia coping/mesostructure or crown is intended to be fabricated from Sirona inCoris ZI zirconium oxide ceramic block and designed and milled using Sirona chairside Dental CAD/CAM System, with software version: CEREC SW version 4.6.1. The mesostructure design will be subject to the Sirona system controls, such as: A maximum angulation of 20° and minimum wall thickness of 0.5mm. The InCoris Zi mesostructure is to be cemented to the subject MIS Ti-base abutments using PANAVIA F 2.0 dental cement in order to complete the two-piece, CAD/CAM abutment. lt is not permitted to reduce the Ti-base's diameter, shorten the Ti-base or modify its implant-abutment connection and emergence profile in any way. The subject pre-fabricated titanium base abutment is designed with interface compatibility to specific MIS dental implant systems. The subject MIS Ti-base abutments are MIS conical connection and internal hex connection Ti-base abutments, and their connection is compatible with MIS conical connection C1 and V3 implants, and MIS SEVEN, M4 and Lance+ internal hex implants, which are not subject to this submission and were previously cleared. # 5. Indications for Use: MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations. It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a twopiece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function. Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. MIS short implants are to be used only with straight abutments. Mesostructures for use with the MIS Ti-base abutment are to be made from inCoris ZI, designed and manufactured using Sirona CEREC SW version 4.6.1 Software. MIS Ti-base abutments are intended for use with the following MIS implants: C1 conical connection implant system, V3 conical connection implant system, SEVEN internal hex implant system, M4 internal hex implant system and Lance+ internal hex implant system. {5}------------------------------------------------ # 6. Substantial Equivalence Discussion: The subject MIS Ti-base abutments have the same intended use as the predicate Sirona Ti-bases cleared under K181520. They are intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations, in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The primary differences between the subject and predicate Ti-bases are minor geometrical differences. Both subject and predicate Ti-bases are indicated for use with an inCoris mesostructure designed and milled with Sirona Dental CAD/CAM System. The subject MIS Ti-base abutments are indicated for use with MIS dental implants while the predicate Ti-bases are indicated for use with different implant systems. The principal of operation of the predicate and subject Ti-bases is the same. The digitally designed mesostructure is cemented to the Ti-base to make up a two-piece abutment. This two-piece abutment is attached to the implant by a prosthetic screw. Table 1 provides a summary comparison of the indications for use and technological characteristics of the subject MIS Ti-base Abutments and the predicate Sirona TiBases cleared under K181520. Table 1a. follows Table 1 and is provided as a summary comparison of the indications for use of the subject MIS Ti-base Abutments and the reference devices identified in Section 3 of this 510(k) Summary. The identified reference devices are used to document the subject MIS Ti-base Abutments' implant system compatibility. The indications for use comparison summary in Table 1a. demonstrates that relevant restrictions which are part of the cleared indications for use of the reference device implant systems (i.e., "MIS short implants are to be used only with straight abutments") are also included in the indications for use of the subject MIS Ti-Base Abutments. However, dental implant-specific indications in the cleared indications for use statements of the implant system reference devices are not applicable to the subject MIS Ti-base Abutments. The K111421 reference device (Sirona Dental CAD/CAM System) is included due to the fact the fatigue test data originally submitted in K111421 was utilized as a comparator to the fatigue test results of the worst case constructs tested in support of the substantial equivalence of the subject MIS Ti-base Abutments in this premarket notification. Table 1 – Comparison of MIS Ti-base abutment Characteristics {6}------------------------------------------------ | Trade Name | MIS Ti-base Abutments | Sirona Dental CAD/CAM System | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Subject | K181520 | | Manufacturer | MIS Implants Technologies Ltd. | Dentsply Sirona | | Device Class | Class II | Class II | | Product Code(s) | NHA | NHA | | Regulation<br>Description | Endosseous dental implant abutment | Endosseous dental implant abutment | | Regulation Number | 872.3630 | 872.3630 | | Indications for use: | MIS Ti-base abutments are intended for use in partially<br>or fully edentulous mandibles and maxillae in support<br>of single or multiple-unit cement retained restorations,<br>in conjunction with endosseous dental implants to<br>restore the function and aesthetics in the oral cavity. | The Sirona Dental CAD/CAM System is intended for use in partially or fully<br>edentulous mandibles and maxillae in support of single or multiple-unit<br>cement retained restorations, in conjunction with endosseous dental implants<br>to restore the function and aesthetics in the oral cavity. | | | MIS Ti-base abutment is a titanium base placed onto<br>MIS dental implants to provide support for customized<br>cement-retained or screw retained single or multiple-<br>unit restorations.<br>It is used with a digitally designed mesostructure. MIS<br>Ti-base and the mesostructure make up a two-piece<br>abutment used in conjunction with MIS dental<br>implants, to be placed in the upper or lower jaw arches,<br>in order to restore masticatory function.<br>Narrow platform Ti-bases are indicated for use only in<br>the mandibular central, lateral incisor and maxillary<br>lateral incisor regions of partially edentulous jaws.<br>MIS short implants are to be used only with straight<br>abutments.<br>Mesostructures for use with the MIS Ti-base abutment<br>are to be made from inCoris ZI, designed and<br>manufactured using Sirona CEREC SW version 4.6.1<br>Software. | The Sirona Dental CAD/CAM System is intended for use in partially or fully<br>edentulous mandibles and maxillae in support of single or multiple-unit<br>cement retained restorations. For the BH 3.0 S, SSO 3.5 L and SBL 3.3 L<br>titanium bases, the indication is restricted to the replacement of single lateral<br>incisors in the maxilla and lateral and central incisors in the mandible. The<br>system consists of three major parts: TiBase, inCoris mesostructure, and<br>CAD/CAM software. Specifically, the inCoris mesostructure and TiBase<br>components make up a two-piece abutment which is used in conjunction with<br>endosseous dental implants to restore the function and aesthetics in the oral<br>cavity. The inCoris mesostructures may also be used in conjunction with the<br>Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog<br>Implant System. The CAD/CAM software is intended to design and fabricate<br>the inCoris mesostructure. | {7}------------------------------------------------ MIS Ti-base abutments are intended for use with the following MIS implants: C1 conical connection implant system, V3 conical connection implant system, SEVEN internal hex implant system, M4 internal hex implant system and Lance+ internal hex implant system. | Manufacturer | Name of<br>Implant<br>System | Implant Size<br>Platform | Diameter | |-----------------------------------------|-------------------------------------------------------------|--------------------------|---------------------| | Nobel Biocare | Replace | NP | 3.5 | | | | RP | 4.3 | | | | WP | 5.0 | | | | 6.0 | 6.0 | | | Active | NP | 3.5 | | | | RP | 4.3/5.0 | | | Branemark | NP | 3.3 | | | | RP | 3.75/4.0 | | Straumann | Synocta | NN (3.5mm) | 3.3 | | | | RN (4.8mm) | 3.3/4.1/4.8 | | | | WN (6.5mm) | 4.8 | | | Bone Level | NC (3.3mm) | 3.3 | | | | RC(4.1mm/4.8mm | 4.1/4.8 | | Dentsply Sirona<br>Implants | Osseospeed | 3.5/4.0 | 3.5 S / 4.0 S | | | | 4.5/5.0 | 4.5/5.0/5.0 S | | | Xive | 3.4 | 3.4 | | | | 3.8 | 3.8 | | | | 4.5 | 4.5 | | | | 5.5 | 5.5 | | | Osseospeed | 3.6 | 3.6 | | | | 4.2 | 4.2 | | | EV | 4.8 | 4.8 | | | | 5.4 | 5.4 | | | Ankylos | C/X | A, B, C, D | | Biomet 3i | Osseotite | 3.4 | 3.25 | | | | 4.1 | 3.75 | | | | | 4.1 | | | | 5.0 | 3/4 | | | | | 5.0 | | | | | 4/5 | | | Certain | 3.4 | 3.25 | | | | | 4/3 | | | | | | | | | | 3/4/3 | | | | 4.1 | 4.0 | | | | | 4/5/4 | | | | | 5/4 | | | | 5.0 | 5.0 | | | | | 4/5 | | Zimmer | Tapered<br>Screw-Vent | 3.5 | 3.7/4.1 | | | | 4.5 | 4.7 | | | | 5.7 | 6 | | Thommen<br>Medical | SPI<br>ELEMENT, | 3.5 | 3.5 | | | SPI<br>ELEMENT | 4 | 4 | | | SPI<br>ELEMENT | 4.5 | 4.5 | | | SPI<br>ELEMENT | 5 | 5 | | | INICELL, SPI<br>CONTACT<br>INICELL | 6 | 6 | | Osstem/Hiossen | Osstem TS<br>Implant<br>System | Mini | 3.5 | | | Hiossen<br>Implant<br>System | Regular | 4.0/4.5/5.0/6.0/7.0 | | BioHorizons<br>(Internal<br>Connection) | Tapered<br>3.0,Tapered<br>plus | 3.0 | 3.0/3.4/3.8 | | | Tapered<br>internal | | 3.0 | | | Tapered<br>plus | | 4.6 | | | Tapered<br>internal,<br>Tapered<br>internal<br>tissue level | 3.5 | 3.0/3.8 | | | Internal<br>dental<br>implant | | 3.5 | {8}------------------------------------------------ {9}------------------------------------------------ | Ti-base Material | Abutment and Abutment screw Ti 6Al 4V ELI per ASTM F136 | | |------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Single stage<br>dental<br>implants 3.5/4.0 | | | | Tapered Plus 5.8 | | | | Tapered internal,<br>Tapered internal<br>tissue level 4.6 | | | | 4.5 4.0 | | | | Internal dental<br>implant Single stage<br>dental implants 4.0/5.0 | | | | Tapered internal,<br>Tapered internal<br>tissue level 5.8 | | | | Internal dental<br>implant, Single stage<br>dental implants 5.7 5.0/6.0 | | Implant to abutment<br>Connection | Conical connection Internal hex connection | Indexed Conical taper, non-indexed conical taper External Hex., Internal Hex. External Octagonal, Internal Octagonal Internal 3-tenon Internal 4-slotted External 6-position indexed | | Anti-rotation/free-<br>rotation (Abutment/<br>Implant Interface) | Conical connection: both options Internal hex connection: both options | Both options. | | Restoration | Single-unit<br>Multiple-unit | Single-unit<br>Multiple-unit | | Prosthesis<br>Attachment | Cement-retained<br>Screw-retained | Cement-retained<br>Screw-retained | | Platforms | NP 3.3<br>SP 3.75, 3.9, 4.2, 4.3, 5.0<br>WP 5.0, 6.0 | As listed in predicate indications for use statement. | | Gingiva Height | NP: 0.5, 1.5 mm<br>SP: 0.5, 1.5, 3.0 mm<br>WP: 0.5, 1.5, 3.0 mm | 0.5 mm – 1.6 mm | | Post Height | 4.0 mm | 4.675 mm | | Compatible implant<br>system | MIS C1 Conical Connection MIS V3 Conical Connection SEVEN Internal Hex | As listed in the predicate indications for use statement. | | Compatible implant<br>diameter (mm) | C1/V3 NP: 3.3<br>SEVEN NP: 3.3<br>C1 SP: 3.75, 4.2<br>V3 SP: 3.9, 4.3, 5.0<br>C1 WP: 5.0<br>SEVEN SP: 3.75, 4.2<br>SEVEN WP: 5.0, 6.0<br>M4<br>Lance+ | 3.0 mm – 7.0 mm | | Finished CAD/CAM<br>Abutment<br>Angulation | 0° - 20° | 0° - 20° | | Two-piece Abutment<br>Mesostructure<br>Material | InCoris ZI zirconium oxide | InCoris ZI zirconium oxide | | Sterilization Method | Product provided non sterile | Product provided non sterile | | Sterilization by<br>end user | Moist steam sterilization | Moist steam sterilization | {10}------------------------------------------------ {11}------------------------------------------------ | MIS Ti-base Abutments<br>Subject Device | Sirona Dental CAD/CAM System<br>Reference Device<br>(K111421) | MIS Dental Implant System<br>Reference Device<br>(K192149) | MIS V3 Conical Connection Dental<br>Implant System<br>Reference Device<br>(K163349) | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | MIS Ti-base abutments are intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations, in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity.<br>MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations.<br>It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two-piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function.<br>Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.<br>MIS short implants are to be used only with straight abutments.<br>Mesostructures for use with the MIS Ti-base abutment are to be made from inCoris ZI, designed and manufactured using Sirona CEREC SW version 4.6.1 Software.<br>MIS Ti-base abutments are intended for use with the following MIS implants:<br>C1 conical connection implant system, V3 conical connection implant system, SEVEN internal hex implant system, M4 internal hex implant system and Lance+ internal hex implant system. | The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the SSO 3.5 L and SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system consists of three major parts: TiBase, inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructures may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems:<br>• Nobel Biocare Replace (K020646)<br>• Nobel Biocare Branemark (K022562)<br>• Friadent Xive (K013867)<br>• Biomet 3i (Osseotite)<br>• Astra Tech Osseospeed (K091239)<br>• Zimmer Tapered Screw-Vent (K061410)<br>• Straumann SynOcta (K061176)<br>• Straumann Bone Level (K053088, K062129, K060958)<br>• Biomet 3i Certain (K014235, K061629) | 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.<br>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.<br>MIS short implants are to be used only with straight abutments. | MIS V3 Conical Connection Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function.<br>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.<br>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. | ## Table 1a. – Comparison of Proposed MIS Ti-bases Abutments & Reference Devices Indications for Use. {12}------------------------------------------------ | MIS Ti-base Abutments<br>Subject Device | MIS Conical Connection Implants<br>Reference Device<br>(K112162) | MIS Internal Hex Dental Implant System<br>Reference Device<br>(K180282) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | MIS Ti-base abutments are intended for use in partially or<br>fully edentulous mandibles and maxillae in support of<br>single or multiple-unit cement retained restorations, in<br>conjunction with endosseous dental implants to restore<br>the function and aesthetics in the oral cavity.<br><br>MIS Ti-base abutment is a titanium base placed onto MIS<br>dental implants to provide support for customized<br>cement-retained or screw retained single or multiple-unit<br>restorations.<br><br>It is used with a digitally designed mesostructure. MIS Ti-<br>base and the mesostructure make up a two-piece<br>abutment used in conjunction with MIS dental implants,<br>to be placed in the upper or lower jaw arches, in order to<br>restore masticatory function.<br><br>Narrow platform Ti-bases are indicated for use only in the<br>mandibular central, lateral incisor and maxillary lateral<br>incisor regions of partially edentulous jaws.<br><br>MIS short implants are to be used only with straight<br>abutments.<br><br>Mesostructures for use with the MIS Ti-base abutment are<br>to be made from inCoris ZI, designed and manufactured<br>using Sirona CEREC SW version 4.6.1 Software.<br><br>MIS Ti-base abutments are intended for use with the<br>following MIS implants:<br>C1 conical connection implant system, V3 conical<br>connection implant system, SEVEN internal hex implant<br>system, M4 internal hex implant system and Lance+<br>internal hex implant system. | MIS Conical Connection Implants are intended<br>to be surgically placed<br>in the bone of the upper or lower jaw arches toprosthetic devices, such as artificial teeth, in<br>order to restore a patient's<br>chewing function.<br><br>When a one stage surgical procedure is applied,<br>the implant may be<br>immediately loaded when good primary<br>stability is achieved and the<br>occlusal load is appropriate. | MIS dental implant systems are intended to<br>be surgically placed in the bone of the<br>upper or lower jaw arches to provide<br>support for prosthetic devices, such as<br>artificial teeth, in order to restore<br>masticatory function. When a one-stage<br>surgical<br>procedure is applied, the implant may be<br>immediately loaded when good primary<br>stability is achieved and the occlusal<br>load is appropriate.<br><br>Narrow implants (Ø3.3mm & UNO) are<br>indicated for use in surgical and restorative<br>applications for placement only in the<br>mandibular central, lateral incisor and<br>maxillary lateral incisor regions of partially<br>edentulous jaws, to provide support for<br>prosthetic devices such as artificial teeth.<br>Mandibular central and lateral incisors must<br>be splinted if using two or more<br>narrow implants adjacent to one another.<br>The long MIS (18 & 20 mm) implants can be<br>used in a tilted manner.<br>MIS short implants are to be used only with<br>straight abutments.<br>M4 short implants are indicated for delayed<br>loading only. | #### Table 1a. (continued) – Comparison of Proposed MIS Ti-bases Abutments & Reference Devices Indications for Use. {13}------------------------------------------------ | MIS Ti-base Abutments<br>Subject Device | MIS C1 Narrow Platform Implants<br>Reference Device<br>(K172505) | MIS Short Implants<br>Reference Device<br>(K103089) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | MIS Ti-base abutments are intended for use in partially or<br>fully edentulous mandibles and maxillae in support of<br>single or multiple-unit cement retained restorations, in<br>conjunction with endosseous dental implants to restore<br>the function and aesthetics in the oral cavity.<br>MIS Ti-base abutment is a titanium base placed onto MIS<br>dental implants to provide support for customized<br>cement-retained or screw retained single or multiple-unit<br>restorations.<br>It is used with a digitally designed mesostructure. MIS Ti-<br>base and the mesostructure make up a two-piece<br>abutment used in conjunction with MIS dental implants,<br>t…
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