(432 days)
No
The summary describes a dental implant abutment and its use with a CAD/CAM system for designing mesostructures. While CAD/CAM systems involve software, there is no mention of AI or ML being used in the design or manufacturing process of the abutment or the mesostructure. The software validation focuses on design limitations and compatibility, not AI/ML capabilities.
Yes.
This device, a titanium base abutment for dental implants, is used to restore masticatory function, which is a therapeutic purpose.
No
The device is an abutment for dental implants, providing support for restorations and restoring masticatory function. It is a restorative component, not a diagnostic tool.
No
The device described is a physical dental abutment made of titanium. While it is used in conjunction with CAD/CAM software for designing the mesostructure, the device itself is a hardware component. The software mentioned (Sirona CEREC SW) is used to design a separate part (the mesostructure) that attaches to the titanium base. The 510(k) submission focuses on the physical properties and performance of the titanium abutment.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant abutment used to support dental restorations and restore masticatory function. This is a mechanical and structural function within the body.
- Device Description: The description details the physical components of the abutment (titanium base, screw) and how it connects to dental implants and supports a mesostructure. It describes a physical device for implantation and support.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease. IVDs are used for diagnostic purposes, not for structural support or restoration.
The device is a medical device, specifically a dental implant component, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA, PNP
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.
It 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.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance tests were conducted.
- Biocompatibility: Not required as the device uses identical manufacturing methods, facility, and raw materials as previously cleared reference device K163349, and has the same patient contact duration and type. The InCoris ZI material for the mesostructure is also cleared under K181520, so no new data was needed.
- Fatigue Testing: Mechanical testing in accordance with ISO 14801:2016 was performed on the narrowest abutments from both narrow and standard platforms with a 20° mesostructure. Test articles withstood 2,000,000 cycles without failure at a load equivalent to cited predicates. Results support substantial equivalence.
- Sterilization Testing: Validation of steam sterilization parameters (gravity displacement and pre vacuum) according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for the non-sterile supplied device.
- Software verification and validation testing: Performed for the abutment design library to ensure proper use with CEREC SW version 4.6.1, demonstrating that design restrictions prevent mesostructure component design outside limitations and that the encrypted library's specifications are locked and unmodifiable.
No human clinical data was included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K111421, K192149, K163349, K112162, K180282, K172505, K103089
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 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.)
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)
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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 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 | ||
| 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 | |
| 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 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, in conjunction with endosseous dental implants | ||
| to restore the function and aesthetics in the oral cavity. | ||
| 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. | 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 BH 3.0 S, 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. |
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
Implant
System | Implant Size
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
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
Screw-Vent | 3.5 | 3.7/4.1 |
| | | 4.5 | 4.7 |
| | | 5.7 | 6 |
| Thommen
Medical | SPI
ELEMENT, | 3.5 | 3.5 |
| | SPI
ELEMENT | 4 | 4 |
| | SPI
ELEMENT | 4.5 | 4.5 |
| | SPI
ELEMENT | 5 | 5 |
| | INICELL, SPI
CONTACT
INICELL | 6 | 6 |
| Osstem/Hiossen | Osstem TS
Implant
System | Mini | 3.5 |
| | Hiossen
Implant
System | Regular | 4.0/4.5/5.0/6.0/7.0 |
| BioHorizons
(Internal
Connection) | Tapered
3.0,Tapered
plus | 3.0 | 3.0/3.4/3.8 |
| | Tapered
internal | | 3.0 |
| | Tapered
plus | | 4.6 |
| | Tapered
internal,
Tapered
internal
tissue level | 3.5 | 3.0/3.8 |
| | Internal
dental
implant | | 3.5 |
8
9
| Ti-base Material | Abutment and Abutment screw Ti 6Al 4V ELI per ASTM F136 | |
|---|---|---|
| Single stage | ||
| dental | ||
| implants 3.5/4.0 | ||
| Tapered Plus 5.8 | ||
| Tapered internal, | ||
| Tapered internal | ||
| tissue level 4.6 | ||
| 4.5 4.0 | ||
| Internal dental | ||
| implant Single stage | ||
| dental implants 4.0/5.0 | ||
| Tapered internal, | ||
| Tapered internal | ||
| tissue level 5.8 | ||
| Internal dental | ||
| implant, Single stage | ||
| dental implants 5.7 5.0/6.0 | ||
| Implant to abutment | ||
| 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- | ||
| rotation (Abutment/ | ||
| Implant Interface) | Conical connection: both options Internal hex connection: both options | Both options. |
| Restoration | Single-unit | |
| Multiple-unit | Single-unit | |
| Multiple-unit | ||
| Prosthesis | ||
| Attachment | Cement-retained | |
| Screw-retained | Cement-retained | |
| Screw-retained | ||
| Platforms | NP 3.3 | |
| SP 3.75, 3.9, 4.2, 4.3, 5.0 | ||
| WP 5.0, 6.0 | As listed in predicate indications for use statement. | |
| Gingiva Height | NP: 0.5, 1.5 mm | |
| SP: 0.5, 1.5, 3.0 mm | ||
| WP: 0.5, 1.5, 3.0 mm | 0.5 mm – 1.6 mm | |
| Post Height | 4.0 mm | 4.675 mm |
| Compatible implant | ||
| system | MIS C1 Conical Connection MIS V3 Conical Connection SEVEN Internal Hex | As listed in the predicate indications for use statement. |
| Compatible implant | ||
| diameter (mm) | C1/V3 NP: 3.3 | |
| SEVEN NP: 3.3 | ||
| C1 SP: 3.75, 4.2 | ||
| V3 SP: 3.9, 4.3, 5.0 | ||
| C1 WP: 5.0 | ||
| SEVEN SP: 3.75, 4.2 | ||
| SEVEN WP: 5.0, 6.0 | ||
| M4 | ||
| Lance+ | 3.0 mm – 7.0 mm | |
| Finished CAD/CAM | ||
| Abutment | ||
| Angulation | 0° - 20° | 0° - 20° |
| Two-piece Abutment | ||
| Mesostructure | ||
| Material | InCoris ZI zirconium oxide | InCoris ZI zirconium oxide |
| Sterilization Method | Product provided non sterile | Product provided non sterile |
| Sterilization by | ||
| end user | Moist steam sterilization | Moist steam sterilization |
10
11
| MIS Ti-base Abutments
Subject Device | Sirona Dental CAD/CAM System
Reference Device
(K111421) | MIS Dental Implant System
Reference Device
(K192149) | MIS V3 Conical Connection Dental
Implant System
Reference Device
(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.
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. | 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:
• Nobel Biocare Replace (K020646)
• Nobel Biocare Branemark (K022562)
• Friadent Xive (K013867)
• Biomet 3i (Osseotite)
• Astra Tech Osseospeed (K091239)
• Zimmer Tapered Screw-Vent (K061410)
• Straumann SynOcta (K061176)
• Straumann Bone Level (K053088, K062129, K060958)
• 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.
Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
MIS short implants are to be used only with straight abutments. | MIS 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.
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. |
Table 1a. – Comparison of Proposed MIS Ti-bases Abutments & Reference Devices Indications for Use.
12
| MIS Ti-base Abutments
Subject Device | MIS Conical Connection Implants
Reference Device
(K112162) | MIS Internal Hex Dental Implant System
Reference Device
(K180282) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
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. | MIS Conical Connection Implants are intended
to be surgically placed
in the bone of the upper or lower jaw arches toprosthetic devices, such as artificial teeth, in
order to restore a patient's
chewing 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. | MIS dental implant systems are intended to
be surgically placed in the bone of the
upper or lower jaw arches to provide
support for prosthetic devices, such as
artificial teeth, in order to restore
masticatory function. When a one-stage
surgical
procedure is applied, the implant may be
immediately loaded when good primary
stability is achieved and the occlusal
load is appropriate.
Narrow implants (Ø3.3mm & UNO) are
indicated for use in surgical and restorative
applications for placement only in the
mandibular central, lateral incisor and
maxillary lateral incisor 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. |
Table 1a. (continued) – Comparison of Proposed MIS Ti-bases Abutments & Reference Devices Indications for Use.
13
| MIS Ti-base Abutments
Subject Device | MIS C1 Narrow Platform Implants
Reference Device
(K172505) | MIS Short Implants
Reference Device
(K103089) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
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. | MIS 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.
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 & 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, 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 implants 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 a patient's chewing
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.
MIS short implants are to be used only with
straight abutments. |
Table 1a. (continued) – Comparison of Proposed MIS Ti-bases Abutments & Reference Devices Indications for Use.
14
7. Non-Clinical Performance Data:
As part of demonstrating the substantial equivalence of MIS T-base abutments to the predicate devices (K181520) listed in this 510(k) submission, MIS Implants Technologies completed a number of non-clinical performance tests:
- . Biocompatibility - The subject device is manufactured using identical manufacturing methods, in the same manufacturing facility, and using the same raw material as the previously cleared reference device, K163349. The subject device has the same patient contact duration and type as the identified reference device. For these reasons, biocompatibility testing was not required to support substantial equivalence of the subject device. Consideration of biocompatibility requirements was made with reference to Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
- . Biocompatibility (two-piece abutments mesostructure) — The final two-piece CAD/CAM abutments which are constructed utilizing the subject MIS Ti-base components are completed with CAM milled mesostructures composed of the InCoris ZI zirconium oxide material. The InCoris ZI meso material is cleared under K181520 and no modifications to the material are included in this premarket notification. Therefore, no new biocompatibility data relating to the InCoris ZI material was included in this submission in support of substantial equivalence.
- . Fatigue Testing – Mechanical testing of MIS Ti-base abutments in accordance to ISO 14801:2016 was conducted. The worst case abutments chosen for the tests were the narrowest abutments from both narrow and standard platforms, with a 20° mesostructure which is the maximum angulation possible in the Sirona Dental CAD/CAM System. The test articles were able to withstand 2,000,000 cycles without failure at a substantially equivalent load to the cited predicates. The fatigue test conducted on the standard platform worst case abutment supports the wide platform abutments as the SP is a worst case in terms of diameter and wall thickness, and both SP and WP abutments are made of the same material. The results of fatigue testing support substantial equivalence. Fatigue testing was conducted with reference to the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
- . Sterilization Testing – MIS Ti-base abutments are supplied non-sterile and intended to be steam sterilized by the user. The steam sterilization parameters were validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for two methods: gravity displacement steam sterilization and pre vacuum steam sterilization validation of the recommended sterilization process for the subject devices was conducted with reference to Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
- Reverse engineering analysis was not conducted in support of substantial equivalence due to the fact that the subject MIS Ti-base Abutments are proposed for compatibility only with MIS
15
dental implant systems. Dentsply Sirona is the sponsor/applicant of this premarket notification as the Owner/Operator of MIS Implants Technologies, Ltd.
- . Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the "chairside" CAD/CAM software, CEREC SW version 4.6.1. Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the mesostructure component outside of design limitations. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library.
8. Clinical Performance Data:
There was no human clinical data included in support of substantial equivalence. The non-clinical testing detailed in this submission support the substantial equivalence of the device.
9. Summary:
The comparison between the subject device and the predicate devices has shown that the indications for use, principles of operation, technological characteristics are the same. The results of nonclinical performance testing support a conclusion that the subject device is at least equivalent to the predicate devices with respect to dynamic fatigue performance.
10. Conclusion Regarding Substantial Equivalence:
The subject MIS Ti-base abutments have the same intended use, incorporate the same fundamental technology, and have similar indications for use as the predicate device (K181520). Test data to verify the performance of MIS Ti-base abutments has been provided including: dynamic fatigue and sterilization validation and the results of this testing, combined with the design and intended use comparison with the predicate device, support substantial equivalence.