MIS Angulated multi-unit abutments
Device Facts
| Record ID | K213432 |
|---|---|
| Device Name | MIS Angulated multi-unit abutments |
| Applicant | Dentsply Sirona |
| Product Code | NHA · Dental |
| Decision Date | Apr 1, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.30mm) 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 & 20mm) 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.
Device Story
MIS Angulated multi-unit abutments are endosseous dental implant components used to anchor screw-retained multiple-unit restorations. The system includes a one-piece abutment, a prosthetic multi-unit screw, and a titanium gripping bar for positioning. The device connects to MIS dental implants via conical or internal-hex connections. The cementing cap serves as a superstructure interface for permanent restorations. Used in dental clinics by trained professionals, the device provides a stable foundation for prosthetic teeth. By allowing for angulated placement (17° or 30°), the system enables clinicians to compensate for implant trajectory, facilitating optimal prosthetic alignment in patients with varying bone anatomy. This improves the feasibility of fixed restorations in complex cases, ultimately restoring masticatory function and aesthetics for the patient.
Clinical Evidence
No clinical data was included. Substantial equivalence is supported by bench testing, specifically dynamic fatigue testing per ISO 14801:2016, demonstrating the device withstands 5,000,000 cycles without failure. Sterilization validation (gamma irradiation for sterile components, moist heat for non-sterile components) and shelf-life testing (5-year claim) were also provided.
Technological Characteristics
Materials: Titanium (ASTM F136-13). Design: One-piece abutment with multi-unit screw; 17° and 30° angulations; Narrow, Standard, and Wide platforms. Connection: Conical or Internal-hex. Sterilization: Gamma irradiation (sterile components) or moist heat (non-sterile components). Connectivity: None (mechanical device).
Indications for Use
Indicated for surgical placement in upper or lower jaw bone to support prosthetic devices (artificial teeth) for masticatory function restoration. Narrow implants (Ø3.30mm) restricted to mandibular central/lateral incisors and maxillary lateral incisors in partially edentulous patients; requires splinting for adjacent narrow implants. Contraindicated for immediate loading of M4 short implants (delayed loading only) and use of short implants with angulated 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
- MIS V3 Conical Connection Dental Implant System (K163349)
Reference Devices
- MIS C1 Wide Platform Conical Connection Abutment (K172505)
- MIS Internal Hex Dental Implant System (K180282)
- Ankylos Balance Base Abutments (K122268)
Submission Summary (Full Text)
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Dentsply Sirona Courtney Clark Sr. Director of Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401
### Re: K213432
Trade/Device Name: MIS Angulated multi-unit abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 3, 2022 Received: March 4, 2022
#### Dear Courtney Clark:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
#### K213432
Device Name MIS Angulated multi-unit abutments
#### Indications for Use (Describe)
MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.
Narrow implants (Ø3.30mm) 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 & 20mm) implants can be used in a tilted manner. MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
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### 510(k) SUMMARY for MIS Angulated multi-unit abutments - K213432
#### 1. Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Primary Contact Person: Courtney Clark Telephone Number: 248-895-4379 Fax Number: 717-849-4343
Date Prepared: April 1, 2022
# 2. Device Name:
.
- Proprietary Name: ● MIS Angulated multi-unit abutments
- Classification Name: ● Endosseous dental implant abutment
- CFR Number: 872.3630
- Device Class: II
- Product Code: . NHA
- 3. Predicate Device:
The primary predicate and reference devices identified relating to the substantial equivalence for the MIS Angulated multi-unit abutments are:
| Primary Predicate Device Name | 510(k) | Company Name |
|-----------------------------------------------------|---------|-----------------------------------------------------|
| MIS V3 Conical Connection<br>Dental Implant System | K163349 | MIS Implants Technologies Ltd.<br>(Dentsply Sirona) |
| Reference Device Name | 510(k) | Company Name |
| MIS C1 Wide Platform Conical<br>Connection Abutment | K172505 | MIS Implants Technologies Ltd.<br>(Dentsply Sirona) |
| MIS Internal Hex Dental Implant<br>System | K180282 | MIS Implants Technologies Ltd.<br>(Dentsply Sirona) |
| Ankylos Balance Base Abutments | K122268 | Dentsply Sirona Implants<br>(Dentsply Sirona) |
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# 4. Description of Device:
The proposed MIS Angulated multi-unit abutments are endosseous dental implant abutments that are connected to MIS dental implants and used as an aid in prosthetic rehabilitation, for anchoring screw retained multiple-unit restorations.
MIS Angulated multi-unit abutments consist of a one-piece abutment and a prosthetic multi-unit screw, both made of Titanium complying with ASTM F136-13 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (USN R56401). The proposed abutments are available in 17° and 30° angulations and connected to the implant by a prosthetic multi-unit screw supplied with the proposed abutments. The proposed abutments are also supplied with a titanium gripping bar used to position the multi-unit abutment on the implant. The proposed abutments are supplied sterile to the user. Table 4.1 below summarizes the main specifications of the proposed MIS Angulated multi-unit abutments and the modifications made.
| Element | Specifications | Modifications/Changes |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Connection | -Conical (C1, V3)<br>-Internal-hex Connection (SEVEN, Lance +, M4) | Same connections<br>Proposed abutments are compatible with multiple conical and internal-hex connections |
| Platform | -Narrow Platform (NP)<br>-Standard Platform (SP)<br>-Wide Platform (WP) | New NP for angulated multi-unit abutments |
| Implant platform<br>diameter | -NP: Ø3.3 mm<br>-SP: Ø 3.75, 3.9, 4.2, 4.3, 5.0 mm<br>-WP: Ø 5.0, 6.0 mm | New NP<br>Other platform diameters remain the same. |
| Gingival height | -1 and 2 mm for NP<br>-3 mm for SP and WP | New gingival height of 3 mm for SP and WP |
| Angulations | 17° and 30° for all platforms | Same angulations |
| Prosthetic screw<br>Implant to<br>abutment | -Multi-unit screw for SP and WP:<br>MU-SOP01A (cleared in K163349)<br>-Screw for NP:<br>New, MU-SOPN1A | Same materials and same screw for SP and WP.<br>New multi-unit screw to fit the NP abutments |
Table 4.1: Specifications of the Proposed MIS Angulated multi-unit abutments
The proposed MIS cementing cap is a superstructure that has a standard connection design intended to be directly connected to all MIS straight and angulated multi-unit abutments with a prosthetic screw. The proposed cementing cap and prosthetic screw are made of Titanium complying with ASTM F136-13. Multi-unit cementing caps are delivered non-sterile, and are intended to be cleaned and steamsterilized by a professional user according to the instructions before use.
# 5. Indications for Use:
MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (03.30mm) 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
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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 & 20mm) implants can be used in a tilted manner. MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only.
# 6. Substantial Equivalence:
The design of the proposed MIS Angulated multi-unit abutments is based on the design of angulated multi-unit abutments cleared under primary predicate (K163349) and reference devices (K172505, K180282). The abutment diameter, implant-abutment-superstructure connection, and angulations are identical. The proposed MIS Angulated multi-unit abutments include a higher gingival height for Standard and Wide Platforms and are also available in a Narrow Platform.
An overview of the similarities and differences between the proposed and the primary predicate device (K163349) is given in Table 6.1. below. A discussion of the similarities and differences follows Table 6.1.
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# Table 6.1: Comparison between the proposed MIS Angulated multi-unit abutments and primary predicate device and reference devices
| Element | Proposed devices<br>MIS angulated multi-unit<br>abutments and cementing<br>cap | Primary predicate<br>MIS V3 conical<br>connection angulated<br>multi-unit abutments and<br>superstructure<br>(K163349) | Reference device<br>MIS Internal Hex<br>angulated multi-unit<br>abutment<br>(K180282) | Reference device<br>MIS C1 conical<br>connection angulated<br>multi-unit abutment<br>(K172505) | Reference device<br>Ankylos Balance Base<br>angulated multi-unit<br>abutment<br>(K122268) |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | MIS dental implant systems are<br>intended to be surgically placed<br>in the bone of the upper or<br>lower jaw arches to provide<br>support for prosthetic devices,<br>such as artificial teeth, in order<br>to restore masticatory function.<br>When a one-stage surgical<br>procedure is applied, the<br>implant may be immediately<br>loaded when good primary<br>stability is achieved and the<br>occlusal load is appropriate.<br>Narrow implants (Ø3.30mm)<br>are indicated for use in surgical<br>and restorative applications for<br>placement only in the<br>mandibular central, lateral<br>incisor and maxillary lateral<br>incisor regions of partially<br>edentulous jaws, to provide<br>support for prosthetic devices<br>such as artificial teeth.<br>Mandibular central and lateral<br>incisors must be splinted if<br>using two or more narrow<br>implants adjacent to one<br>another. The long MIS (18 &<br>20mm) implants can be used in<br>a tilted manner. MIS short<br>implants are to be used only<br>with straight abutments. M4<br>short implants are indicated for<br>delayed loading only. | MIS V3 Conical Connection<br>Dental Implant System is<br>intended to be surgically<br>placed in the bone of the upper<br>or lower jaw arches to provide<br>support for prosthetic devices,<br>such as artificial teeth, in order<br>to restore masticatory function.<br>When a one-stage surgical<br>procedure is applied, the<br>implant may be immediately<br>loaded when good primary<br>stability is achieved and the<br>occlusal load is appropriate.<br>Narrow implants (Ø3.3mm) are<br>indicated for use in surgical<br>and restorative applications for<br>placement only in the<br>mandibular central, lateral<br>incisor and maxillary lateral<br>incisor regions of partially<br>edentulous jaws, to provide<br>support for prosthetic devices<br>such as artificial teeth, in order<br>to restore the patient chewing<br>function. Mandibular central<br>and lateral incisors must be<br>splinted if using two or more<br>narrow implants adjacent to<br>one another. | MIS dental implant systems<br>are intended to be surgically<br>placed in the bone of the upper<br>or lower jaw arches to provide<br>support for prosthetic devices,<br>such as artificial teeth, in order<br>to restore masticatory function.<br>When a one-stage surgical<br>procedure is applied, the<br>implant may be immediately<br>loaded when good primary<br>stability is achieved and the<br>occlusal load is appropriate.<br>Narrow implants (Ø3.30mm &<br>UNO) are indicated for use in<br>surgical and restorative<br>applications for placement only<br>in the mandibular central,<br>lateral incisor and maxillary<br>lateral incisor regions of<br>partially edentulous jaws, to<br>provide support for prosthetic<br>devices such as artificial teeth.<br>Mandibular central and lateral<br>incisors must be splinted if<br>using two or more narrow<br>implants adjacent to one<br>another. The long MIS (18 &<br>20mm) implants can be used<br>in a tilted manner. MIS short<br>implants are to be used only<br>with straight abutments. M4<br>short implants are indicated for<br>delayed loading only. | MIS dental implant system is<br>intended to be surgically<br>placed in the bone of the upper<br>or lower jaw arches to provide<br>support for prosthetic devices,<br>such as artificial teeth, in order<br>to restore masticatory function.<br>When a one-stage surgical<br>procedure is applied, the<br>implant may be immediately<br>loaded when good primary<br>stability is achieved and the<br>occlusal load is appropriate.<br>Narrow implants (Ø3.3mm &<br>UNO) are indicated for use in<br>surgical and restorative<br>applications for placement only<br>in the mandibular central,<br>lateral incisor and maxillary<br>lateral incisor regions of<br>partially edentulous jaws, to<br>provide support for prosthetic<br>devices such as artificial teeth,<br>in order to restore the patient<br>chewing function. Mandibular<br>central and lateral incisors<br>must be splinted if using two or<br>more narrow implants adjacent<br>to one another. | The angled ANKYLOS®<br>Balance Base Abutments are<br>indicated for use in prosthetic<br>restorations with Ankylos®<br>implants and bridges or bar<br>overdentures using a minimum<br>of 2 implants. In edentulous<br>jaws, immediate loading is<br>possible using a minimum of 4<br>implants. Implants may be<br>tilted up to 45°. When used<br>with angulations between 30°<br>and 45° in edentulous arch, a<br>minimum of four implants must<br>be used and splinted. |
| Manufacturer | MIS Implants Technologies<br>Ltd. (Dentsply Sirona) | MIS Implants<br>Technologies Ltd.<br>(Dentsply Sirona) | MIS Implants<br>Technologies Ltd.<br>(Dentsply Sirona) | MIS Implants<br>Technologies Ltd.<br>(Dentsply Sirona) | Dentsply Sirona |
| Device Class | Class II | Class II | Class II | Class II | Class II |
| Product code(s) | NHA, Endosseous dental<br>implant abutment | NHA, Endosseous dental<br>implant abutment | NHA, Endosseous dental<br>implant abutment | NHA, Endosseous dental<br>implant abutment | NHA, Endosseous dental<br>implant abutment |
| Element | Proposed devices<br>MIS angulated multi-unit<br>abutments and cementing<br>cap | Primary predicate<br>MIS V3 conical<br>connection angulated<br>multi-unit abutments and<br>superstructure<br>(K163349) | Reference device<br>MIS Internal Hex<br>angulated multi-unit<br>abutment<br>(K180282) | Reference device<br>MIS C1 conical<br>connection angulated<br>multi-unit abutment<br>(K172505) | Reference device<br>Ankylos Balance Base<br>angulated multi-unit<br>abutment<br>(K122268) |
| Material | Titanium | Titanium | Titanium | Titanium | Titanium |
| Surface treatment | Polished and anodized /<br>Only polished | Polished and anodized after<br>machined | Polished after machined | Polished and anodized after<br>machined | Polished after machined |
| Screw connection | One abutment screw for<br>connection of the multi-unit<br>to the implant. Prosthetic<br>screw for connection of the<br>superstructure (cementing<br>cap) to the multi-unit | One abutment screw for<br>connection of the multi-<br>unit to the implant.<br>Prosthetic screw for<br>connection of the<br>temporary superstructure to<br>the multi-unit | One abutment screw for<br>connection of the multi-<br>unit to the implant.<br>Prosthetic screw for<br>connection of the<br>temporary superstructure to<br>the multi-unit | One abutment screw for<br>connection of the multi-<br>unit to the implant.<br>Prosthetic screw for<br>connection of the<br>temporary superstructure to<br>the multi-unit | Abutment screw for<br>connection to the implant.<br>2-piece abutment,<br>abutment head screws into<br>main abutment body.<br>Prosthetic screw for<br>connection to the abutment |
| Abutment-<br>superstructure<br>interface | Screw secured, with a plate<br>to plate sealing surface | Screw secured, with a plate<br>to plate sealing surface | Screw secured, with a plate<br>to plate sealing surface | Screw secured, with a plate<br>to plate sealing surface | Screw secured, with a plate<br>to plate sealing surface |
| Restoration | Multiple-units | Multiple-units | Multiple-units | Multiple-units | Multiple-units |
| Restoration type | Screw-retained | Screw-retained | Screw-retained | Screw-retained | Screw-retained |
| Abutment diameter | Ø 4.80 | Ø 4.80 | Ø 4.80 | Ø 4.80 | Ø 4.20 |
| Implant to<br>abutment<br>connection | -MIS C1 Conical<br>Connection<br>-MIS V3 Conical<br>Connection<br>-MIS SEVEN Internal Hex<br>-MIS M4 Internal Hex<br>-MIS Lance+ Internal Hex | MIS V3 Conical<br>Connection…
