MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System

K251647 · Dentsply Sirona, Inc. · DZE · Aug 21, 2025 · Dental

Device Facts

• Record ID: K251647
• Device Name: MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System
• Applicant: Dentsply Sirona, Inc.
• Product Code: DZE · Dental
• Decision Date: Aug 21, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 (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. MIS SEVEN short implants are to be used only with straight abutments. 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 (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. 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 (Ø3.30 mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only.

Device Story

Endosseous dental implants (C1, Seven, M4, Lance+) surgically placed in jaw bone; provide support for prosthetic devices (artificial teeth) to restore masticatory function. Implants supplied sterile with cover screws; titanium alloy (Ti-6Al-4V ELI) construction. Used by dental surgeons in clinical settings. Implants may be immediately loaded if primary stability is achieved; narrow implants require splinting in specific incisor regions. Output is a stable foundation for dental prosthetics. Benefits include restoration of oral function. Packaging includes inner tubes (wet or dry) and blister packs. No changes to implant design or material; minor packaging design updates validated via performance testing.

Clinical Evidence

Bench testing only. Evidence includes hydrophilicity testing (sessile drop test), biocompatibility (ISO 10993-1), sterilization validation (ISO 11737), fatigue testing (ISO 14801), and MR conditional testing (ASTM F2052, F2119). Packaging integrity validated via ASTM standards (D4169, F88, F1929, F2096). No clinical data required.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136). Connection types: Conical (12°) and Internal Hex. Sterilization: Gamma irradiation (SAL 10^-6). Packaging: Inner tube (wet/dry) and Tyvek blister pack. Shelf life: 1 year. No software or electronic components.

Indications for Use

Indicated for patients requiring dental implants in upper or lower jaw arches to support prosthetic devices and restore masticatory function. Narrow implants (Ø3.3mm) restricted to mandibular central/lateral incisors and maxillary lateral incisors in partially edentulous jaws; requires splinting for adjacent narrow implants. Specific constraints: short implants limited to straight abutments; M4 short implants restricted to delayed loading.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• MIS LYNX Conical Connection Implant System (K241692)

Reference Devices

• MIS C1 Implant System (K172505, K200102)
• MIS Seven Implant System (K180282, K200102)
• MIS M4 Implant System (K180282)
• MIS Lance+ Implant System (K192149, K200102)
• MIS Lance+ Conical Connection (K210886)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

Dentsply Sirona Inc.
Melanie Avila
Regulatory Affairs Director
221 West Philadelphia St.
Suite 60W
York, Pennsylvania 17401

August 21, 2025

Re: K251647
Trade/Device Name: MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System
Regulation Number: 21 CFR 872.3640
Regulation Name: Endosseous Dental Implant
Regulatory Class: Class II
Product Code: DZE, NHA
Dated: May 29, 2025
Received: May 29, 2025

Dear Melanie Avila:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251647 - Melanie Avila
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K251647 - Melanie Avila
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Andrew I. Steen -S

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 Quality
Center for Devices and Radiological Health

Enclosure

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MIS Implants System

| Indications for Use | |
| --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K251647 ? |
| Please provide the device trade name(s). | ? |
| • MIS C1 Implant System
• MIS Seven Implant System
• MIS M4 Implant System
• MIS Lance+ Implant System
• MIS Lance+ Conical Connection System | |
| Please provide your Indications for Use below. | ? |
| MIS Dental Implants Systems
• MIS C1 Implant System
• MIS SEVEN 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 (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.
MIS SEVEN short implants are to be used only with straight abutments.
• MIS Lance+ Implant System
• MIS Lance+ Conical Connection 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 (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.
• MIS M4 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 (Ø3.30 mm) are indicated for use in surgical and restorative applications for placement
only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous
jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors
must be splinted if using two or more narrow implants adjacent to one another.
MIS short implants are to be used only with straight abutments.
M4 short implants are indicated for delayed loading only. | |

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MIS Implants System

Please select the types of uses (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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Dentsply Sirona Inc
221 West Philadelphia Street
Suite 60W
York, PA 17401
K251647

510(k) SUMMARY

1. Submitter Information:
Dentsply Sirona Inc.
221 West Philadelphia Street
Suite 60W
York, PA 17401

Contact Person: Melanie Avila
Telephone Number: 210-262-7724
Email address: [e-mail]

Date Prepared: August 7, 2025

2. Device Name:
Device Trade Name
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System

Classification Name: Endosseous Dental Implant

Regulation Number 872.3640
Device Class: Class II
Product Code: DZE (Primary Product Code)
NHA (Secondary Product Code)

3. Predicate Device:

| Primary Predicate Device | 510(k) | Company Name |
| --- | --- | --- |
| MIS LYNX Conical Connection Implant System | K241692 | MIS (part of Dentsply Sirona Inc) |
| Reference Devices | 510(k) | Company Name |
| --- | --- | --- |
| MIS C1 Implant System | K172505 (Dry configuration), K200102 (CLEAR configuration) | MIS (part of Dentsply Sirona Inc) |
| MIS Seven Implant System | K180282 (Dry configuration), K200102 (CLEAR configuration) | MIS (part of Dentsply Sirona Inc) |
| MIS M4 Implant System | K180282 | MIS (part of Dentsply Sirona Inc) |
| MIS Lance+ Implant System | K192149 (Dry configuration), K200102 (CLEAR configuration) | MIS (part of Dentsply Sirona Inc) |
| MIS Lance+ Conical Connection | K210886 (Dry and CLEAR configuration) | MIS (part of Dentsply Sirona Inc) |

Dentsply Sirona

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4. Description of Device:

The subject devices, MIS Implants, are supplied sterile and packaged together with a cover screw which can be connected to the implant during the initial healing period after implant placement.

The implants and cover screws are made of titanium alloy (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The design and material of the implants and cover screws remain unchanged since most recently cleared 510(k).

The implants are also used with a wide range of previously cleared abutments which are sold separately.

| Implant | Connection type | Diameter (mm) | Length (mm) | Anodize color |
| --- | --- | --- | --- | --- |
| MIS C1/C1 CLEAR NP | Conical, Cone angulation 12° | 3.30 | 10, 11.5, 13, 16 | Yellow / None ("wet") |
| MIS C1/C1 CLEAR SP | Conical, Cone angulation 12° | 3.75, 4.20 | 8, 10, 11.5, 13, 16 | Purple / None ("wet") |
| MIS C1/C1 CLEAR WP | Conical, Cone angulation 12° | 5.0 | 8, 10, 11.5, 13, 16 | Green / None ("wet") |
| MIS SEVEN/SEVEN CLEAR NP | Internal hex | 3.30 | 10, 11.5, 13, 16 | Yellow / None ("wet") |
| MIS SEVEN/SEVEN CLEAR SP | Internal hex | 3.75 | 8, 10, 11.5, 13, 16 | Purple / None ("wet") |
| MIS SEVEN/SEVEN CLEAR SP | Internal hex | 4.20 | 6, 8, 10, 11.5, 13, 16 | Purple / None ("wet") |
| MIS SEVEN/SEVEN CLEAR WP | Internal hex | 5.0 | 6, 8, 10, 11.5, 13, 16 | Green / None ("wet") |
| MIS SEVEN/SEVEN CLEAR WP | Internal hex | 6.0 | 6, 8, 10, 11.5, 13 | Green / None ("wet") |
| MIS M4 NP | Internal hex | 3.30 | 10, 11.5, 13, 16 | None |
| MIS M4 SP | Internal hex | 3.75 | 8, 10, 11.5, 13, 16 | None |
| MIS M4 SP | Internal hex | 4.20 | 6, 8, 10, 11.5, 13, 16 | None |
| MIS M4 WP | Internal hex | 5.0 | 6, 8, 10, 11.5, 13, 16 | None |
| MIS M4 WP | Internal hex | 6.0 | 6, 8, 10, 11.5, 13 | None |
| MIS Lance+/Lance+ Clear NP | Internal hex / Conical connection, Cone angulation 12° | 3.30 | 10, 11.5, 13, 16 | Yellow / None ("wet") |
| MIS Lance+/Lance+ Clear SP | Internal hex / Conical connection, Cone angulation 12° | 3.75, 4.20 | 8, 10, 11.5, 13, 16 | Purple / None ("wet") |
| MIS Lance+/Lance+ Clear WP | Internal hex / Conical connection, Cone angulation 12° | 5.0 | 8, 10, 11.5, 13, 16 | Green / None ("wet") |
| MIS Lance+/Lance+ Clear WP | Internal hex | 6.0 | 8, 10, 11.5, 13 | Green / None ("wet") |
| Cover screw NP | Internal hex | 3.3 | 4.7 | Yellow |
| Cover screw SP | Internal hex | 3.8 | 4.7 | Purple |

Dentsply Sirona

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Dentsply Sirona

5. Indications for Use:

| MIS Internal Hex Implant Dental System
MIS M4 Implant System

Subject Device | MIS Dental Implants Systems
• MIS C1 Implant System
• MIS Seven Implant System

Subject Device | MIS Lance+ Conical Connection Implant System
• MIS Lance+ Implant System
• MIS Lance+ Conical Connection Implant System

Subject Device |
| --- | --- | --- |
| 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 (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.
M4 short implants are indicated for delayed loading only. | 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 (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 Dental Implant System is intended to be surgically placed in the bone of the upper and 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 in 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. |

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| Summary of the technological characteristics of the device compared to the predicate device [21 CFR 807.92(a)(6)] | | | | | |
| --- | --- | --- | --- | --- | --- |
| Attribute | -MIS M4 Implant System | -MIS C1 Implant System -MIS Seven Implant System | -MIS Lance+ Conical Connection Implant System -MIS Lance+ Implant System | -MIS Lynx Conical Connection Implant System | Comparison |
| | MIS Implant System Subject Device | MIS Implant System Subject Device | MIS Implant System Subject Device | Predicate Device | N/A |
| 510(k) Submitter/Holder | Dentsply Sirona Inc | Dentsply Sirona Inc | Dentsply Sirona Inc | Dentsply Sirona Inc | N/A |
| 510(k) number | K251647 | K251647 | K251647 | K241692 | N/A |
| Indications for use (IFU) statement | 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. | 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. | 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. | MIS Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic device, 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 in appropriate. | Similar – The IFU statements are similar, with the exception of the of the limitation statement for short implants for M4, C1, and SEVEN. This limitation statement does not apply to Lynx, Lance+, and Lance + Conical. |

Dentsply Sirona

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Dentsply Sirona
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| | 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. M4 short implants are indicated for delayed loading only. | 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 SEVEN short implants are to be used only with straight abutments. | 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. | 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. | |
| Technological Characteristics - Implant | | | | | |
| Material | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | Same |
| Sterility Method | Gamma irradiation | Gamma irradiation | Gamma irradiation | Gamma irradiation | Same |
| SAL | 10^{-6} | 10^{-6} | 10^{-6} | 10^{-6} | Same |
| Shelf Life | 1 year | 1 year | 1 year | 1 year | Same |
| Packaging | | | | | |
| Primary | N/A – The M4 | Inner tube | Inner tube which | Inner tube which | Similar – there is |

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Dentsply Sirona

| Packaging
(CLEAR
Packaging
Configuration) | Implant System is not offered in CLEAR Packaging. | which contains the implant and cover screw in sodium chloride (NaCl) solution | contains the implant and cover screw in sodium chloride (NaCl) solution | contains the implant and cover screw in sodium chloride (NaCl) solution | no change to the packaging materials, however there are slight changes to the design of the inner tube dimensions, inner tube cap, and inner tube titanium stage and ring. These minor design changes do not impact the device safety or performance as demonstrated by the results of performance testing, shelf, and sterilization. |
| --- | --- | --- | --- | --- | --- |
| Primary Packaging (Dry Packaging Configuration) | Inner tube which contains the implant and cover screw packaged in air | Inner tube which contains the implant and cover screw packaged in air | Inner tube which contains the implant and cover screw packaged in air | Inner tube which contains the implant and cover screw packaged in air | Similar – there is no change to the packaging materials, however there are slight changes to the design of the inner tube dimensions, inner tube cap, and inner tube titanium stage and ring. These minor design changes do not impact the device safety or performance as demonstrated by the results of performance testing, shelf, and sterilization. |
| Secondary Packaging | Blister pack with heat-seal coated Tyvek | Blister pack with heat-seal coated Tyvek | Blister pack with heat-seal coated Tyvek | Blister pack with heat-seal coated Tyvek | Same |
| Tertiary Packaging | cardboard box | cardboard box | cardboard box | cardboard box | Same |
| Performance Testing | | | | | |
| Hydrophilicity | N/A – The M4 Implant System is not offered in CLEAR Packaging. | Pass | Pass | Pass | Same – All CLEAR samples tested met the acceptance criteria of 0-5° Contact Angle |

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Performance Data

Summary of non-clinical tests conducted for determination of substantial equivalence:

Hydrophilicity testing, which is an internal test method, was performed per sessile drop test, on the proposed implants to support substantial equivalence and to demonstrate the minor changes to the primary packaging from the predicate device do not impact the requirement of a super-hydrophilic surface for the wet-packed implants over the shelf life of the device.

In all instances, the subject device functioned as intended and all test results observed were as expected.

The testing generated strong evidence that the subject devices are found to be substantially equivalent to the predicate device

The following testing and analysis were leveraged from the predicate (K241692) and reference devices:

- Biocompatibility Testing per ISO 10993-1, Biological evaluation of medical devices
- Sterilization per ISO 11737-1:2018 Sterilization of health care products Microbiological methods
- Transportation Testing per ASTM D4169-22 - Standard Practice for Performance Testing of Shipping Containers and Systems and ASTM D4332-22 - Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- Shelf Life Testing per ISO 11607-1:2019 Packaging for terminally sterilized medical devices-Part1: Requirements for materials, sterile barrier systems and packaging systems, ASTM F 1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration, ASTM F88/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier Materials, ASTM F2096-11 (Reapproved 2019) Standard Test for detecting gross leaks in packaging by internal pressurization (Bubble test), ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, and ISO 11737-2:2019(E) Sterilization of health care products – Microbiological methods –Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- Fatigue Testing per ISO 14801:2016 Dentistry - Implants - Dynamic fatigue tests for endosseous dental implant and FDA's Guidance - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments
- Surface Modification Characterization by SEM (scanning electron microscope) to demonstrate surface cleanliness

MR Conditional Testing per Magnetically induced displacement force, according to ASTM F2052-21, Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment, Image Artifact, according to ASTM F2119-07 (2013), Standard test method for evaluation of MR image artifacts from passive implants, and RF Induced Heating Simulation using Computational modeling and simulation (CM&S)

Clinical testing was not necessary to demonstrate equivalence.

Conclusions

The subject devices, MIS Implant Systems and the predicate device have the same intended use and similar indications for use. MIS Implant Systems and the predicate device have the similar technological characteristics and principles of operation. The proposed change for the primary and secondary packaging of the implant and cover screw is similar to the primary packaging and the same as the secondary packaging for the Lynx Conical Connection Implant System, cleared under 510(k) K241692.

No other changes have been made to the implant design, technological characteristics or intended use since the most recently cleared 510(k) for each of the MIS Implants Systems.

The minor differences in primary packaging do not present different questions of safety or effectiveness than the predicate device because the subject device functions to the same packaging performance specifications as the predicate device. Thus, the primary packaging for the subject device, MIS Implant Systems, is substantially equivalent to the primary packaging of the predicate device.

The subject device is substantially equivalent as the predicate device.

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Dentsply Sirona