MICRODENT GENIUS IMPLANT SYSTEM

K141188 · Implant Microdent · DZE · Jun 2, 2015 · Dental

Device Facts

• Record ID: K141188
• Device Name: MICRODENT GENIUS IMPLANT SYSTEM
• Applicant: Implant Microdent
• Product Code: DZE · Dental
• Decision Date: Jun 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Microdent Genius Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Genius Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Small diameter implants are indicated only for replacement of central and lateral incisors in the maxillar and mandible.

Device Story

Microdent Genius Implant System consists of endosseous dental implants and prosthetic components (abutments, cover screws, healing abutments). Implants are machined titanium with blasted surfaces, featuring internal tapered connections with indexation. Used in dental clinics by dentists/oral surgeons for tooth replacement. Implants are placed in jaw arches via single or two-stage surgery; can be immediately loaded if primary stability is sufficient. Prosthetic components (conical, angled, mini capitel, retention abutments) are attached to implants to support restorations. Device provides root-form foundation for chewing function restoration. Benefits include versatility in restoration types and immediate loading capability. System includes various diameters and lengths to accommodate anatomical requirements.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including static and dynamic fatigue testing per ISO 14801, biocompatibility testing, ESEM/EDS surface analysis, package integrity testing, and sterilization validation.

Technological Characteristics

Materials: Commercially pure titanium (Grade 4, ISO 5832-2) for implants; Titanium alloy (Grade 5) for abutments. Design: Parallel-walled, threaded, internal tapered connection with indexation. Surface: Blasted (0.82 μm roughness). Sterilization: Gamma irradiation. Dimensions: Diameters 3.5-5.0 mm; lengths 8-18 mm. Connectivity: Standalone mechanical system.

Indications for Use

Indicated for surgical placement in upper or lower jaw arches for single/two-stage procedures, cemented/screw-retained restorations, or overdentures. Supports immediate placement/function on single or multiple teeth with good primary stability and occlusal loading. Small diameter implants restricted to replacement of central and lateral incisors in maxilla and mandible.

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

• ANKYLOS C/X Dental Implant (K083805)
• ANKYLOS Balance Base abutment C/ (K041509)
• XiVE Dental Implant System (Ball and Socket Attachment) (K021318)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 2, 2015

Implant Microdent c/o Ms. Rhonda Alexander, M.S., M.P.A. Registrar Corp 144 Research Drive Hampton, VA 23666

Re: K141188

> Trade/Device Name: Microdent Genius Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 1, 2015 Received: May 4, 2015

Dear Ms. Alexander:

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-----------------------------------------|--|
| Food and Drug Administration | |

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141188

Device Name

Microdent Genius Implant System

#### Indications for Use (Describe)

Microdent Genius Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Genius Implant System is intended for immediate placement and function on single tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

Small diameter implants are indicated only for replacement of central incisors in the maxillar and mandible.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services [phone] EF |
|----------------------|---------------------|-------------------------------------------|
| | Andrew I. Steen -S | |
| | 2015.05.27 09:20:56 | Page 47 |

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# 510(k) SUMMARY (21 CFR 807.92)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92

The assigned 510(k) number is:

Premarket Notification [510(k)] Summary

| A. General Information | |
|------------------------|----------------------------------------------------------------------------------------------------|
| Submitter's Name: | Implant Microdent Systems |
| Address: | C/ Carles Buigas, 1 – Can Magre<br>Sta Eulalia de Ronçana<br>Barcelona, Barcelona E-08187<br>Spain |

| Telephone: | [phone] |
|-----------------|----------------------|
| Fax Number: | [phone] |
| Contact Person: | Jordi Clapes Donadeu |
| Date Prepared: | March 1, 2013 |

#### B. Device

| Trade Name: | Microdent Genius Implant System |
|----------------------|---------------------------------|
| Classification Name: | Endosseous Dental Implants |
| Product Code: | DZE and NHA |
| Class: | II |
| Regulation Number: | 21 CFR 872.3640 |

#### C. Identification of Legally Marketed Predicate Device

ANKYLOS C/X Dental Implant - K083805 (primary predicate) ANKYLOS Balance Base abutment C/ – K041509 (reference predicate) XiVE Dental Implant System (Ball and Socket Attachment) – K021318 (reference predicate)

#### D. Description of the Device

Microdent Genius Implant System is comprised of dental implants and prosthetic components. Microdent Genius dental implants are internal connection endosseous implants machined titanium that can be used with deferred load or immediate load techniques. If sufficient bone depth is available the implant can be inserted sub-crestal. Microdent Genius Implant is recommended to place 2mm sub-crestal position.

The implant has a connection formed by six grooves extending radially around the axis of the implant to provide a precise position of the abutment.

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Microdent Genius Implants are provided with blasted surface.

The implants are supplied sterile and the abutments are provided non-sterile.

| Ø platform | Ø core | Length | Reference |
|------------|--------|--------|-----------|
| 3.50 | 3.50 | 8 | GN3508 |
| | | 10 | GN3510 |
| | | 12 | GN3512 |
| | | 14 | GN3514 |
| | | 16 | GN3516 |
| | | 18 | GN3518 |
| 4.00 | 4.00 | 8 | GN4008 |
| | | 10 | GN4010 |
| | | 12 | GN4012 |
| | | 14 | GN4014 |
| | | 16 | GN4016 |
| | | 18 | GN4018 |
| 4.50 | 4.50 | 8 | GN4508 |
| | | 10 | GN4010 |
| | | 12 | GN4512 |
| | | 14 | GN4514 |
| | | 16 | GN4516 |
| | | 18 | GN4518 |
| 5.00 | 5.00 | 8 | GN5008 |
| | | 10 | GN5010 |
| | | 12 | GN5012 |
| | | 14 | GN5014 |
| | | 16 | GN5016 |

- Implants are also offered in various diameters and length. .

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- . Contained various Microdent Genius abutments made of Ti-6AL 4-V-ELI alloy.
The abutments Conical, Angled and Mini Capitel are used for cemented and screw-retained restorations.

Conical abutment with flap:

| GNPCCP4501H | Microdent Genius hex.<br>Conical with flap abutment | Ø 4.50<br>Height 1 to 6 mm |
|--------------|---------------------------------------------------------|----------------------------|
| GNPCCP5001H | Microdent Genius hex.<br>Conical with flap abutment | Ø 5.00<br>Height 1 to 6 mm |
| GNPCCP5501H | Microdent Genius hex.<br>Conical with flap abutment | Ø 5.50<br>Height 1 to 6 mm |
| GNPCCP4501R | Microdent Genius Circular<br>Conical with flap abutment | Ø 4.50<br>Height 1 to 6 mm |
| GNNPCCP5001R | Microdent Genius Circular<br>Conical with flap abutment | Ø 5.00<br>Height 1 to 6 mm |
| GNPCCP5501R | Microdent Genius Circular<br>Conical with flap abutment | Ø 5.50<br>Height 1 to 6 mm |

Conical abutment without flap:

| GNPCSP38H | Microdent Genius Hex. Conical<br>without flap abutment | Ø 4.50<br>Height 1 to 6 mm |
|-----------|--------------------------------------------------------|----------------------------|
| GNPCSP43H | Microdent Genius Hex. Conical<br>without flap abutment | Ø 5.00<br>Height 1 to 6 mm |
| GNPCSP48H | Microdent Genius Hex. Conical<br>without flap abutment | Ø 5.50<br>Height 1 to 6 mm |

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Immediate loading conical abutment:

| GNPCI4501H | Microdent Genius hex.<br>immediate loading conical<br>abutment | Ø 4.50<br>Height 1 to 6 mm |
|-----------------|--------------------------------------------------------------------|------------------------------|
| GNPCI5001H | Microdent Genius Hex. Conical<br>without flap abutment | Ø 5.00<br>Height 1 to 6 mm |
| GNPCI5501H | Microdent Genius Hex. Conical<br>without flap abutment | Ø 5.50<br>Height 1 to 6 mm |
| GNPCI4501R | Microdent Genius circular<br>immediate loading conical<br>abutment | Ø 4.50<br>Height 1 to 6 mm |
| GNPCI5001R | Microdent Genius circular<br>immediate loading conical<br>abutment | Ø 5.00<br>Height 1 to 6 mm |
| GNPCI5501R | Microdent Genius circular<br>immediate loading conical<br>abutment | Ø 5.50<br>Height 1 to 6 mm |
| GNPAE154501H | Microdent Genius hex Aesthetic<br>Angled Abutment 15° | Ø 4.50<br>Height 1 to 5 mm |
| GNPAE204501H | Microdent Genius hex Aesthetic<br>Angled Abutment 20° | Ø 4.50<br>Height 1 to 5 mm |
| GNPAE254501H | Microdent Genius hex Aesthetic<br>Angled Abutment 25° | Ø 4.50<br>Height 1 to 5 mm |
| GNPAE155001H | Microdent Genius hex Aesthetic<br>Angled Abutment 15° | Ø 5.00<br>Height 1 to 5 mm |
| GNPAE205001H | Microdent Genius hex Aesthetic<br>Angled Abutment 20° | Ø 5.00<br>Height 1 to 5 mm |
| GNPAE255001H | Microdent Genius hex Aesthetic<br>Angled Abutment 25° | Ø 5.00<br>Height 1 to 5 mm |
| GNPAE155501H | Microdent Genius hex Aesthetic<br>Angled Abutment 15° | Ø 5.50<br>Height 1 to 5 mm |
| GNPAE205501H | Microdent Genius hex Aesthetic<br>Angled Abutment 20° | Ø 5.50<br>Height 1 to 5 mm |
| GNPAE255501H | Microdent Genius hex Aesthetic<br>Angled Abutment 25° | Ø 5.50<br>Height 1 to 5 mm |
| GNPASP3815H | Microdent Genius hex Angled<br>without flap Abutment 15° | Ø3.8<br>Height 0 mm |
| GNPASP3820H | Microdent Genius hex Angled<br>without flap Abutment 20° | Ø3.8<br>Height 0 mm |
| GNPASP3825H | Microdent Genius hex Angled<br>without flap Abutment Ø 3.80 25° | Ø3.8<br>Height 0 mm |
| GNPASP4315H | Microdent Genius hex Angled<br>without flap Abutment 15° | Ø4.3<br>Height 0 mm |
| GNPASP4320H | Microdent Genius hex Angled<br>without flap Abutment 20° | Ø4.3<br>Height 0 mm |
| GNPASP4325H | Microdent Genius hex Angled<br>without flap Abutment 15° | Ø4.3<br>Height 0 mm |
| GNPASP4815H | Microdent Genius hex Angled<br>without flap Abutment 15° | Ø4.8<br>Height 0 mm |
| GNPASP4820H | Microdent Genius hex Angled<br>without flap Abutment Ø 20° | Ø4.8<br>Height 0 mm |
| GNPASP4825H | Microdent Genius hex Angled<br>without flap Abutment 25° | Ø4.8<br>Height 0 mm |
| GNCAPN4801R | Microdent Genius Circular Mini<br>Capitel Abutment | $Ø$ 4.80<br>Height 1 to 6 mm |
| GNCAPNA 174801H | Microdent Genius Hex Angled<br>Mini Capitel abutment 17° | $Ø$ 4.80<br>Height 1 to 2 mm |
| GNCAPNA 304801H | Microdent Genius Hex Angled<br>Mini Capitel abutment 30° | $Ø$ 4.80<br>Height 1 to 2 mm |
| UTSNPC4X | Microdent Genius Mini Capitel<br>cementable coping | $Ø$ 4.80 |
| UTSNCP4X | Microdent Genius Mini Capitel<br>Protective Cap | $Ø$ 4.80 |

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## Angled abutment:

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Mini Capitel abutment:

- A Cover screw protects the inner configuration of the implant and supplied sterile . with the implant.
- Healing abutment to shape the soft tissue during the healing phase. ●

| GNPR4501 | Microdent Genius Healing<br>abutment | $Ø$ 4.50<br>Height 1 to 6 mm |
|-----------|--------------------------------------|------------------------------|
| GNPR5001 | Microdent Genius Healing<br>abutment | $Ø$ 5.00<br>Height 1 to 6 mm |
| GNPR5501 | Microdent Genius Healing<br>abutment | $Ø$ 5.50<br>Height 1 to 6 mm |
| GNPCR3501 | Microdent Genius Healing<br>abutment | $Ø$ 3.50<br>Height 1 to 6 mm |

- The Retention Screws are used for securing the abutments to the implant. .

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- Overdenture retention consists of a titanium alloy socket that attached to a threaded post for use with titanium endosseous implants having an internal threaded socket. Both devices have a plastic component that has a shape on one and that mate into the titanium socket, while the other end with metal cap is attached to the denture.

| GNEOSS3500 | Microdent Genius Osscilia | $\varnothing$ 3.50 |
|------------|-------------------------------|--------------------|
| | retention abutment | Height 0 to 6 mm |
| CSUTGOSS | Metal cap with soft, middle | Titanium grade 5 |
| | and strong Osscilia retainer. | +POM |

All abutments include appropriate features and dimensions to mate with Microdent Genius implants.

#### E. Intended Use

Microdent Genius Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Genius Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

Small diameter implants are indicated only for replacement of central and lateral incisors in the maxillar and mandible.

#### F. Summary of Testing and Comparison to the Predicate Device

The devices are designed and manufactured in accordance with the following standards:

ISO 5832-2:1999 lmplants for surgery - Metallic materials - Part 2: Unalloyed titanium lSO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy

ISO 14971 Second edition 2007-03-01 Medical devices - Application of risk management to medical devices

ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants

ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

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ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity

USP 37th ed. 2014<85> Bacterial Endotoxins Test

USP 37t0 ed. 2014<151> Pyrogen Test

ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments -Biocontamination Control - Part 1: General Principles and Methods

ISO 14644-1:1999 Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness

ISO 14644-3:2005 Cleanrooms and associated controlled environments - Part 3: Test methods

ISO 11737-1:2006 (R)2011 Sterilization of medical devices - Microbiological methods Part 1: Determination of the population of microorganisms on product, 2ed

ISO 11737-2:2009 Sterilization of medical devices -- Microbiological methods --Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

ISO 11607-1:2006/(R)2010 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 11607-2:2006/(R)2010 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

ISO 11137-1:2006/(R) 2010 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

ISO 11137-3:2006/(R)2010 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects.

ASTM F1980-07 (Reapproved 2011), Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices. (Sterility).

ANSI / AAMI ST79: 2010& A1:2010 & A2:2011 & A3:2012 & A4:2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities

#### Comparison of Technological Characteristics

#### Table 1: General Implant Device Comparison

| Characteristic | Subject Device | Predicate Device | SE / Comments |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| • Device Name | Microdent Genius implant | ANKYLOS C/X Implant | yes |
| • 510K | NA | K083805 | |
| • intended use/ indications for use | Microdent Genius Implant System is indicated for surgical placement in the upper or lower jaw arches, | The ANKYLOS® C/X Implant System is for single-stage or two-stage surgical procedures and | Yes (Genius Microdent specified the use |
| for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Genius Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Small diameter implants are indicated only for replacement of central and lateral incisors in the maxillar and mandible. | | cemented or screw retained restorations. The ANKYLOS® C/X Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar. | of small diameter implants) |
| • material | Comercially pure titanium (grade 4 as ISO 5832-2) | Comercially pure titanium (grade 2 as ISO 5832-2) | Yes (different degree but with very similar properties) |
| • design; | Parallel-walled and threaded.<br>Image: implant design | Same<br>Image: implant design | yes |
| • length (mm) | 8, 10, 12, 14, 16 and 18 mm. | 8, 9.5, 11, 14 and 17 mm | yes |
| • diameter (mm) | Diameter ranges: 3.5 mm, 4.0 mm, 4.5 mm and 5.00 mm. | Diameter ranges: 3.5 mm, 4.5 mm, 5.5 mm and 7.0 mm. | Yes (ANKYLOS also has a diameter of 7.0 mm) |
| • connection type | Internal connection tapered with indexation. | Internal connection tapered with indexation. | yes |
| • surface treatment | Blasting (roughness 0,82 μm peak-to-valley). | Grit-blasted sand high-temperature etched (roughness 2,75 μm peak-to-valley). | yes (different treatment with similar result) |
| • sterilization | Sterile (Gamma irradiation) | same | yes |
| • Packaging | Packaged with sterile vial with cover screw | Packaged with sterile blister with cover screw | yes |
| • Shelf Life | 5 years | 5 years | yes |
| • Mating Components | All Microdent Restorative Components | All ANKYLOS C/X Restorative Components | yes |

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## Table 2: General Prosthetic Device Comparison

| Characteristic | Subject Device | Predicate Device | SE / Comments | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| • Device Name | Microdent Genius implant<br>abutments | ANKYLOS C/X<br>Implant abutments | yes | |
| • 510K | NA | K083805 | | |
| • intended use/<br>indications for use | Microdent Genius Implant System is<br>indicated for surgical placement in the<br>upper or lower jaw arches, for single-stage<br>or two-stage surgical procedures and<br>cemented, screw retained restorations or<br>overdentures. Microdent Genius Implant<br>System is intended for immediate<br>placement and function on single tooth<br>and/or multiple tooth applications when<br>good primary stability is achieved, with<br>appropriate occlusal loading, in order to<br>restore chewing function.<br>Small diameter implants are indicated only<br>for replacement of central and lateral | The ANKYLOS® C/X Implant<br>System is for single-stage or<br>two-stage surgical procedures<br>and cemented or screw<br>retained restorations. The<br>ANKYLOS® C/X<br>Implant System is intended for<br>immediate placement and<br>function on single tooth and/or<br>multiple tooth applications<br>when good primary stability is<br>achieved, with appropriate<br>occlusal loading, in order to<br>restore chewing function. | Yes (Genius<br>Microdent<br>specified the use<br>of small<br>diameter<br>implants) | |
| | | incisors in the maxillar and mandible. | Multiple tooth applications may<br>be splinted with a bar. | |
| ● | material | Titanium alloy (Grade 5). | same | yes |
| ● | surface treatment | Polished. | same | yes |
| ● | sterilization | No sterile | same | yes |
| ● | Packaging | Blister | same | yes |
| ● | Device Name | Microdent Genius Cover<br>Screw | ANKYLOS Cover<br>Screw | yes |
| ● | 510K | NA | K083805 | |
| ● | intended use/<br>indications for use | Microdent Genius Implant System is<br>indicated for surgical placement in the<br>upper or lower jaw arches, for single-stage<br>or two-stage surgical procedures and<br>cemented, screw retained restorations or<br>overdentures. Microdent Genius Implant<br>System is intended for immediate<br>placement and function on single tooth<br>and/or multiple tooth applications when<br>good primary stability is achieved, with<br>appropriate occlusal loading, in order to<br>restore chewing function.<br>Small diameter implants are indicated only<br>for replacement of central and lateral<br>incisors in the maxillar and mandible. | The ANKYLOS® C/X Implant<br>System is for single-stage or<br>two-stage surgical procedures<br>and cemented or screw<br>retained restorations. The<br>ANKYLOS® C/X<br>Implant System is intended for<br>immediate placement and<br>function on single tooth and/or<br>multiple tooth applications<br>when good primary stability is<br>achieved, with appropriate<br>occlusal loading, in order to<br>restore chewing function.<br>Multiple tooth applications may<br>be splinted with a bar. | Yes (Genius<br>Microdent<br>specified the use<br>of small<br>diameter<br>implants |
| ● | design; | One diameter and metric<br>thread M1.8 | One diameter and<br>metric thread M1.8 | yes |
| ● | Collar Height (mm,<br>min -max) | Without heights | Without heights | yes |
| ● | Seating Surface<br>(mm) | Diameter 2.9 mm. | Diameter<br>2.48 mm. | yes |
| ● | connection type | Internal connection tapered. | Internal connection<br>tapered. | yes |
| ● | sterilization | Sterile (Gamma irradiation) | same | Yes.<br>Packaged sterile<br>with the implant |
| ● | Device Name | Microdent Genius | Ankylos<br>Regular | yes |
| | | Healing Abutment | C/X<br>Gingiva | |
| | | | Former | |
| ● | 210K | NA | K083805 | |
| | | | | |
| ● | intended use/ | |…