MICRODENT GENIUS IMPLANT SYSTEM

• K Number: K141188
• Device Name: MICRODENT GENIUS IMPLANT SYSTEM
• Manufacturer: IMPLANT MICRODENT
• Date Cleared: 2015-06-02 ( 390 days)
• Product Code: DZE NHA
• Regulation Number: 872.3640

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 Description

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. Microdent Genius Implants are provided with blasted surface. The implants are supplied sterile and the abutments are provided non-sterile. Implants are also offered in various diameters and length. 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. 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. The Retention Screws are used for securing the abutments to the implant. 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. All abutments include appropriate features and dimensions to mate with Microdent Genius implants.

Predicate Devices

K083805

Reference Devices

K041509, K021318

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a standard dental implant system with mechanical components and does not mention any software, algorithms, or AI/ML capabilities.

Therapeutic

Yes.
This device is an implant system used to restore chewing function, which makes it a therapeutic device.

Diagnostic

No

The device description indicates it is a system of dental implants and prosthetic components used for surgical placement and restoration of chewing function, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of dental implants and prosthetic components, which are physical hardware.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
• Device Description: The Microdent Genius Implant System is a system of dental implants and prosthetic components designed for surgical placement in the jaw to restore chewing function. It is a physical implant and associated hardware.
• Intended Use: The intended use is for surgical placement in the jaw and restoration of chewing function. This is a surgical and restorative procedure, not a diagnostic test performed on a sample.

The description clearly indicates a device that is surgically implanted and used for mechanical support and restoration, which falls outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

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.

Microdent Genius Implants are provided with blasted surface.

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

Implants are also offered in various diameters and length.
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. Conical with flap abutment O 4.50 Height 1 to 6 mm
GNPCCP5001H Microdent Genius hex. Conical with flap abutment O 5.00 Height 1 to 6 mm
GNPCCP5501H Microdent Genius hex. Conical with flap abutment O 5.50 Height 1 to 6 mm
GNPCCP4501R Microdent Genius Circular Conical with flap abutment O 4.50 Height 1 to 6 mm
GNNPCCP5001R Microdent Genius Circular Conical with flap abutment O 5.00 Height 1 to 6 mm
GNPCCP5501R Microdent Genius Circular Conical with flap abutment O 5.50 Height 1 to 6 mm

Conical abutment without flap:
GNPCSP38H Microdent Genius Hex. Conical without flap abutment O 4.50 Height 1 to 6 mm
GNPCSP43H Microdent Genius Hex. Conical without flap abutment O 5.00 Height 1 to 6 mm
GNPCSP48H Microdent Genius Hex. Conical without flap abutment O 5.50 Height 1 to 6 mm

Immediate loading conical abutment:
GNPCI4501H Microdent Genius hex. immediate loading conical abutment O 4.50 Height 1 to 6 mm
GNPCI5001H Microdent Genius Hex. Conical without flap abutment O 5.00 Height 1 to 6 mm
GNPCI5501H Microdent Genius Hex. Conical without flap abutment O 5.50 Height 1 to 6 mm
GNPCI4501R Microdent Genius circular immediate loading conical abutment O 4.50 Height 1 to 6 mm
GNPCI5001R Microdent Genius circular immediate loading conical abutment O 5.00 Height 1 to 6 mm
GNPCI5501R Microdent Genius circular immediate loading conical abutment O 5.50 Height 1 to 6 mm
GNPAE154501H Microdent Genius hex Aesthetic Angled Abutment 15deg O 4.50 Height 1 to 5 mm
GNPAE204501H Microdent Genius hex Aesthetic Angled Abutment 20deg O 4.50 Height 1 to 5 mm
GNPAE254501H Microdent Genius hex Aesthetic Angled Abutment 25deg O 4.50 Height 1 to 5 mm
GNPAE155001H Microdent Genius hex Aesthetic Angled Abutment 15deg O 5.00 Height 1 to 5 mm
GNPAE205001H Microdent Genius hex Aesthetic Angled Abutment 20deg O 5.00 Height 1 to 5 mm
GNPAE255001H Microdent Genius hex Aesthetic Angled Abutment 25deg O 5.00 Height 1 to 5 mm
GNPAE155501H Microdent Genius hex Aesthetic Angled Abutment 15deg O 5.50 Height 1 to 5 mm
GNPAE205501H Microdent Genius hex Aesthetic Angled Abutment 20deg O 5.50 Height 1 to 5 mm
GNPAE255501H Microdent Genius hex Aesthetic Angled Abutment 25deg O 5.50 Height 1 to 5 mm
GNPASP3815H Microdent Genius hex Angled without flap Abutment 15deg O3.8 Height 0 mm
GNPASP3820H Microdent Genius hex Angled without flap Abutment 20deg O3.8 Height 0 mm
GNPASP3825H Microdent Genius hex Angled without flap Abutment O 3.80 25deg O3.8 Height 0 mm
GNPASP4315H Microdent Genius hex Angled without flap Abutment 15deg O4.3 Height 0 mm
GNPASP4320H Microdent Genius hex Angled without flap Abutment 20deg O4.3 Height 0 mm
GNPASP4325H Microdent Genius hex Angled without flap Abutment 15deg O4.3 Height 0 mm
GNPASP4815H Microdent Genius hex Angled without flap Abutment 15deg O4.8 Height 0 mm
GNPASP4820H Microdent Genius hex Angled without flap Abutment O 20deg O4.8 Height 0 mm
GNPASP4825H Microdent Genius hex Angled without flap Abutment 25deg O4.8 Height 0 mm
GNCAPN4801R Microdent Genius Circular Mini Capitel Abutment Ø 4.80 Height 1 to 6 mm
GNCAPNA 174801H Microdent Genius Hex Angled Mini Capitel abutment 17deg Ø 4.80 Height 1 to 2 mm
GNCAPNA 304801H Microdent Genius Hex Angled Mini Capitel abutment 30deg Ø 4.80 Height 1 to 2 mm
UTSNPC4X Microdent Genius Mini Capitel cementable coping Ø 4.80
UTSNCP4X Microdent Genius Mini Capitel Protective Cap Ø 4.80

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 abutment Ø 4.50 Height 1 to 6 mm
GNPR5001 Microdent Genius Healing abutment Ø 5.00 Height 1 to 6 mm
GNPR5501 Microdent Genius Healing abutment Ø 5.50 Height 1 to 6 mm
GNPCR3501 Microdent Genius Healing abutment Ø 3.50 Height 1 to 6 mm
The Retention Screws are used for securing the abutments to the implant.

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 Ø 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper or lower jaw arches

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical performance tests:
The proposed devices have been subject to bench testing to determine fulfillment of design and performance requirements. Bench testing followed the recommendations provided in FDA Guidance Document - Class II Special Controls Guidance Document for Endosseous Dental Implants and Endosseous Dental Implant Abutments and included static and dynamic fatigue testing in accordance with ISO 14801. Biocompatibility testing has been performed and ESEM/EDS analyses to determine adequate surface finish and cleaning. Package integrity testing and sterilization validation have been performed.

Clinical Testing:
No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalent.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K083805

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K041509, K021318

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.

Summary

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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.

1

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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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
Sta Eulalia de Ronçana
Barcelona, Barcelona E-08187
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.

4

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. .

5

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

Conical abutment without flap:

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

6

Immediate loading conical abutment:

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

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Angled abutment:

8

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

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

9

• 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

10

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

USP 37th ed. 2014 Bacterial Endotoxins Test

USP 37t0 ed. 2014 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.
Image: implant design	Same
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

11

12

Table 2: General Prosthetic Device Comparison

Characteristic	Subject Device	Predicate Device	SE / Comments
• Device Name	Microdent Genius implant
abutments	ANKYLOS C/X
Implant abutments	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, 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	The ANKYLOS® C/X Implant
System is for single-stage or
two-stage surgical procedures
and 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.	Yes (Genius
Microdent
specified the use
of small
diameter
implants)
		incisors in the maxillar and mandible.	Multiple tooth applications may
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
Screw	ANKYLOS Cover
Screw	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, 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.	The ANKYLOS® C/X Implant
System is for single-stage or
two-stage surgical procedures
and 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.	Yes (Genius
Microdent
specified the use
of small
diameter
implants
●	design;	One diameter and metric
thread M1.8	One diameter and
metric thread M1.8	yes
●	Collar Height (mm,
min -max)	Without heights	Without heights	yes
●	Seating Surface
(mm)	Diameter 2.9 mm.	Diameter
2.48 mm.	yes
●	connection type	Internal connection tapered.	Internal connection
tapered.	yes
●	sterilization	Sterile (Gamma irradiation)	same	Yes.
Packaged sterile
with the implant
●	Device Name	Microdent Genius	Ankylos
Regular	yes
		Healing Abutment	C/X
Gingiva
			Former
●	210K	NA	K083805
●	intended use/			Yes
(Genius
	indications for use	Microdent Genius Implant System
is	The ANKYLOS® C/X Implant	Microdent
		indicated for surgical placement in the	System is for single-stage or	specified the use
		upper or lower jaw arches, for single-stage	two-stage surgical procedures	of
small
		or two-stage surgical procedures and	and cemented or
screw	diameter
		cemented, screw retained restorations or	retained restorations.
The	implants
		overdentures. Microdent Genius Implant	ANKYLOS® C/X
		System
is
intended
for immediate
placement and function on single tooth	Implant System is intended for
immediate placement
and
		and/or multiple tooth applications when	function on single tooth and/or
		good primary stability is achieved, with	applications
multiple
tooth
		appropriate occlusal loading, in order to	when good primary stability is
		restore chewing function.	achieved,
with appropriate
		Small diameter implants are indicated only	occlusal loading, in order to
		for replacement of central and lateral	function.
restore
chewing
		incisors in the maxillar and mandible.	Multiple tooth applications may
			be splinted with a bar.
●	design;	diameters
3
and
metric	One diameter and	yes
		thread M1.8	metric thread M1.8
●	Collar Height (mm,	1 mm to 6 mm	0.75, 1.5, 3 and 4,5	yes
	min -max)		mm
●	Seating Surface	Diameter from 4.5, 5 and	Diameter	yes
	(mm)	5.5 mm.
			5.5 mm.
●	connection type	Internal connection tapered.	Internal connection	yes
			tapered
with
			indexation (/X) or
	Device Name	Microdent Genius	only tapered (C/)
Ankylos
Fixation
●		Retention screw	screw	yes
●	210K	NA	K083805
●	intended use/			(Genius
Yes
	indications for use	Microdent Genius Implant System	The ANKYLOS® C/X Implant	Microdent
		indicated for surgical placement in the	System is for single-stage or	specified the use
		upper or lower jaw arches, for single-stage	two-stage surgical procedures	of
small
		or two-stage surgical procedures and	and cemented
or
screw	diameter
		cemented, screw retained restorations or	retained restorations.
The	implants
		overdentures. Microdent Genius Implant	ANKYLOS® C/X

13

14

15

| | | 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. | 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. | |
|---|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| • | design; | This screw having
a threaded fuse and a head
with a hexagon 1.20 mm
flat to flat. | Similar geometry with hexagon 1.00 mm. | yes |
| • | Seating Surface
(mm) | This is a single Retention
screw for all platforms | same | yes |
| • | Device Name | Microdent Genius Conical
abutment | Ankylos Regular
C/X abutment and
Ankylos SynCone C/ | yes |
| • | 510K | NA | K083805

K041509 | |
| • | intended use/
indications for 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. | The ANKYLOS® C/X Implant
System is for single-stage or
two-stage surgical procedures
and 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. | Yes (Genius
Microdent
specified the use
of small
diameter
implants |
| • | design; | 3 diameters and same
connection (Microdent
Genius) | One diameter and
Ankylos
connection | yes |

16

	min -max)		mm
●	Seating Surface
(mm)	Diameter from 4.5, 5 and
5.5 mm.	Diameter
5.5 mm.	yes
●	connection type	Internal connection tapered
with indexation (H) or only
tapered (C).	Internal connection
tapered with
indexation (/X) or
only tapered (C/)	yes
●	Device Name	Microdent Genius Angled
abutment	Ankylos Regular
C/X abutment	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, 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.	The ANKYLOS® C/X Implant
System is for single-stage or
two-stage surgical procedures
and 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.	Yes (Genius
Microdent
specified the use
of small
diameter
implants
●	design;	3 diameters and same
connection (Microdent
Genius).

3 angulations 15°, 20° and
25°.

With flap (aesthetics) and
without flap. | One diameter and
Ankylos
connection.

5 angulations 7.5°,
15°, 22.5°, 30° and
37.5°.

With flap. | Yes
Without flap
provides shoulder
prosthesis
occultation in
cases of low
gingiva. |
| ● | Collar Height (mm,
min -max) | 1 mm to 5 mm | 0.75, 1.5, 3 and 4,5
mm | yes |

17

•	Seating Surface (mm)	Diameter from 4.5, 5 and 5.5 mm.	Diameter 5.5 mm.	yes
•	connection type	Internal connection tapered with indexation (H).	Internal connection tapered with indexation (/X) or only tapered (C/).	yes
•	Device Name	Microdent Genius Mini Capitel abutment	Ankylos Balance Base abutment C/	yes
•	510K	NA	K041509
•	intended use/ indications for 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.	An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.	Yes (Genius Microdent specified the use of small diameter implants. Ankylos Balance Base restricted the immediate loading to the anterior mandible, based 4 interforminal placed implants.
•	design;	One prosthetic diameter of 4,8 mm.
Angulations of 17° and 30°.	One prosthetic diameter of 4,2 mm.
Angulations of 15° and 30°.	yes
•	Collar Height (mm, min -max)	1 mm to 6 mm	0.75, 1.5, 3 and 4,5 mm	yes

18

| Seating Surface
●

(mm)	Diameter	Diameter	yes
	4.8 mm.	4.2 mm.
connection type
●	Internal connection tapered
(C).	Internal connection
tapered (C/)	yes
Copings
●	Cementable coping
of
Titanium (Grade 5)	cementable
Two
coping
of Gold
alloy.	yes
Device Name
●	Microdent Genius Osscilia
retention abutment	XiVE
Ball and
Socket Abutment
Ankylos
Snap
abutment C/.	yes
510K
●	NA	K021318
K083805
intended use/
●
indications for use	Microdent Genius Implant System
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
is
for immediate
System
intended
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.	The XiVE@ Dental Implant
System is indicated as follows:
once the implant has
osseointegrated, it serves to
support single tooth, bridge
and overdenture restorations.
In the edentulous mandible, a
minimum of four XiVE dental
implants (>9.5mm length) are
placed between the mental
foramina and rigidly splinted
together.
lm
this
case,
bar-prosthetic
loading
is
after
possible
immediately
implant placement.
The ANKYLOS® C/X Implant
System is for single-stage or
two-stage surgical procedures
screw
and
cemented or
retained restorations. The
ANKYLOS® C/X
System is intended
Implant
for immediate placement and
function on single tooth and/or
multiple
tooth applications
when good primary stability is
with appropriate
achieved,	Yes (but Genius
Microdent
specified the use
of
small
diameter
implants.
The
use of XiVE@
Dental
Implant
System
in
mandible
restricted
ದ
of of
minimum
XiVE
four
dental implants
(>9.5mm length)
placed
are
between
the
mental
foramina).

19

| | | occlusal loading, in order to
restore chewing function.
Multiple tooth applications may
be splinted with a bar. | |
|--------------------------------|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • design; | One prosthetic diameter of
3.5 mm.
Compensation 17°. | One prosthetic diameter of 3.1 mm. Compensation 20°. | Yes
XiVE Abutment consists of two parts, one which has the geometry of the implant connection and over the axis of the abutment. This characteristic differs from Genius and Ankylos but isn't relevant. |
| • Collar Height (mm, min -max) | 1 mm to 6 mm | 1.5, 3 and 4,5 mm | yes |
| • Seating Surface (mm) | Diameter 3.5 mm. | Diameter 3.1 mm. | yes |
| • connection type | Internal connection tapered (C). | Internal connection tapered (C/) | yes |

Microdent Genius Implant System is substantially equivalent intended use as the identified predicates. Microdent Genius Implant System is similar in fundamental scientific technology to the predicate devices in that they all have been designed, manufactured and tested in compliance with FDA'S Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

Microdent Genius Implant System is substantially equivalent in materials, indications and intended use, packaging, labeling and performance to the predicate devices currently marketed in the U.S.

The only differences the subject device and the predicate are slight differences in design and dimensions.

Non-Clinical performance tests

The proposed devices have been subject to bench testing to determine fulfillment of design and performance requirements. Bench testing followed the recommendations provided in FDA Guidance Document - Class II Special Controls Guidance Document for Endosseous Dental

20

Implants and Endosseous Dental Implant Abutments and included static and dynamic fatigue testing in accordance with ISO 14801. Biocompatibility testing has been performed and ESEM/EDS analyses to determine adequate surface finish and cleaning. Package integrity testing and sterilization validation have been performed.

G. Clinical Testing

No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalent.

H. Conclusion of Substantial Equivalence

Based on the similarities observed and results of non-clinical testing performed, we conclude that the proposed devices are substantially equivalent to the predicate devices.