(390 days)
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.
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.
The provided document is a 510(k) Premarket Notification for the Microdent Genius Implant System, dating back to 2015. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness de novo. Therefore, the information provided is primarily a comparison to predicate devices and describes non-clinical testing for compliance with standards, rather than a study designed to meet specific acceptance criteria for performance as would be seen for complex diagnostic or AI devices.
Based on the provided text, here's a breakdown of the requested information:
Acceptance Criteria and Device Performance
Since this is a 510(k) submission for a dental implant system (a medical device, not an AI/diagnostic device), the "acceptance criteria" are compliance with established ISO standards and demonstration of substantial equivalence to a predicate device. The "device performance" is therefore shown through successful completion of these non-clinical tests and the comparison of characteristics.
| Acceptance Criteria (Compliance with Standards/Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Material: Commercially pure titanium (ISO 5832-2) | Comercially pure titanium (grade 4 as ISO 5832-2) |
| Biocompatibility: ISO 10993-1, -5, USP <85>, <151> | Passed biocompatibility testing, ESEM/EDS analyses, Bacterial Endotoxins Test, Pyrogen Test |
| Sterilization: ISO 11137-1, -2, -3; ANSI/AAMI ST79 | Sterile (Gamma irradiation) and validation completed |
| Packaging: ISO 11607-1, -2; ASTM F1980-07 | Package integrity testing and validation completed |
| Dynamic Fatigue Test: ISO 14801 | Passed dynamic fatigue testing |
| Risk Management: ISO 14971 | Designed and manufactured in accordance with ISO 14971 |
| Intended Use Equivalence | Substantially equivalent to predicate devices' intended use (with specific minor differences noted, e.g., small diameter implant use, immediate loading restrictions) |
| Design/Dimensions Equivalence | Similar in fundamental scientific technology; slight differences in design and dimensions compared to predicate. |
Additional Requested Information:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The document refers to "bench testing" and "analyses" without providing specific numbers of implants or abutments tested for each non-clinical performance test.
- Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting on manufactured devices, not using patient data. The manufacturer (Implant Microdent Systems) is located in Spain.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission. "Ground truth" in the context of expert consensus is typically relevant for diagnostic devices (especially AI/imaging devices) where human experts determine the true condition of a patient based on clinical data. For this dental implant system, the "truth" is determined by compliance with engineering and material standards and performance under simulated conditions.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically employed in studies where human readers are interpreting data, and disagreements need to be resolved. This document details non-clinical laboratory testing.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a dental implant system, not a diagnostic or AI device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant to this submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a dental implant system, not an algorithm or AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering standards and material specifications (e.g., ISO standards). Tests were performed according to these standards (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility), and the device's adherence to these predefined criteria serves as the "truth." There is no clinical "truth" from patients or expert consensus in this non-clinical submission.
-
The sample size for the training set:
- This information is not applicable. There is no "training set" in the context of a dental implant system's 510(k) submission. This concept is relevant for AI/machine learning models.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
{0}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
{2}------------------------------------------------
| 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 (301) 443-6740 EF |
|---|---|---|
| Andrew I. Steen -S | ||
| 2015.05.27 09:20:56 | Page 47 |
{3}------------------------------------------------
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 MagreSta Eulalia de RonçanaBarcelona, Barcelona E-08187Spain |
| Telephone: | +34-902-402-420 |
|---|---|
| Fax Number: | +34-94-844-7893 |
| 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 4.50Height 1 to 6 mm |
|---|---|---|
| GNPCCP5001H | Microdent Genius hex.Conical with flap abutment | Ø 5.00Height 1 to 6 mm |
| GNPCCP5501H | Microdent Genius hex.Conical with flap abutment | Ø 5.50Height 1 to 6 mm |
| GNPCCP4501R | Microdent Genius CircularConical with flap abutment | Ø 4.50Height 1 to 6 mm |
| GNNPCCP5001R | Microdent Genius CircularConical with flap abutment | Ø 5.00Height 1 to 6 mm |
| GNPCCP5501R | Microdent Genius CircularConical with flap abutment | Ø 5.50Height 1 to 6 mm |
Conical abutment without flap:
| GNPCSP38H | Microdent Genius Hex. Conicalwithout flap abutment | Ø 4.50Height 1 to 6 mm |
|---|---|---|
| GNPCSP43H | Microdent Genius Hex. Conicalwithout flap abutment | Ø 5.00Height 1 to 6 mm |
| GNPCSP48H | Microdent Genius Hex. Conicalwithout flap abutment | Ø 5.50Height 1 to 6 mm |
{6}------------------------------------------------
Immediate loading conical abutment:
| GNPCI4501H | Microdent Genius hex.immediate loading conicalabutment | Ø 4.50Height 1 to 6 mm |
|---|---|---|
| GNPCI5001H | Microdent Genius Hex. Conicalwithout flap abutment | Ø 5.00Height 1 to 6 mm |
| GNPCI5501H | Microdent Genius Hex. Conicalwithout flap abutment | Ø 5.50Height 1 to 6 mm |
| GNPCI4501R | Microdent Genius circularimmediate loading conicalabutment | Ø 4.50Height 1 to 6 mm |
| GNPCI5001R | Microdent Genius circularimmediate loading conicalabutment | Ø 5.00Height 1 to 6 mm |
| GNPCI5501R | Microdent Genius circularimmediate loading conicalabutment | Ø 5.50Height 1 to 6 mm |
| GNPAE154501H | Microdent Genius hex AestheticAngled Abutment 15° | Ø 4.50Height 1 to 5 mm |
| GNPAE204501H | Microdent Genius hex AestheticAngled Abutment 20° | Ø 4.50Height 1 to 5 mm |
| GNPAE254501H | Microdent Genius hex AestheticAngled Abutment 25° | Ø 4.50Height 1 to 5 mm |
| GNPAE155001H | Microdent Genius hex AestheticAngled Abutment 15° | Ø 5.00Height 1 to 5 mm |
| GNPAE205001H | Microdent Genius hex AestheticAngled Abutment 20° | Ø 5.00Height 1 to 5 mm |
| GNPAE255001H | Microdent Genius hex AestheticAngled Abutment 25° | Ø 5.00Height 1 to 5 mm |
| GNPAE155501H | Microdent Genius hex AestheticAngled Abutment 15° | Ø 5.50Height 1 to 5 mm |
| GNPAE205501H | Microdent Genius hex AestheticAngled Abutment 20° | Ø 5.50Height 1 to 5 mm |
| GNPAE255501H | Microdent Genius hex AestheticAngled Abutment 25° | Ø 5.50Height 1 to 5 mm |
| GNPASP3815H | Microdent Genius hex Angledwithout flap Abutment 15° | Ø3.8Height 0 mm |
| GNPASP3820H | Microdent Genius hex Angledwithout flap Abutment 20° | Ø3.8Height 0 mm |
| GNPASP3825H | Microdent Genius hex Angledwithout flap Abutment Ø 3.80 25° | Ø3.8Height 0 mm |
| GNPASP4315H | Microdent Genius hex Angledwithout flap Abutment 15° | Ø4.3Height 0 mm |
| GNPASP4320H | Microdent Genius hex Angledwithout flap Abutment 20° | Ø4.3Height 0 mm |
| GNPASP4325H | Microdent Genius hex Angledwithout flap Abutment 15° | Ø4.3Height 0 mm |
| GNPASP4815H | Microdent Genius hex Angledwithout flap Abutment 15° | Ø4.8Height 0 mm |
| GNPASP4820H | Microdent Genius hex Angledwithout flap Abutment Ø 20° | Ø4.8Height 0 mm |
| GNPASP4825H | Microdent Genius hex Angledwithout flap Abutment 25° | Ø4.8Height 0 mm |
| GNCAPN4801R | Microdent Genius Circular MiniCapitel Abutment | $Ø$ 4.80Height 1 to 6 mm |
| GNCAPNA 174801H | Microdent Genius Hex AngledMini Capitel abutment 17° | $Ø$ 4.80Height 1 to 2 mm |
| GNCAPNA 304801H | Microdent Genius Hex AngledMini Capitel abutment 30° | $Ø$ 4.80Height 1 to 2 mm |
| UTSNPC4X | Microdent Genius Mini Capitelcementable coping | $Ø$ 4.80 |
| UTSNCP4X | Microdent Genius Mini CapitelProtective Cap | $Ø$ 4.80 |
{7}------------------------------------------------
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 Healingabutment | $Ø$ 4.50Height 1 to 6 mm |
|---|---|---|
| GNPR5001 | Microdent Genius Healingabutment | $Ø$ 5.00Height 1 to 6 mm |
| GNPR5501 | Microdent Genius Healingabutment | $Ø$ 5.50Height 1 to 6 mm |
| GNPCR3501 | Microdent Genius Healingabutment | $Ø$ 3.50Height 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<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.Image: implant design | SameImage: 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 implantabutments | ANKYLOS C/XImplant abutments | yes | |
| • 510K | NA | K083805 | ||
| • intended use/indications for use | Microdent Genius Implant System isindicated for surgical placement in theupper or lower jaw arches, for single-stageor two-stage surgical procedures andcemented, screw retained restorations oroverdentures. Microdent Genius ImplantSystem is intended for immediateplacement and function on single toothand/or multiple tooth applications whengood primary stability is achieved, withappropriate occlusal loading, in order torestore chewing function.Small diameter implants are indicated onlyfor replacement of central and lateral | The ANKYLOS® C/X ImplantSystem is for single-stage ortwo-stage surgical proceduresand cemented or screwretained restorations. TheANKYLOS® C/XImplant System is intended forimmediate placement andfunction on single tooth and/ormultiple tooth applicationswhen good primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function. | Yes (GeniusMicrodentspecified the useof smalldiameterimplants) | |
| incisors in the maxillar and mandible. | Multiple tooth applications maybe 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 CoverScrew | ANKYLOS CoverScrew | yes |
| ● | 510K | NA | K083805 | |
| ● | intended use/indications for use | Microdent Genius Implant System isindicated for surgical placement in theupper or lower jaw arches, for single-stageor two-stage surgical procedures andcemented, screw retained restorations oroverdentures. Microdent Genius ImplantSystem is intended for immediateplacement and function on single toothand/or multiple tooth applications whengood primary stability is achieved, withappropriate occlusal loading, in order torestore chewing function.Small diameter implants are indicated onlyfor replacement of central and lateralincisors in the maxillar and mandible. | The ANKYLOS® C/X ImplantSystem is for single-stage ortwo-stage surgical proceduresand cemented or screwretained restorations. TheANKYLOS® C/XImplant System is intended forimmediate placement andfunction on single tooth and/ormultiple tooth applicationswhen good primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Multiple tooth applications maybe splinted with a bar. | Yes (GeniusMicrodentspecified the useof smalldiameterimplants |
| ● | design; | One diameter and metricthread M1.8 | One diameter andmetric thread M1.8 | yes |
| ● | Collar Height (mm,min -max) | Without heights | Without heights | yes |
| ● | Seating Surface(mm) | Diameter 2.9 mm. | Diameter2.48 mm. | yes |
| ● | connection type | Internal connection tapered. | Internal connectiontapered. | yes |
| ● | sterilization | Sterile (Gamma irradiation) | same | Yes.Packaged sterilewith the implant |
| ● | Device Name | Microdent Genius | AnkylosRegular | yes |
| Healing Abutment | C/XGingiva | |||
| Former | ||||
| ● | 210K | NA | K083805 | |
| ● | intended use/ | Yes(Genius | ||
| indications for use | Microdent Genius Implant Systemis | 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 | ofsmall | ||
| or two-stage surgical procedures and | and cemented orscrew | diameter | ||
| cemented, screw retained restorations or | retained restorations.The | implants | ||
| overdentures. Microdent Genius Implant | ANKYLOS® C/X | |||
| Systemisintendedfor immediateplacement and function on single tooth | Implant System is intended forimmediate placementand | |||
| and/or multiple tooth applications when | function on single tooth and/or | |||
| good primary stability is achieved, with | applicationsmultipletooth | |||
| 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.restorechewing | |||
| incisors in the maxillar and mandible. | Multiple tooth applications may | |||
| be splinted with a bar. | ||||
| ● | design; | diameters3andmetric | 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 |
| taperedwith | ||||
| indexation (/X) or | ||||
| Device Name | Microdent Genius | only tapered (C/)AnkylosFixation | ||
| ● | Retention screw | screw | yes | |
| ● | 210K | NA | K083805 | |
| ● | intended use/ | (GeniusYes | ||
| 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 | ofsmall | ||
| or two-stage surgical procedures and | and cementedorscrew | diameter | ||
| cemented, screw retained restorations or | retained restorations.The | implants | ||
| overdentures. Microdent Genius Implant | ANKYLOS® C/X |
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| System is intended for immediateplacement and function on single toothand/or multiple tooth applications whengood primary stability is achieved, withappropriate occlusal loading, in order torestore chewing function.Small diameter implants are indicated onlyfor replacement of central and lateralincisors in the maxillar and mandible. | Implant System is intended forimmediate placement andfunction on single tooth and/ormultiple tooth applicationswhen good primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Multiple tooth applications maybe splinted with a bar. | |||
|---|---|---|---|---|
| • | design; | This screw havinga threaded fuse and a headwith a hexagon 1.20 mmflat to flat. | Similar geometry with hexagon 1.00 mm. | yes |
| • | Seating Surface(mm) | This is a single Retentionscrew for all platforms | same | yes |
| • | Device Name | Microdent Genius Conicalabutment | Ankylos RegularC/X abutment andAnkylos SynCone C/ | yes |
| • | 510K | NA | K083805K041509 | |
| • | intended use/indications for use | Microdent Genius Implant System isindicated for surgical placement in theupper or lower jaw arches, for single-stageor two-stage surgical procedures andcemented, screw retained restorations oroverdentures. Microdent Genius ImplantSystem is intended for immediateplacement and function on single toothand/or multiple tooth applications whengood primary stability is achieved, withappropriate occlusal loading, in order torestore chewing function.Small diameter implants are indicated onlyfor replacement of central and lateralincisors in the maxillar and mandible. | The ANKYLOS® C/X ImplantSystem is for single-stage ortwo-stage surgical proceduresand cemented or screwretained restorations. TheANKYLOS® C/XImplant System is intended forimmediate placement andfunction on single tooth and/ormultiple tooth applicationswhen good primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Multiple tooth applications maybe splinted with a bar. | Yes (GeniusMicrodentspecified the useof smalldiameterimplants |
| • | design; | 3 diameters and sameconnection (MicrodentGenius) | One diameter andAnkylosconnection | yes |
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| min -max) | mm | |||
|---|---|---|---|---|
| ● | Seating Surface(mm) | Diameter from 4.5, 5 and5.5 mm. | Diameter5.5 mm. | yes |
| ● | connection type | Internal connection taperedwith indexation (H) or onlytapered (C). | Internal connectiontapered withindexation (/X) oronly tapered (C/) | yes |
| ● | Device Name | Microdent Genius Angledabutment | Ankylos RegularC/X abutment | yes |
| ● | 510K | NA | K083805 | |
| ● | intended use/indications for use | Microdent Genius Implant System isindicated for surgical placement in theupper or lower jaw arches, for single-stageor two-stage surgical procedures andcemented, screw retained restorations oroverdentures. Microdent Genius ImplantSystem is intended for immediateplacement and function on single toothand/or multiple tooth applications whengood primary stability is achieved, withappropriate occlusal loading, in order torestore chewing function.Small diameter implants are indicated onlyfor replacement of central and lateralincisors in the maxillar and mandible. | The ANKYLOS® C/X ImplantSystem is for single-stage ortwo-stage surgical proceduresand cemented or screwretained restorations. TheANKYLOS® C/XImplant System is intended forimmediate placement andfunction on single tooth and/ormultiple tooth applicationswhen good primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Multiple tooth applications maybe splinted with a bar. | Yes (GeniusMicrodentspecified the useof smalldiameterimplants |
| ● | design; | 3 diameters and sameconnection (MicrodentGenius).3 angulations 15°, 20° and25°.With flap (aesthetics) andwithout flap. | One diameter andAnkylosconnection.5 angulations 7.5°,15°, 22.5°, 30° and37.5°.With flap. | YesWithout flapprovides shoulderprosthesisoccultation incases of lowgingiva. |
| ● | Collar Height (mm,min -max) | 1 mm to 5 mm | 0.75, 1.5, 3 and 4,5mm | yes |
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| • | 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 |
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| Seating Surface●(mm) | Diameter | Diameter | yes |
|---|---|---|---|
| 4.8 mm. | 4.2 mm. | ||
| connection type● | Internal connection tapered(C). | Internal connectiontapered (C/) | yes |
| Copings● | Cementable copingofTitanium (Grade 5) | cementableTwocopingof Goldalloy. | yes |
| Device Name● | Microdent Genius Ossciliaretention abutment | XiVEBall andSocket AbutmentAnkylosSnapabutment C/. | yes |
| 510K● | NA | K021318K083805 | |
| intended use/●indications for use | Microdent Genius Implant Systemindicated for surgical placement in theupper or lower jaw arches, for single-stageor two-stage surgical procedures andcemented, screw retained restorations oroverdentures. Microdent Genius Implantisfor immediateSystemintendedplacement and function on single toothand/or multiple tooth applications whengood primary stability is achieved, withappropriate occlusal loading, in order torestore chewing function.Small diameter implants are indicated onlyfor replacement of central and lateralincisors in the maxillar and mandible. | The XiVE@ Dental ImplantSystem is indicated as follows:once the implant hasosseointegrated, it serves tosupport single tooth, bridgeand overdenture restorations.In the edentulous mandible, aminimum of four XiVE dentalimplants (>9.5mm length) areplaced between the mentalforamina and rigidly splintedtogether.lmthiscase,bar-prostheticloadingisafterpossibleimmediatelyimplant placement.The ANKYLOS® C/X ImplantSystem is for single-stage ortwo-stage surgical proceduresscrewandcemented orretained restorations. TheANKYLOS® C/XSystem is intendedImplantfor immediate placement andfunction on single tooth and/ormultipletooth applicationswhen good primary stability iswith appropriateachieved, | Yes (but GeniusMicrodentspecified the useofsmalldiameterimplants.Theuse of XiVE@DentalImplantSysteminmandiblerestrictedದof ofminimumXiVEfourdental implants(>9.5mm length)placedarebetweenthementalforamina). |
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| occlusal loading, in order torestore chewing function.Multiple tooth applications maybe splinted with a bar. | |||
|---|---|---|---|
| • design; | One prosthetic diameter of3.5 mm.Compensation 17°. | One prosthetic diameter of 3.1 mm. Compensation 20°. | YesXiVE 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
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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.
§ 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.