(151 days)
Microdent Ektos 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 Ektos 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 maxilla and mandible.
Microdent Ektos Implant System is comprised of dental implants and prosthetic components. Microdent Ektos dental implants are internal connection endosseous implants machined in titanium that can be used with deferred load or immediate load techniques. The implant is designed to be inserted at crestal level. Microdent Ektos Implant is recommended to be placed at crestal bone level. The implant has an internal hexagonal connection. Microdent Ektos Implants are provided with blasted surface. The implants are supplied sterile and the abutments are provided non-sterile. The system also contains Microdent Ektos abutments made of Ti-6AL 4-V-ELI alloy. The abutments Conical, Multi-function (supplied with the implant) and Mini Capitel are used for cemented and screw-retained restorations. The following Cover Screws are provided to protect the inner configuration of the implant and are 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.
The provided text describes the Microdent Ektos Implant System, a dental implant device, and its comparison to predicate devices to establish substantial equivalence for regulatory approval. The document outlines acceptance criteria related to design, materials, sterilization, and performance, primarily through adherence to ISO standards and bench testing.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" against "reported device performance" in a quantitative sense as might be expected for an AI device. Instead, it describes compliance with recognized standards and successful bench testing. The acceptance criteria for the Microdent Ektos Implant System are largely based on demonstrating substantial equivalence to predicate devices (Legacy System Dental Implants – K073033 and Microdent Genius Implant System – K141188) and compliance with specific ISO standards. The "reported device performance" is the confirmation that these standards have been met through non-clinical testing.
| Acceptance Criteria (based on standards/benchmarking) | Reported Device Performance (Summary of results) |
|---|---|
| Material Composition: | |
| - Unalloyed titanium (ISO 5832-2:1999) | Successfully manufactured with commercially pure titanium (grade 4). |
| - Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:1996) | Abutments made of Ti-6AL 4-V-ELI alloy. |
| Risk Management: | |
| - Application of risk management (ISO 14971:2007) | Design and manufacturing in accordance with this standard. |
| Dynamic Fatigue Testing: | |
| - Endosseous dental implants (ISO 14801:2007) | Static and dynamic fatigue testing performed, fulfilling design and performance requirements. |
| Biological Evaluation: | |
| - Evaluation and testing (ISO 10993-1:2009) | Biocompatibility evaluation performed, leveraging data from Microdent Genius. |
| - In Vitro cytotoxicity (ISO 10993-5:2009) | Cytotoxicity testing performed, leveraging data from Microdent Genius. |
| - Bacterial Endotoxins Test (USP 37th ed. <85>) | LAL test performed, leveraging data from Microdent Genius. |
| - Pyrogen Test (USP 37th ed. <151>) | Pyrogen testing performed, leveraging data from Microdent Genius. |
| Sterilization Validation: | |
| - Requirements for development, validation (ISO 11137-1:2006/(R)2010; ISO 11137-2:2012) | Sterilization validation performed following these standards. Device is supplied sterile (Gamma irradiation). |
| Packaging & Shelf Life: | |
| - Packaging requirements (ISO 11607-1:2006/(R)2010; ISO 11607-2:2006/(R)2010) | Package integrity testing in accordance with ASTM F-1980-07. Shelf life of 5 years. |
| Surface Analysis: | |
| - Surface finish and roughness (ESEM analyses) | ESEM analyses performed to determine adequate surface finish and roughness. Blasted surface achieved 0.82 μm peak-to-valley roughness. |
| - Surface cleaning (EDS and TOC analyses) | EDS and TOC analyses performed to determine adequate surface cleaning. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document focuses on non-clinical bench testing. It does not provide information about a "test set" in the context of clinical data or its provenance. For fatigue testing, multiple samples (implants) would be tested to ISO 14801, but the exact sample sizes are not specified for each test. The testing was performed by Implant Microdent Systems, located in Spain.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is a physical dental implant system, not an AI or diagnostic device that requires expert-established ground truth for a test set. The "ground truth" here is defined by engineering standards and material science, not clinical expert consensus on diagnostic outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for clinical studies, especially those involving human interpretation or expert review, which were not part of this submission.
5. 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
Not applicable. This is not an AI device, and no MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI device or software algorithm. Performance was evaluated through non-clinical bench testing, which is 'standalone' in the sense of the device itself being tested, but not in the context of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance, as demonstrated in this submission, is based on:
- Engineering standards: Primarily ISO standards (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility, ISO 11137 for sterilization).
- Material specifications: Compliance with recognized material standards like ISO 5832-2 and ISO 5832-3.
- Benchmarking equivalence: Demonstrating that the device's characteristics and performance are substantially equivalent to already legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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 stylized caduceus symbol, which features three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
Implants Microdent System S.L Mr. Jordi Clapés Donadeu Quality Director C/ Carles Buigas, I-Can Magre Santa Eulalia de Roncana, Barcelona 08187 SPAIN
Re: K153650
Trade/Device Name: Microdent Ektos Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 11, 2016 Received: April 18, 2016
Dear Mr. Donadeu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 ਦੇ
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) K153650
Device Name Microdent Ektos Implant System
Indications for Use (Describe)
Microdent Ektos 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 Ektos 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 maxilla 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:
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"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 Bervices (301) 443-6740 EF
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Image /page/3/Picture/0 description: The image contains a logo for Microdent Implant System. The logo features the letters "MD" inside a circle with three curved lines extending to the right, resembling sound waves. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, with the words "IMPLANT SYSTEM" in a smaller font size underneath.
510(k) SUMMARY (21 CFR 807.92)
This 510(k) summary is 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 RonçanaE-08187 Barcelona, CataloniaSpain |
| Telephone: | +34-902-402-420 |
|---|---|
| Fax Number: | +34-94-844-7893 |
| Contact Person: | Jordi Clapes Donadeu |
| Date Prepared: | May 9th, 2016 |
- B. Device
| Trade Name: | Microdent Ektos Implant System |
|---|---|
| Classification Name: | Endosseous Dental Implants |
| Product Code: | DZE and NHA (DZE is considered the primary product code) |
| Class: | II |
| Regulation Number: | 21 CFR 872.3640 |
C. Identification of Legally Marketed Predicate Device
Legacy System Dental Implants – K073033 (primary predicate) Microdent Genius Implant System – K141188 (reference predicate) Legacy Abutment System – K060063 (reference predicate)
D. Description of the Device
Microdent Ektos Implant System is comprised of dental implants and prosthetic components. Microdent Ektos dental implants are internal connection endosseous implants machined in titanium that can be used with deferred load or immediate load techniques. The implant is designed to be inserted at crestal level. Microdent Ektos Implant is recommended to be placed at crestal bone level.
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Image /page/4/Picture/1 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with a series of curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, and below that, the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
The implant has an internal hexagonal connection.
Microdent Ektos Implants are provided with blasted surface.
The implants are supplied sterile and the abutments are provided non-sterile.
- Implants are provided in the following diameters and length.
| Ø platform | Ø core | Length | Reference |
|---|---|---|---|
| 3.50 | 3.70 | 8 | EK3708CP |
| 10 | EK3710CP | ||
| 12 | EK3712CP | ||
| 14 | EK3714CP | ||
| 16 | EK3716CP | ||
| 18 | EK3718CP | ||
| 3.50 | 4.20 | 8 | EK4208CP |
| 10 | EK4210CP | ||
| 12 | EK4212CP | ||
| 14 | EK4214CP | ||
| 16 | EK4216CP | ||
| 18 | EK4218CP | ||
| 4.50 | 4.80 | 8 | EK4808CP |
| 10 | EK4810CP | ||
| 12 | EK4812CP | ||
| 14 | EK4814CP | ||
| 16 | EK4816CP | ||
| 18 | EK4818CP | ||
| 5.70 | 5.80 | 8 | EK5808CP |
| 10 | EK5810CP | ||
| 12 | EK5812CP | ||
| 14 | EK5814CP | ||
| 16 | EK5816CP |
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Image /page/5/Picture/1 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with three curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, and below that, the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
- . The system also contains Microdent Ektos abutments made of Ti-6AL 4-V-ELI alloy as follows:
The abutments Conical, Multi-function (supplied with the implant) and Mini Capitel are used for cemented and screw-retained restorations.
Conical abutment with flap as indicated in the following table:
| EKPCCP3501H | Microdent Ektos hex. Conicalwith flap abutment | Plat. Ø 3.50Height 1, 3 and 5 mm |
|---|---|---|
| EKPCCP4501H | Microdent Ektos hex. Conicalwith flap abutment | Plat. Ø 4.50Height 1, 3 and 5 mm |
| EKPCCP5701H | Microdent Ektos hex. Conicalwith flap abutment | Plat. Ø 5.70Height 1 mm |
| EKPCCP3501R | Microdent Ektos CircularConical with flap abutment | Plat. Ø 3.50Height 1, 3 and 5 mm |
| EKNPCCP4501R | Microdent Ektos CircularConical with flap abutment | Plat. Ø 4.50Height 1, 3 and 5 mm |
| EKPCCP5701R | Microdent Ektos CircularConical with flap abutment | Plat. Ø 5.70Height 1 mm |
Conical abutment without flap as indicated in the following table:
| EKPCSP3500H | Microdent Ektos Hex. Conicalwithout flap abutment | Plat. Ø 3.50Height 0 to 5 mm |
|---|---|---|
| EKPCSP4500H | Microdent Ektos Hex. Conicalwithout flap abutment | Plat. Ø 4.50Height 0 to 5 mm |
| EKPCSP5700H | Microdent Ektos Hex. Conicalwithout flap abutment | Plat. Ø 5.70Height 0 and 1 mm |
| EKPCSP3500R | Microdent Ektos CircularConical without flap abutment | Plat. Ø 3.50Height 0 to 5 mm |
| EKPCSP4500R | Microdent Ektos CircularConical without flap abutment | Plat. Ø 4.50Height 0 to 5 mm |
| EKPCSP5700R | Microdent Ektos CircularConical without flap abutment | Plat. Ø 5.70Height 0 and 1 mm |
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Image /page/6/Picture/1 description: The image contains a logo for Microdent Implant System. The logo features the letters "MD" inside a blue circle, with a series of curved lines emanating from the right side of the circle, resembling sound waves. Below the circle, the word "MICRODENT" is written in a bold, dark blue font, and below that, the words "IMPLANT SYSTEM" are written in a smaller, lighter blue font.
| EKPC13500H | Microdent Ektos hex. immediateloading conical abutment | Plat. Ø 3.50Height 0 mm |
|---|---|---|
| EKPC4500H | Microdent Ektos hex. immediateloading conical abutment | Plat. Ø 4.50Height 0 mm |
| EKPC15700H | Microdent Ektos hex. immediateloading conical abutment | Plat. Ø 5.70Height 0 mm |
| EKPC13500R | Microdent Ektos Circularimmediate loading conicalabutment | Plat. Ø 3.50Height 0 mm |
| EKPC4500R | Microdent Ektos Circularimmediate loading conicalabutment | Plat. Ø 4.50Height 0 mm |
| EKPC15700R | Microdent Ektos Circularimmediate loading conicalabutment | Plat. Ø 5.70Height 0 mm |
Immediate loading conical abutments as indicated in the following table:
Mini Capitel abutment as indicated in the following table:
| EKCAPN3501R | Microdent Ektos Circular MiniCapitel Abutment | Plat. Ø 3.50Height 1 to 4 mm |
|---|---|---|
| EKCAPN4501R | Microdent Ektos Circular MiniCapitel Abutment | Plat. Ø 4.50Height 1 to 4 mm |
| EKCAPN5701R | Microdent Ektos Circular MiniCapitel Abutment | Plat. Ø 5.70Height 1 to 2 mm |
| UTSNPC4X | Microdent Ektos Mini Capitelcementable coping | Ø 4.80 |
| UTSNPC51 | Microdent Ektos Mini Capitelcementable coping | Ø 5.60 |
| UTSNCP4X | Microdent Ektos Mini CapitelProtective Cap | Ø 4.80 |
| UTSNCP51 | Microdent Ektos Mini CapitelProtective Cap | Ø 5.60 |
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Image /page/7/Picture/1 description: The image contains the logo for Microdent Implant System. The logo features the letters "MD" inside of a circle with three curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, dark blue font. Underneath "MICRODENT", the words "IMPLANT SYSTEM" are written in a smaller, less bold font.
- The following Cover Screws are provided to protect the inner configuration of the implant and are supplied sterile with the implant.
| EKTC35 | Microdent Ektos cover screw | Plat. Ø 3.50 |
|---|---|---|
| EKTC45 | Microdent Ektos cover screw | Plat. Ø 4.50 |
| EKTC57 | Microdent Ektos cover screw | Plat. Ø 5.70 |
- Healing abutment to shape the soft tissue during the healing phase as indicated in the following table:
| EKPR3502 | Microdent Ektos Healingabutment | Ø 4.50Height 2 to 5 mm |
|---|---|---|
| EKPR4502 | Microdent Ektos Healingabutment | Ø 6.50Height 2 mm |
| EKPR5702 | Microdent Ektos Healingabutment | Ø 5.50Height 1 to 6 mm |
| EKPCR3502 | Microdent Ektos Healingabutment | Ø 3.50Height 2 to 5 mm |
| EKPCR4502 | Microdent Ektos Healingabutment | Ø 4.50Height 2 to 5 mm |
| EKPCR5702 | Microdent Ektos Healingabutment | Ø 5.70Height 2 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.
| EKEOSS3500 | Microdent Ektos Ossciliaretention abutment | Ø 3.50Height 0 to 4 mm |
|---|---|---|
| EKEOSS4500 | Microdent Ektos Ossciliaretention abutment | Ø 4.50Height 0 to 4 mm |
| EKEOSS5700 | Microdent Ektos Osscilia | Ø 5.70 |
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Image /page/8/Picture/1 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with three curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font. Below that, the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
| retention abutment | Height 0 to 1 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 Ektos implants. No compatibility with other implant systems is claimed.
E. Intended Use
Microdent Ektos 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 Ektos 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 maxilla 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 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium ISO 5832-3:1996 lmplants 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
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
USP 37t0 ed. 2014<85> Bacterial Endotoxins Test
USP 37th ed. 2014<151> Pyrogen Test
ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments -Biocontamination Control - Part 1: General Principles and Methods
Cleanrooms and Associated Controlled Environments - Part 1: ISO 14644-1:1999 Classification of Air Cleanliness
ISO 14644-3:2005 Cleanrooms and associated controlled environments - Part 3: Test methods
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Image /page/9/Picture/1 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with a series of curved lines emanating from the right side of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font. Underneath "MICRODENT", the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
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 | Own predicate | Predicate Device | SE / Comments | Diameter (mm) | Diameter ranges:3.7 mm, 4.2 mm,4.8 mm, 5.8 mmand 7.00 mm. | Diameter ranges:3.5 mm, 4.5 mm,5.0 and 5.5 mm. | Diameter ranges:3.2 mm, 3.7 mm,4.2 mm, 4.7 mm,5.2 mm, 5.7 mmand 7.0 mm. | Yes |
|---|---|---|---|---|---|---|---|---|---|
| Device | Microdent Ektosimplant | Microdent Geniusimplant ( K141188) | Legacy SystemDental Implants(K073033) | Yes (MicrodentEktos andLegacy have thesame hexconnection.MicrodentGenius hasconnectiontapered withindexation, restof characteristicssame asMicrodentEktos) | Connection type | Internal connection withhex. | Internal connectionwith taperedindexation. | Internal connectionwith hex. | Yes with Legacy(Hexconnection)Differentconnection fromGenius implant |
| Intended | Microdent Ektos Implant | Microdent Genius Implant | The intended use of the | Yes (Microdent | Surface treatment | Blasting(roughness 0,82μmpeak-to-valley). | same | SBM (Soluble BlastMedia) orHA-coated. (SBMroughness 1.5-2.3μm peak-to-valley). | Yes (Blastedtreatment withsimilar result) |
| Sterilization | Sterile (Gammairradiation) | same | same | Yes | |||||
| use | System is indicated forsurgical placement in theupper or lower jaw arches,for single-stage or two-stagesurgical procedures andcemented, screw retainedrestorations oroverdentures. MicrodentEktos Implant System isintended for immediateplacement and function onsingle tooth and/or multipletooth applications whengood primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only forreplacement of central andlateral incisors in themaxilla and mandible. | System is indicated forsurgical placement in theupper or lower jaw arches, forsingle-stage or two-stagesurgical procedures andcemented, screw retainedrestorations or overdentures.Microdent Genius ImplantSystem is intended forimmediate placement andfunction on single tooth and/ormultiple tooth applicationswhen good primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only for replacementof central and lateral incisorsin the maxillar and mandible. | Legacy System Implants withHA Coating is identical to theintended use of the predicateabutments. These implantsare two-piece implants forsingle-stage or two-stagesurgical procedures. TheLegacy implants are intendedfor use in the mandible andmaxilla, in support of single ormultiple-unit cement or screwreceiving fixed restorationsand for retention and supportof overdentures. The implantsare intended for immediateplacement and function forsupport of single tooth and/ormultiple tooth restorations,recognizing bone stability andappropriate occlusal loadrequirements. | Ektos specifiedthe use of smalldiameter implants,Legacy Systemare coatedblasted or HAplasma) | Packaging | Inner sleeve tosuspend theimplant/fixture-mount assemblypackaged insidean outer vialsealed with a cap.Packaging alsoincludes surgicalcover screw andmulti-functionabutment. | Packaged in sterilevial with coverscrew | Inner sleeve tosuspend theimplant/fixture-mount assemblypackaged insidean outer vial sealedwith a cap.Packaging alsoincludes surgicalcover screw,extender andtemporary coping. | Yes (but Legacyincludes anextender) |
| Indication | Delayed orimmediate load | same | same | Yes | Shelf Life | 5 years | same | same | Yes |
| Material | Comercially puretitanium (grade4 as ISO 5832-2) | same | Titanium Alloy(grade 5 as ISO5832-3) | Yes (Differentdegree but withvery similarproperties) | MatingComponents | All MicrodentRestorativeComponents | All MicrodentRestorativeComponents | All LegacyRestorativeComponents | Yes |
| Design; | Threaded, rootform implant.Image: Threaded, root form implant | sameImage: Threaded, root form implant | sameImage: Threaded, root form implant | Yes (Legacyimplant hasquadruple-leadthreads near top)Image: Threaded, root form implant | |||||
| Length (mm) | 8, 10, 12, 14, 16and 18 mm. | 8, 10, 12, 14, 16 and18 mm. | 8, 10, 11.5, 13 and16 mm | Yes | |||||
| Platform | Diameter ranges:3.5 mm, 4.5 mmand 5.7 mm. | Diameter ranges:3.5 mm, 4.5 mm,5.0 and 5.5 mm. | Diameter ranges:3.0 mm, 3.5 mm,4.5 mm and 5.7mm | Yes |
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Image /page/10/Picture/0 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle with three curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, and below that, the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
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Image /page/11/Picture/0 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with a series of curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, and below that, the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
Table 2: General Prosthetic Device Comparison
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Image /page/12/Picture/0 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with three curved lines extending to the right of the circle. The words "MICRODENT" and "IMPLANT SYSTEM" are written in a sans-serif font below the circle. The text and the circle are both blue.
| Characteristic | Subject Device | Own predicate | Predicate Device | SE / Comments |
|---|---|---|---|---|
| Device Name | Microdent Ektosimplant abutments | Microdent Geniusimplant abutments | Legacy AbutmentSystem | yes |
| 510K | NA | K141188 | K060063 | Yes |
| Intended use | Microdent Ektos 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 Ektos 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 maxilla a nd mandible. | 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 Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients. The Legacy Abutment System is compatible with implants that have mating diameters, lead-in bevels, internal hex sizes, and 1-72UNF internal threads, as shown in the Zimmer Dental Tapered Screw-Vent Surgical Manual. Implant Direct LLC will monitor the compatible implants for modifications to ensure future compatibility. In the event of any modification, Implant Direct LLC will either modify the Legacy abutment to ensure compatibility, or cease claiming compatibility to the modified Zimmer Dental Screw-Vent implants. | Yes (Ektos Microdent specified the use of small diameter implants.). |
| Material | Titanium alloy (Grade 5). | same | Titanium alloy. | Yes |
| Surface treatment | Polished. | same | same | Yes |
| Sterilization | Non-sterile | same | same | Yes |
| Packaging | Blister | same | same | Yes |
| Device Name | Microdent Ektoscover screw | Microdent Geniuscover screw | Legacy cover screw | Yes |
|---|---|---|---|---|
| 510K | NA | K141188 | K073033 | Yes |
| Intended use | Microdent Ektos ImplantSystem is indicated forsurgical placement in theupper or lower jaw arches, forsingle-stage or two-stagesurgical procedures andcemented, screw retainedrestorations or overdentures.Microdent Ektos ImplantSystem is intended forimmediate placement andfunction on single tooth and/ormultiple tooth applicationswhen good primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only for replacementof central and lateral incisorsin the maxilla and mandible. | Microdent Genius ImplantSystem is indicated forsurgical placement in theupper or lower jaw arches, forsingle-stage or two-stagesurgical procedures andcemented, screw retainedrestorations oroverdentures. MicrodentGenius Implant System isintended for immediateplacement and function onsingle tooth and/or multipletooth applications whengood primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only forreplacement of central andlateral incisors in themaxillar and mandible. | The intended use of theLegacy System Implants withHA Coating is identical to theintended use of the predicateabutments. These implantsare two-piece implants forsingle-stage or two-stagesurgical procedures. TheLegacy implants are intendedfor use in the mandible andmaxilla, in support of single ormultiple-unit cement or screwreceiving fixed restorationsand for retention and supportof overdentures. The implantsare intended for immediateplacement and function forsupport of single tooth and/ormultiple tooth restorations,recognizing bone stability andappropriate occlusal loadrequirements. | Yes (MicrodentEktos specifiedthe use of smalldiameterimplants,Legacy Systemare coatedblasted or HAplasma) |
| Design; | 3 diameters andmetric thread M1.8 | One diameter | same | Yes (MicrodentGenius has onediameter andsmaller) |
| Collar Height(mm, min-max) | Without heights | same | same | Yes |
| SeatingSurface (mm) | Diameter 3.5 mm,4.5 mm and 5.7mm. | Diameter 2.9 mm. | same | Yes (MicrodentGenius has onediameter andsmaller) |
| Connectiontype | Internal connectiontapered. | Internal connectiontapered. | Yes | |
| Sterilization | Sterile (Gammairradiation) | same | same | Yes.Packagedsterile with theimplant |
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Image /page/13/Picture/0 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with a series of curved lines emanating from the right side of the circle. Below the circle, the word "MICRODENT" is written in a larger, bolder font, and below that, the words "IMPLANT SYSTEM" are written in a smaller font. The text and the circle are all in a blue color.
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Image /page/14/Picture/0 description: The image contains the logo for Microdent Implant System. The logo features the letters "MD" inside of a circle with three curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font. Underneath "MICRODENT", the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
| Device Name | Microdent EktosHealing Abutment | Microdent GeniusHealing Abutment | LegacyCollarHealing | yes | |
|---|---|---|---|---|---|
| 510K | NA | K141188 | K060063 | Yes | |
| Intended use | Microdent Ektos ImplantSystem is indicated forsurgical placement in theupper or lower jaw arches, forsingle-stage or two-stagesurgical procedures andcemented, screw retainedrestorations or overdentures.Microdent Ektos ImplantSystem is intended forimmediate placement andfunction on single tooth and/ormultiple tooth applicationswhen good primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only for replacementof central and lateral incisorsin the maxilla a nd mandible. | Microdent Genius ImplantSystem is indicated forsurgical placement in theupper or lower jaw arches, forsingle-stage or two-stagesurgical procedures andcemented, screw retainedrestorations oroverdentures. MicrodentGenius Implant System isintended for immediateplacement and function onsingle tooth and/or multipletooth applications whengood primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only forreplacement of central andlateral incisors in themaxillar and mandible. | The Legacy Abutment Systemis intended for use with dentalimplants in the maxillaryand/or mandibular arches toprovide support for crowns,bridges, or overdentures foredentulous or partiallyedentulous patients.The Legacy Abutment Systemis compatible with implantsthat have mating diameters,lead-in bevels, internal hexsizes, and 1-72UNF internalthreads, as shown in theZimmer Dental TaperedScrew-Vent Surgical Manual.Implant Direct LLC will monitorthe compatible implants formodifications to ensure futurecompatibility. In the event ofany modification, ImplantDirect LLC will either modifythe Legacy abutment toensure compatibility, or ceaseclaiming compatibility to themodified Zimmer DentalScrew-Vent implants. | Yes (EktosMicrodentspecified theuse of smalldiameterimplants). | |
| Design; | 4 diameters andmetric thread M1.8 | One diameter | One diameter andmetric thread M1.8 | Yes | |
| Collar Height(mm, min-max) | 0 mm to 4 mm | 1 mm to 6 mm | 3 and 5 mm | Yes | |
| SeatingSurface (mm) | Diameter from 3.5,4.5, 5.6 and 6.5mm. | Diameter from4.5, 5 and 5.5 mm. | Diameter from3.7, 4.7, 5.7 and 6.5mm. | Yes | |
| Connection | Internal connection | same | same | Yes | |
| Device Name | Microdent EktosRetention screw | Microdent GeniusRetention screw | Legacyscrew | Fixation | Yes |
| 510K | NA | K141188 | K060063 | Yes | |
| Intended use | Microdent Ektos ImplantSystem is indicated forsurgical placement in theupper or lower jaw arches, forsingle-stage or two-stagesurgical procedures andcemented, screw retainedrestorations or overdentures.Microdent Ektos ImplantSystem is intended forimmediate placement andfunction on single tooth and/ormultiple tooth applicationswhen good primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only for replacementof central and lateral incisorsin the maxilla a nd mandible. | Microdent Genius ImplantSystem is indicated forsurgical placement in theupper or lower jaw arches,for single-stage or two-stagesurgical procedures andcemented, screw retainedrestorations oroverdentures. MicrodentGenius Implant System isintended for immediateplacement and function onsingle tooth and/or multipletooth applications whengood primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only forreplacement of central andlateral incisors in themaxillar and mandible. | The Legacy Abutment Systemis intended for use with dentalimplants in the maxillaryand/or mandibular arches toprovide support for crowns,bridges, or overdentures foredentulous or partiallyedentulous patients.The Legacy Abutment Systemis compatible with implantsthat have mating diameters,lead-in bevels, internal hexsizes, and 1-72UNF internalthreads, as shown in theZimmer Dental TaperedScrew-Vent Surgical Manual.Implant Direct LLC will monitorthe compatible implants formodifications to ensure futurecompatibility. In the event ofany modification, ImplantDirect LLC will either modifythe Legacy abutment toensure compatibility, or ceaseclaiming compatibility to themodified Zimmer DentalScrew-Vent implants. | Yes(EktosMicrodentspecified theuse of smalldiameterimplants). | |
| Design; | This screw havinga threaded fuse anda head with ahexagon 1.20 mmflat to flat. | same | same | Yes | |
| SeatingSurface (mm) | This is a singleRetention screw forall platforms | same | same | Yes | |
| Device Name | Microdent EktosConical abutment | Microdent GeniusConical abutment | Legacystraight abutments | Yes | |
| 510K | NA | K141188 | K060063 | Yes | |
| Intended use | Microdent Ektos ImplantSystem is indicated forsurgical placement in theupper or lower jaw arches, forsingle-stage or two-stagesurgical procedures andcemented, screw retainedrestorations or overdentures.Microdent Ektos ImplantSystem is intended forimmediate placement andfunction on single tooth and/ormultiple tooth applicationswhen good primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only for replacementof central and lateral incisorsin the maxilla a nd mandible. | Microdent Genius ImplantSystem is indicated forsurgical placement in theupper or lower jaw arches,for single-stage or two-stagesurgical procedures andcemented, screw retainedrestorations oroverdentures. MicrodentGenius Implant System isintended for immediateplacement and function onsingle tooth and/or multipletooth applications whengood primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only forreplacement of central andlateral incisors in themaxillar and mandible. | The Legacy Abutment Systemis intended for use with dentalimplants in the maxillaryand/or mandibular arches toprovide support for crowns,bridges, or overdentures foredentulous or partiallyedentulous patients.The Legacy Abutment Systemis compatible with implantsthat have mating diameters,lead-in bevels, internal hexsizes, and 1-72UNF internalthreads, as shown in theZimmer Dental TaperedScrew-Vent Surgical Manual.Implant Direct LLC will monitorthe compatible implants formodifications to ensure futurecompatibility. In the event ofany modification, ImplantDirect LLC will either modifythe Legacy abutment toensure compatibility, or ceaseclaiming compatibility to themodified Zimmer DentalScrew-Vent implants. | Yes (EktosMicrodentspecified theuse of smalldiameterimplants) | |
| Design | 3 diameters andhex connection(Microdent Ektos).Abutment with flapand without flap. | 3 diameters andsame connection(MicrodentGenius).Abutment withflap and withoutflap. | 4 diameters and hexconnection(Legacy).AbutmentsContoured andFull-contoured. | Yes, butMicrodentEktos andLegacy havethe same hexconnection.MicrodentGenius hasconnectiontapered with | |
| Microdent Ektosinmediate loadingabutment with slotson outer tapersurface. | Microdent Geniusinmediate loadingabutment with slotson outertaper surface. | Design forinmediate loadingis called TitaniumTemporaryAbutments andhave not slots ontaper surface. | indexation, restofcharacteristicssame toMicrodentEktos. | ||
| Multifunctionabutment. | Not available. | Fixture-Mount. | Yes, butFixture-Mounthas the samefunction thanmultifunctionabutmentusing twopieces. | ||
| Collar Height(mm, min-max) | 1 mm to 5 mm | 1 mm to 6 mm | 1, 2 and 3 mm | Yes (Legacyhas not height4 and 5 mm,but Genius yes) | |
| SeatingSurface (mm) | Diameter from 4.5,5.6 and 6.2 mm. | Diameter from4.5, 5 and 5.5 mm. | Diameter from 3.7,4.7, 5.7 and 6.5mm. | Yes | |
| Connectiontype | Internal hexconnection (H) orcircular (R). | Internalconnectiontapered withindexation (H) oronly tapered (R). | Internal hexconnection(Engaging) orNon-Engaging. | YesMicrodentEktos andLegacy havethe same hexconnection.MicrodentGenius hasconnectiontapered withindexation, restofcharacteristicssame toMicrodentEktos | |
| Device Name | Microdent EktosMini Capitelabutment | Microdent GeniusMini Capitelabutment | LegacyScrew-ReceivingOverdentureAbutments | Yes | |
| 510K | NA | K141188 | K060063 | Yes | |
| Intended use | Microdent Ektos ImplantSystem is indicated forsurgical placement in theupper or lower jaw arches, forsingle-stage or two-stagesurgical procedures andcemented, screw retainedrestorations or overdentures.Microdent Ektos ImplantSystem is intended forimmediate placement andfunction on single tooth and/ormultiple tooth applicationswhen good primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only for replacementof central and lateral incisorsin the maxilla a nd mandible. | Microdent Genius ImplantSystem is indicated forsurgical placement in theupper or lower jaw arches, forsingle-stage or two-stagesurgical procedures andcemented, screw retainedrestorations oroverdentures. MicrodentGenius Implant System isintended for immediateplacement and function onsingle tooth and/or multipletooth applications whengood primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only forreplacement of central andlateral incisors in themaxillar and mandible. | The Legacy Abutment Systemis intended for use with dentalimplants in the maxillaryand/or mandibular arches toprovide support for crowns,bridges, or overdentures foredentulous or partiallyedentulous patients.The Legacy Abutment Systemis compatible with implantsthat have matingdiameters,lead-in bevels,internal hex sizes, and1-72UNF internal threads, asshown in the Zimmer DentalTapered Screw-Vent SurgicalManual.Implant Direct LLC will monitorthe compatible implants formodifications to ensure futurecompatibility. In the event ofany modification, ImplantDirect LLC will either modifythe Legacy abutment toensure compatibility, or ceaseclaiming compatibility to themodified Zimmer DentalScrew-Vent implants. | Yes (EktosMicrodentspecified theuse of smalldiameterimplants.) | |
| Design | One prostheticdiameter of 4,8mm. | One prostheticdiameter of 4,8mm. | One prostheticdiameter of 5 mm. | Yes | |
| Collar Height(mm, min) | 1 mm to 4 mm | 1 mm to 6 mm | 1 , 2 and 4 mm | Yes | |
| -max) | |||||
| SeatingSurface (mm) | Diameter ranges:3.5 mm, 4.5 mmand 5.7 mm. | Diameter ranges:3.5 mm, 4.5 mm,5.0 and 5,5 mm. | Diameter ranges:3.0, 3.5 mm, 4.5mm and 5.7 mm. | Yes | |
| Connectiontype | Internal connectiontapered (R). | Internalconnectiontapered (R). | Internal connectiontapered(Non-engaging) | Yes (TheseEktosabutments areused only formultiple screwprosthesis) | |
| Copings | Cementable copingof Titanium (Grade5). | Cementablecoping ofTitanium (Grade5) | Two cementablecoping of Gold andtitanium.Plastic coping.Gold&PlasticCoping.TitaniumTemporary Coping. | Yes (Legacyhas morecomponents) | |
| Device Name | Microdent EktosOsscilia retentionabutment | Microdent GeniusOsscilia retentionabutment | LegacyAbutments | Ball | Yes |
| 510K | NA | K141188 | K060063 | Yes | |
| Intended use | Microdent Ektos ImplantSystem is indicated forsurgical placement in theupper or lower jaw arches, forsingle-stage or two-stagesurgical procedures andcemented, screw retainedrestorations or overdentures.Microdent Ektos ImplantSystem is intended forimmediate placement andfunction on single tooth and/ormultiple tooth applicationswhen good primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only for replacementof central and lateral incisorsin the maxilla a nd mandible. | Microdent Genius ImplantSystem is indicated forsurgical placement in theupper or lower jaw arches, forsingle-stage or two-stagesurgical procedures andcemented, screw retainedrestorations oroverdentures. MicrodentGenius Implant System isintended for immediateplacement and function onsingle tooth and/or multipletooth applications whengood primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Small diameter implants areindicated only forreplacement of central andlateral incisors in themaxillar and mandible. | The Legacy Abutment Systemis intended for use with dentalimplants in the maxillaryand/or mandibular arches toprovide support for crowns,bridges, or overdentures foredentulous or partiallyedentulous patients.The Legacy Abutment Systemis compatible with implantsthat have matingdiameters,lead-in bevels,internal hex sizes, and1-72UNF internal threads, asshown in the Zimmer DentalTapered Screw-Vent SurgicalManual.Implant Direct LLC will monitorthe compatible implants formodifications to ensure futurecompatibility. In the event ofany modification, ImplantDirect LLC will either modifythe Legacy abutment toensure compatibility, or ceaseclaiming compatibility to themodified Zimmer DentalScrew-Vent implants. | Yes(EktosMicrodentspecified theuse of smalldiameterimplants.) | |
| Design; | Diameter ranges:3.5 mm, 4.5 mmand 5.7 mm.Compensation 17°. | One prostheticdiameter of 3.5mm.Compensation17°. | Diameter ranges:3.5 mm, 4.5 mmand 5.7 mm.Compensation 28°. | Yes | |
| Retention: | Three types ofretainers (with | Three types ofretainers (with | Housing and a type | Yes | |
| dimensionalvariations) variesthe cap retainer. | dimensionalvariations) variesthe cap retainer. | of retainer. | (MicrodentGenius andEktos have 3retainers withdifferentfriction andLegacy onlyone.) | ||
| Image: cap retainer | Image: cap retainer | Image: retainers | |||
| Image: retainers | Image: retainers | ||||
| Collar Height(mm, min-max) | 0 mm to 4 mm | 1 mm to 6 mm | 2 and 4 mm. | Yes | |
| SeatingSurface (mm) | Diameters 3.5 mm,4.5 mm and 5.7 mm. | Diameter 3.5 mm. | Diameters 3.5 mm,4.5 mm and 5.7 mm. | Yes | |
| Connectiontype | Internal connectiontapered. | Internalconnectiontapered. | Internal connectiontapered. | Yes |
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Image /page/15/Picture/0 description: The image shows the text "510(k) Premarket Notification – Microdent Ektos Implant System". The text is in a simple sans-serif font and is left-aligned. The text appears to be a title or heading for a document or presentation.
Image /page/15/Picture/1 description: The image contains a logo for Microdent Implant System. The logo features the letters "MD" inside a circle with three curved lines extending to the right, suggesting sound waves or a technological element. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, with the words "IMPLANT SYSTEM" in a smaller font size underneath.
type
tapered.
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Image /page/16/Picture/0 description: The image contains the logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with a series of curved lines emanating from the right side of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, and below that, the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
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Image /page/17/Picture/0 description: The image contains a logo for Microdent Implant System. The logo features the letters "MD" inside a circle, with a series of curved lines emanating from the right side of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, with the words "IMPLANT SYSTEM" written in a smaller font size below it. The text and the circle are all in a blue color.
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Image /page/18/Picture/0 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle with three curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font. Below that, the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font. The text and the circle are all in a blue color.
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Image /page/19/Picture/0 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle with three curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, dark blue font. Underneath "MICRODENT", the words "IMPLANT SYSTEM" are written in a smaller, less bold font.
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Image /page/20/Picture/0 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with a series of curved lines emanating from the right side of the circle. Below the circle, the word "MICRODENT" is written in a large, bold font, and below that, the words "IMPLANT SYSTEM" are written in a smaller font. The logo is primarily blue and white.
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Image /page/21/Picture/0 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle with three curved lines extending to the right, resembling sound waves. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, with the words "IMPLANT SYSTEM" written in a smaller font size directly underneath.
Microdent Ektos Implant System is substantially equivalent intended use as the identified predicates. Microdent Ektos 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 Ektos 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 with Legacy and the connection type with Genius.
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.
Specific performance testing on the EKTOS implant system included:
- . Static and dynamic fatigue testing in accordance with ISO 14801;
- Sterilization validation has been performed following standards ISO 11137-1 and ISO 11137-2.
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Image /page/22/Picture/1 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with a series of curved lines extending to the right of the circle. The text "MICRODENT" is written in a larger font size below the circle, and the text "IMPLANT SYSTEM" is written in a smaller font size below "MICRODENT."
Test data from the predicate device Microdent GENIUS implant system was leveraged for the following performance tests based on the use of identical implant and packaging materials as well as identical manufacturing, packaging and cleaning processes for the Microdent EKTOS implant system:
- . Biocompatibility evaluation in accordance with ISO 10993-1 and specifically cytotoxicity testing in accordance with ISO 10993-5;
- Package integrity testing in accordance with ASTM F-1980-07;
- Pyrogen testing in accordance with USP <151>
- . Bacterial endotoxin LAL test USP <85>
- ESEM analyses to determine adequate surface finish and roughness
- EDS analyses to determine adequate surface cleaning
- TOC analyses to determine adequate surface cleaning
All specific non-clinical testing demonstrated that the Microdent EKTOS implant system fulfills the related requirements. In addition, all leveraged non-clinical testing demonstrated that materials and processes identical to those used for the Microdent EKTOS implant system fulfilled the related requirements.
G. Clinical Testing
No clinical testing was performed. Non-clinical testing was used to support the determination of substantial equivalence.
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.