(151 days)
No
The summary describes a standard dental implant system and its components. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are focused on mechanical and material properties, not algorithmic performance.
Yes.
The device is a dental implant system used to restore chewing function, which is a therapeutic purpose.
No
This device, the Microdent Ektos Implant System, is a dental implant system designed for surgical placement and restoration of chewing function. Its purpose is therapeutic and restorative, not diagnostic.
No
The device description explicitly states that the Microdent Ektos Implant System is comprised of dental implants and prosthetic components, which are physical hardware devices made of titanium and other materials.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for restoring chewing function by being placed in the jaw. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The description details physical components like implants, abutments, screws, and sockets, all designed for surgical implantation and mechanical function. There is no mention of reagents, calibrators, controls, or any components used to examine specimens from the human body in vitro.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a medical device, specifically a dental implant system, used for surgical and restorative purposes.
N/A
Intended Use / Indications for 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 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.
Product codes
DZE, NHA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches, maxilla and mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
- . Bacterial endotoxin LAL test USP
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 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.
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 (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
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) 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:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"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 Magre |
| Sta Eulalia de Ronçana | |
| E-08187 Barcelona, Catalonia | |
| Spain |
| 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 |
5
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. Conical
with flap abutment | Plat. Ø 3.50
Height 1, 3 and 5 mm |
|--------------|--------------------------------------------------------|--------------------------------------|
| EKPCCP4501H | Microdent Ektos hex. Conical
with flap abutment | Plat. Ø 4.50
Height 1, 3 and 5 mm |
| EKPCCP5701H | Microdent Ektos hex. Conical
with flap abutment | Plat. Ø 5.70
Height 1 mm |
| EKPCCP3501R | Microdent Ektos Circular
Conical with flap abutment | Plat. Ø 3.50
Height 1, 3 and 5 mm |
| EKNPCCP4501R | Microdent Ektos Circular
Conical with flap abutment | Plat. Ø 4.50
Height 1, 3 and 5 mm |
| EKPCCP5701R | Microdent Ektos Circular
Conical with flap abutment | Plat. Ø 5.70
Height 1 mm |
Conical abutment without flap as indicated in the following table:
| EKPCSP3500H | Microdent Ektos Hex. Conical
without flap abutment | Plat. Ø 3.50
Height 0 to 5 mm |
|-------------|-----------------------------------------------------------|-----------------------------------|
| EKPCSP4500H | Microdent Ektos Hex. Conical
without flap abutment | Plat. Ø 4.50
Height 0 to 5 mm |
| EKPCSP5700H | Microdent Ektos Hex. Conical
without flap abutment | Plat. Ø 5.70
Height 0 and 1 mm |
| EKPCSP3500R | Microdent Ektos Circular
Conical without flap abutment | Plat. Ø 3.50
Height 0 to 5 mm |
| EKPCSP4500R | Microdent Ektos Circular
Conical without flap abutment | Plat. Ø 4.50
Height 0 to 5 mm |
| EKPCSP5700R | Microdent Ektos Circular
Conical without flap abutment | Plat. Ø 5.70
Height 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. immediate
loading conical abutment | Plat. Ø 3.50
Height 0 mm |
|------------|-------------------------------------------------------------------|-----------------------------|
| EKPC4500H | Microdent Ektos hex. immediate
loading conical abutment | Plat. Ø 4.50
Height 0 mm |
| EKPC15700H | Microdent Ektos hex. immediate
loading conical abutment | Plat. Ø 5.70
Height 0 mm |
| EKPC13500R | Microdent Ektos Circular
immediate loading conical
abutment | Plat. Ø 3.50
Height 0 mm |
| EKPC4500R | Microdent Ektos Circular
immediate loading conical
abutment | Plat. Ø 4.50
Height 0 mm |
| EKPC15700R | Microdent Ektos Circular
immediate loading conical
abutment | Plat. Ø 5.70
Height 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 Mini
Capitel Abutment | Plat. Ø 3.50
Height 1 to 4 mm |
|-------------|---------------------------------------------------|----------------------------------|
| EKCAPN4501R | Microdent Ektos Circular Mini
Capitel Abutment | Plat. Ø 4.50
Height 1 to 4 mm |
| EKCAPN5701R | Microdent Ektos Circular Mini
Capitel Abutment | Plat. Ø 5.70
Height 1 to 2 mm |
| UTSNPC4X | Microdent Ektos Mini Capitel
cementable coping | Ø 4.80 |
| UTSNPC51 | Microdent Ektos Mini Capitel
cementable coping | Ø 5.60 |
| UTSNCP4X | Microdent Ektos Mini Capitel
Protective Cap | Ø 4.80 |
| UTSNCP51 | Microdent Ektos Mini Capitel
Protective 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 Healing
abutment | Ø 4.50
Height 2 to 5 mm |
|-----------|-------------------------------------|----------------------------|
| EKPR4502 | Microdent Ektos Healing
abutment | Ø 6.50
Height 2 mm |
| EKPR5702 | Microdent Ektos Healing
abutment | Ø 5.50
Height 1 to 6 mm |
| EKPCR3502 | Microdent Ektos Healing
abutment | Ø 3.50
Height 2 to 5 mm |
| EKPCR4502 | Microdent Ektos Healing
abutment | Ø 4.50
Height 2 to 5 mm |
| EKPCR5702 | Microdent Ektos Healing
abutment | Ø 5.70
Height 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 Osscilia
retention abutment | Ø 3.50
Height 0 to 4 mm |
|------------|------------------------------------------------|----------------------------|
| EKEOSS4500 | Microdent Ektos Osscilia
retention abutment | Ø 4.50
Height 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 Bacterial Endotoxins Test
USP 37th ed. 2014 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 mm
and 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 mm
and 7.0 mm. | Yes |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Device | Microdent Ektos
implant | Microdent Genius
implant ( K141188) | Legacy System
Dental Implants
(K073033) | Yes (Microdent
Ektos and
Legacy have the
same hex
connection.
Microdent
Genius has
connection
tapered with
indexation, rest
of characteristics
same as
Microdent
Ektos) | Connection type | Internal connection with
hex. | Internal connection
with tapered
indexation. | Internal connection
with hex. | Yes with Legacy
(Hex
connection)
Different
connection from
Genius implant |
| Intended | Microdent Ektos Implant | Microdent Genius Implant | The intended use of the | Yes (Microdent | Surface treatment | Blasting
(roughness 0,82
μm
peak-to-valley). | same | SBM (Soluble Blast
Media) or
HA-coated. (SBM
roughness 1.5-2.3
μm peak-to-valley). | Yes (Blasted
treatment with
similar result) |
| | | | | | Sterilization | Sterile (Gamma
irradiation) | same | same | Yes |
| use | 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. | 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. | Legacy System Implants with
HA Coating is identical to the
intended use of the predicate
abutments. These implants
are two-piece implants for
single-stage or two-stage
surgical procedures. The
Legacy implants are intended
for use in the mandible and
maxilla, in support of single or
multiple-unit cement or screw
receiving fixed restorations
and for retention and support
of overdentures. The implants
are intended for immediate
placement and function for
support of single tooth and/or
multiple tooth restorations,
recognizing bone stability and
appropriate occlusal load
requirements. | Ektos specified
the use of small
diameter implants,
Legacy System
are coated
blasted or HA
plasma) | Packaging | Inner sleeve to
suspend the
implant/fixture-m
ount assembly
packaged inside
an outer vial
sealed with a cap.
Packaging also
includes surgical
cover screw and
multi-function
abutment. | Packaged in sterile
vial with cover
screw | Inner sleeve to
suspend the
implant/fixture-mo
unt assembly
packaged inside
an outer vial sealed
with a cap.
Packaging also
includes surgical
cover screw,
extender and
temporary coping. | Yes (but Legacy
includes an
extender) |
| Indication | Delayed or
immediate load | same | same | Yes | Shelf Life | 5 years | same | same | Yes |
| Material | Comercially pure
titanium (grade
4 as ISO 5832-2) | same | Titanium Alloy
(grade 5 as ISO
5832-3) | Yes (Different
degree but with
very similar
properties) | Mating
Components | All Microdent
Restorative
Components | All Microdent
Restorative
Components | All Legacy
Restorative
Components | Yes |
| Design; | Threaded, root
form implant.
Image: Threaded, root form implant | same
Image: Threaded, root form implant | same
Image: Threaded, root form implant | Yes (Legacy
implant has
quadruple-lead
threads near top)
Image: Threaded, root form implant | | | | | |
| Length (mm) | 8, 10, 12, 14, 16
and 18 mm. | 8, 10, 12, 14, 16 and
18 mm. | 8, 10, 11.5, 13 and
16 mm | Yes | | | | | |
| Platform | Diameter ranges:
3.5 mm, 4.5 mm
and 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 5.7
mm | Yes | | | | | |
10
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.
11
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
12
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 Ektos | |||
| implant abutments | Microdent Genius | |||
| implant abutments | Legacy Abutment | |||
| System | 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 Ektos
cover screw | Microdent Genius
cover screw | Legacy cover screw | Yes |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510K | NA | K141188 | K073033 | 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 and 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 intended use of the
Legacy System Implants with
HA Coating is identical to the
intended use of the predicate
abutments. These implants
are two-piece implants for
single-stage or two-stage
surgical procedures. The
Legacy implants are intended
for use in the mandible and
maxilla, in support of single or
multiple-unit cement or screw
receiving fixed restorations
and for retention and support
of overdentures. The implants
are intended for immediate
placement and function for
support of single tooth and/or
multiple tooth restorations,
recognizing bone stability and
appropriate occlusal load
requirements. | Yes (Microdent
Ektos specified
the use of small
diameter
implants,
Legacy System
are coated
blasted or HA
plasma) |
| Design; | 3 diameters and
metric thread M1.8 | One diameter | same | Yes (Microdent
Genius has one
diameter and
smaller) |
| Collar Height
(mm, min
-max) | Without heights | same | same | Yes |
| Seating
Surface (mm) | Diameter 3.5 mm,
4.5 mm and 5.7
mm. | Diameter 2.9 mm. | same | Yes (Microdent
Genius has one
diameter and
smaller) |
| Connection
type | Internal connection
tapered. | | Internal connection
tapered. | Yes |
| Sterilization | Sterile (Gamma
irradiation) | same | same | Yes.
Packaged
sterile with the
implant |
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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 Ektos
Healing Abutment | Microdent Genius
Healing Abutment | Legacy
Collar
Healing | 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). | |
| Design; | 4 diameters and
metric thread M1.8 | One diameter | One diameter and
metric thread M1.8 | Yes | |
| Collar Height
(mm, min
-max) | 0 mm to 4 mm | 1 mm to 6 mm | 3 and 5 mm | Yes | |
| Seating
Surface (mm) | Diameter from 3.5,
4.5, 5.6 and 6.5
mm. | Diameter from
4.5, 5 and 5.5 mm. | Diameter from
3.7, 4.7, 5.7 and 6.5
mm. | Yes | |
| Connection | Internal connection | same | same | Yes | |
| Device Name | Microdent Ektos
Retention screw | Microdent Genius
Retention screw | Legacy
screw | Fixation | 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). | |
| Design; | This screw having
a threaded fuse and
a head with a
hexagon 1.20 mm
flat to flat. | same | same | Yes | |
| Seating
Surface (mm) | This is a single
Retention screw for
all platforms | same | same | Yes | |
| Device Name | Microdent Ektos
Conical abutment | Microdent Genius
Conical abutment | Legacy
straight abutments | 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) | |
| Design | 3 diameters and
hex connection
(Microdent Ektos).
Abutment with flap
and without flap. | 3 diameters and
same connection
(Microdent
Genius).
Abutment with
flap and without
flap. | 4 diameters and hex
connection
(Legacy).
Abutments
Contoured and
Full-contoured. | Yes, but
Microdent
Ektos and
Legacy have
the same hex
connection.
Microdent
Genius has
connection
tapered with | |
| | Microdent Ektos
inmediate loading
abutment with slots
on outer taper
surface. | Microdent Genius
inmediate loading
abutment with slots
on outer
taper surface. | Design for
inmediate loading
is called Titanium
Temporary
Abutments and
have not slots on
taper surface. | indexation, rest
of
characteristics
same to
Microdent
Ektos. | |
| | Multifunction
abutment. | Not available. | Fixture-Mount. | Yes, but
Fixture-Mount
has the same
function than
multifunction
abutment
using two
pieces. | |
| Collar Height
(mm, min
-max) | 1 mm to 5 mm | 1 mm to 6 mm | 1, 2 and 3 mm | Yes (Legacy
has not height
4 and 5 mm,
but Genius yes) | |
| Seating
Surface (mm) | Diameter from 4.5,
5.6 and 6.2 mm. | Diameter from
4.5, 5 and 5.5 mm. | Diameter from 3.7,
4.7, 5.7 and 6.5
mm. | Yes | |
| Connection
type | Internal hex
connection (H) or
circular (R). | Internal
connection
tapered with
indexation (H) or
only tapered (R). | Internal hex
connection
(Engaging) or
Non-Engaging. | Yes
Microdent
Ektos and
Legacy have
the same hex
connection.
Microdent
Genius has
connection
tapered with
indexation, rest
of
characteristics
same to
Microdent
Ektos | |
| Device Name | Microdent Ektos
Mini Capitel
abutment | Microdent Genius
Mini Capitel
abutment | Legacy
Screw-Receiving
Overdenture
Abutments | 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.) | |
| Design | One prosthetic
diameter of 4,8
mm. | One prosthetic
diameter of 4,8
mm. | One prosthetic
diameter 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) | | | | | |
| Seating
Surface (mm) | Diameter ranges:
3.5 mm, 4.5 mm
and 5.7 mm. | Diameter ranges:
3.5 mm, 4.5 mm,
5.0 and 5,5 mm. | Diameter ranges:
3.0, 3.5 mm, 4.5
mm and 5.7 mm. | Yes | |
| Connection
type | Internal connection
tapered (R). | Internal
connection
tapered (R). | Internal connection
tapered
(Non-engaging) | Yes (These
Ektos
abutments are
used only for
multiple screw
prosthesis) | |
| Copings | Cementable coping
of Titanium (Grade
5). | Cementable
coping of
Titanium (Grade
5) | Two cementable
coping of Gold and
titanium.
Plastic coping.
Gold&Plastic
Coping.
Titanium
Temporary Coping. | Yes (Legacy
has more
components) | |
| Device Name | Microdent Ektos
Osscilia retention
abutment | Microdent Genius
Osscilia retention
abutment | Legacy
Abutments | Ball | 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.) |
| Design; | Diameter ranges:
3.5 mm, 4.5 mm
and 5.7 mm.
Compensation 17°. | One prosthetic
diameter of 3.5
mm.
Compensation
17°. | Diameter ranges:
3.5 mm, 4.5 mm
and 5.7 mm.
Compensation 28°. | Yes | |
| Retention: | Three types of
retainers (with | Three types of
retainers (with | Housing and a type | Yes | |
| | dimensional
variations) varies
the cap retainer. | dimensional
variations) varies
the cap retainer. | of retainer. | (Microdent
Genius and
Ektos have 3
retainers with
different
friction and
Legacy only
one.) | |
| | 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 | |
| Seating
Surface (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 | |
| Connection
type | Internal connection
tapered. | Internal
connection
tapered. | Internal connection
tapered. | Yes | |
15
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.
16
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.
18
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.
19
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.
20
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
- . Bacterial endotoxin LAL test USP
- 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.