(193 days)
No
The summary describes a physical dental implant and its accessories, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a dental implant intended for the stabilization of removable dentures, which is a structural and supportive function, not a direct therapeutic treatment of a disease or condition.
No
Explanation: The device is described as a dental implant system used for the stabilization of removable dentures, and its function involves physical implantation and retention, not diagnosing conditions or diseases.
No
The device description clearly states that the device consists of physical dental implants made of Titanium Grade 5 ELI material, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The MINICONE device is a dental implant intended for the stabilization of removable dentures by being surgically implanted into the jawbone. It is a physical device used in vivo (within the body) for mechanical support.
- Intended Use: The intended use clearly states its purpose is for stabilizing dentures, not for analyzing biological samples.
- Device Description: The description focuses on the materials, dimensions, and mechanical features of the implant and its attachment system.
- Performance Studies: The performance studies described (insertion torque, wear testing, fatigue testing) evaluate the mechanical and structural integrity of the implant, not its ability to analyze biological samples.
Therefore, the MINICONE device falls under the category of a medical device used for structural support and stabilization within the body, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MINICONE are dental implants that are intended for the stabilization of removable dentures.
MINICONE Implants ø2.6 mm are suitable for oral endosteal implantation in the upper and lower iaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Furthermore, they are to be used in combination with the corresponding prosthetic Optiloc® matrix system and individual new or existing Optiloc® compatible overdentures or partial dentures.
For mandibular restorations, at least 4 MINICONE Implants should be placed.
For maxillary restorations, at least 6 MINICONE Implants should be placed.
Product codes
DZE
Device Description
MINICONE consists of 2 MINICONE tapered implants with an external diameter of 2.6 mm and lengths of 10 and 12 mm, as well as related accessories.
The implants are manufactured utilizing Titanium Grade 5 ELI material (Ti-4Al-6V) and are finished with a roughened surface (sandblasted/acid etched). The implant neck is machined, and the attachment element of the implants is acting as a retention feature for dentures. This retention feature is coated using a Titanium Nitride (TiN) to obtain a more wear resistant surface and has the Optiloc® geometry which is connected to the denture. The roughened surface, implant neck, and retention feature are shown in Figure 1.
MINICONE Implants Ø2.6mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients.
The implants can be placed with immediate function when good primary stability is achieved. The MINICONE implants are intended for the stabilization of removable dentures. The removable dentures are connected to the MINICONE implants through the incorporated Optiloc® attachment element.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw
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)
Insertion torque testing and wear testing were conducted according to the FDA quidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the MINICONE implants are equivalent to the predicate and reference devices.
Wear testing is performed to evaluate the performance of the Optiloc® attachment element regarding its retention properties. The retention force loss of all Optilo® matrices (white, yellow, green, blue, red, black ring) on MINICONE implants with 0°, 10° and 20° angulation passed the acceptance criteria and demonstrated substantial equivalence.
Fatigue testing of the MINICONE implants was conducted according to ISO 14801. The dynamic fatigue strength of the MINICONE implants demonstrated substantial equivalence. No new issues of biocompatibility are raised for the subject devices. The titanium grade 5 ELI material and the TiN coating were previously cleared per K081653.
The sterilization process for the MINICONE implants was validated in accordance with ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05. The subject devices are cleaned, disinfected and sterilized via beta irradiation at a dose of 25 kGy (2.5 Mrad) minimum after packaging. A sterility assurance level (SAL) of 10-6 had been validated according to the standard cited above. The validation method used was the over kill bioburden method in accordance with ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.
The subject devices are single use and are provided sterile. The shelf life is five years. Shelf life determination has been conducted in accelerated aging tests.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 16, 2020
MEDENTiKA GmbH % Jennifer Jackson Director, Regulatory Affairs Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K200906
Trade/Device Name: MINICONE Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: September 15, 2020 Received: September 16, 2020
Dear Jennifer Jackson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name:
MINICONE Implant
Indications for Use (Describe)
MINICONE are dental implants that are intended for the stabilization of removable dentures.
MINICONE Implants 02.6 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Furthermore, they are to be used in combination with the corresponding prosthetic Optilo® matrix system and individual new or existing Optiloc® compatible overdentures or partial dentures.
For mandibular restorations, at least 4 MINICONE Implants should be placed.
For maxillary restorations, at least 6 MINICONE Implants should be placed.
Type of Use (Select one or both, as applicable) 図Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED
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3
MINICONE
510(k) Summary 5
5.1 Submitter's Contact Information
| Submitter: | Straumann USA, LLC (on behalf of MEDENTIKA GmbH)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs and Quality
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023
E-mail: jennifer.jackson@straumann.com |
| Prepared By &
Alternate Contact: | Dr. Gerhard Polzer
Head of Regulatory Affairs
MEDENTIKA GmbH
Phone number: +49 7229 6991216 |
| Date of Submission: | October 14, 2020 |
5.2 Name of the Device
| Trade Names: | MINICONE |
|---|---|
| Common Name: | Endosseous Dental Implant |
| Classification Name: | Endosseous Dental Implant |
| Regulation Number: | 21 CFR 872.3640 |
| Device Classification: | II |
| Product Code(s): | DZE |
| Review Branch: | Dental |
Predicate Device(s) 5.3
Primary Predicate:
- . K191895 — Straumann Mini implants
4
MINICONE
510(k) Summary
Reference Devices:
- K081653 MDI MII One-piece Implant 2.9 mm .
- K050705 TiUnite Implants (Nobel Biocare) .
- K180564 Medentika Abutment System .
5.4 Device Description
MINICONE consists of 2 MINICONE tapered implants with an external diameter of 2.6 mm and lengths of 10 and 12 mm, as well as related accessories.
The implants are manufactured utilizing Titanium Grade 5 ELI material (Ti-4Al-6V) and are finished with a roughened surface (sandblasted/acid etched). The implant neck is machined, and the attachment element of the implants is acting as a retention feature for dentures. This retention feature is coated using a Titanium Nitride (TiN) to obtain a more wear resistant surface and has the Optiloc® geometry which is connected to the denture. The roughened surface, implant neck, and retention feature are shown in Figure 1.
Image /page/4/Figure/10 description: The image shows a dental implant with labels pointing to different parts of the implant. The top of the implant is labeled as the "Retention Feature". The middle of the implant is labeled as the "Implant Neck", and the bottom of the implant is labeled as the "Roughened Surface".
Figure 1 - MINICONE Implant
MINICONE Implants Ø2.6mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients.
The implants can be placed with immediate function when good primary stability is achieved. The MINICONE implants are intended for the stabilization of removable dentures. The removable dentures are connected to the MINICONE implants through the incorporated Optiloc® attachment element.
5.5 Intended Use
MINICONE Implants are intended for the stabilization of removable dentures.
5
MINICONE
510(k) Summary
Indications for Use 5.6
MINICONE are dental implants that are intended for the stabilization of removable dentures. MINICONE Implants ø2.6 mm are suitable for oral endosteal implantation in the upper and lower iaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Furthermore, they are to be used in combination with the corresponding prosthetic Optiloc® matrix system and individual new or existing Optiloc® compatible overdentures or partial dentures.
For mandibular restorations, at least 4 MINICONE Implants should be placed.
For maxillary restorations, at least 6 MINICONE Implants should be placed.
5.7 Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate (K191895) and reference devices in Table 1. There are no significant changes related to the implant surface treatment, fundamental operating principles, sterilization processes or procedures between the subject devices and the predicate devices cleared under K191895. The subject implant diameter is 0.2 mm larger than the primary predicate device and the thread design of the subject implant incorporates a coronal micro-thread. Both devices are made of Titanium alloys, whereas MINICONE implants are manufactured from Titanium-6Aluminum-4Vanadium (Titanium Grade 5 ELI according to ASTM F136) and the reference devices from Titanium-Zirconium (Roxolid®). Furthermore, there is no difference regarding the Optiloc® attachment element incorporated on the top of the implants.
The reference predicate K180564 is included for reference to MRI compatibility. The reference device K081653 is included for reference to the implant material Titanium grade 5 ELI (Ti-6Al-4V). The reference device K050705 is included for reference to the machined collar of the implant which can be placed up to 1.5 mm subcrestally. The machined collar of the subject device can also be placed up to 1.5 mm subcrestally. The remaining 1.5 mm of the machined collar is intended for gingival support.
The Indications for Use of the subject device are similar to the Indications for Use of the primary predicate and reference devices, K191895 and K081653. The Indications for Use for K050705 includes single tooth restorations which is not applicable for the subject device. The Indications for Use are substantially equivalent.
6
MINICONE
510(k) Summary
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K200906 | K191895 | K081653 | K050705 |
| Indications for Use | MINICONE Implants are intended
for the stabilization of removable
dentures.
MINICONE Implants are suitable
for oral endosteal implantation in
the upper and lower jaw of fully or
partially edentulous patients.
The implants can be placed with
immediate function when good
primary stability is achieved.
Furthermore, they are to be used
in combination with the
corresponding prosthetic Optiloc®
matrix system and individual new
or existing Optiloc® compatible
overdentures or partial dentures.
For mandibular restorations, at
least 4 MINICONE Implants
should be placed. For maxillary
restorations, at least 6 MINICONE
Implants should be placed. | STRAUMANN MINI IMPLANTS are
intended for the stabilization of
removable dentures.
STRAUMANN MINI IMPLANTS are
suitable for oral endosteal
implantation in the upper and lower
jaw of fully or partially edentulous
patients.
The implants can be placed with
immediate function when good
primary stability is achieved.
Furthermore, they are to be used in
combination with the corresponding
prosthetic Optiloc® matrix system
and individual new or existing
Optiloc® compatible overdentures or
partial dentures.
For mandibular restorations, at least
4 STRAUMANN MINI IMPLANTS
should be placed. For maxillary
restorations, at least 6
STRAUMANN MINI IMPLANTS
should be placed. | The MII Implant is intended to
support single unit or multi-unit
restorations in both long-term and
temporary applications throughout
the maxillary and mandibular
arches.
TheMII implant is indicated for
immediate loading when good
primary stability is achieved.
Additionally, this device will permit
stability and long-term fixation of
upper and lower dentures in
edentulous cases | Nobel Biocare TiUnite® Implants are
root-form endosseous implants
intended to be surgically placed in
the bone of the upper or lower jaw
arches to provide support for
prosthetic devices, such as an
artificial tooth, in order to restore
patient esthetics and chewing
function. Nobel Biocare TiUnite®
Implants are indicated for single or
multiple unit restorations in splinted
or non-splinted applications. Nobel
Biocare TiUnite® Implants may be
placed immediately and put into
immediate function providing that
the initial stability requirements
detailed in the surgical manuals are
satisfied.
TiUnite® implants are indicated for
use in soft bone whenever
immediate or early loading is
applied. The TiUnite® implants are
preferred in these soft bone
indications because bone formation
is more rapid and greater than on
machined surface implants resulting
in better maintenance of initial
implant stability, faster and stronger
osseointegration, and higher
success rates. |
| Implant Diameter | 2.6 mm | 2.4 mm | 1.8 mm | 3.5, 4.3, 5.0 and 6.0 mm |
| Design | One-piece implant | One-piece implant | One-piece implant | Two-piece implant |
| Implant Length | 10 and 12 mm | 10, 12, and 14 mm | 10, 13, 15, and 18 mm | 8, 10, 11.5, 13, and 16 mm |
| Material | Ti-6Al-4V (Titanium grade 5 ELI) | Ti- 15Zr (Roxolid) | Ti-6Al-4V | CP Titanium Grade 4 |
| Retention Element
Coating | TiN coated at the retention
element | TiN coated at the retention element | TiN coated at the retention element | N/A |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
| K Number | K200906 | K191895 | K081653 | K050705 |
| Endosseous Surface
Treatment | Blasting and acid etching | SLA | Blasting and acid etching | TiUnite |
| Machined Collar | 3 mm | N/A | N/A | 0.75 and 1.5 mm |
| Abutment-to-
restoration
connection | Optiloc® geometry
(Optimized Ball attachment
element) | Optiloc geometry
(Optimized ball attachment element) | O-Ball and tapered abutment design | Internal Tri-channel |
| Type of
recommended
restoration | Stabilization of removable
dentures | Stabilization of removable dentures | Support of single-unit or multi-unit
restorations for fixed and removable
applications | Support of single-unit or multi-unit
restorations for fixed and removable
applications |
| Sterilization Method | Beta irradiation | Gamma irradiation | Gamma irradiation | Irradiation |
7
MINICONE
510(k) Summary
Table 1 – Comparison of subject device versus predicate/reference devices
8
MINICONE
510(k) Summary
Performance Testing 5.8
Insertion torque testing and wear testing were conducted according to the FDA quidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the MINICONE implants are equivalent to the predicate and reference devices.
Wear testing is performed to evaluate the performance of the Optiloc® attachment element regarding its retention properties. The retention force loss of all Optilo® matrices (white, yellow, green, blue, red, black ring) on MINICONE implants with 0°, 10° and 20° angulation passed the acceptance criteria and demonstrated substantial equivalence.
Fatigue testing of the MINICONE implants was conducted according to ISO 14801. The dynamic fatigue strength of the MINICONE implants demonstrated substantial equivalence. No new issues of biocompatibility are raised for the subject devices. The titanium grade 5 ELI material and the TiN coating were previously cleared per K081653.
The sterilization process for the MINICONE implants was validated in accordance with ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05. The subject devices are cleaned, disinfected and sterilized via beta irradiation at a dose of 25 kGy (2.5 Mrad) minimum after packaging. A sterility assurance level (SAL) of 10-6 had been validated according to the standard cited above. The validation method used was the over kill bioburden method in accordance with ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.
The subject devices are single use and are provided sterile. The shelf life is five years. Shelf life determination has been conducted in accelerated aging tests.
Conclusion
The documentation submitted in this premarket notification demonstrates the MINICONE implants are substantially equivalent to the primary predicate and reference devices.