MINICONE Implants ø2.6 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 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.

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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the MINICONE Implant, a dental device. It does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance. The information provided is for a traditional medical device, specifically an endosseous dental implant, and focuses on performance testing for mechanical properties and sterilization.

Therefore, many of the requested categories for AI/algorithm-related studies cannot be answered from the provided text.

Here's a breakdown of the information that can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Insertion Torque Testing	Equivalent to predicate and reference devices	Demonstrated equivalence
Wear Testing (Optiloc® attachment element retention properties)	Retention force loss of all Optiloc® 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 to predicate and reference devices.	Passed acceptance criteria and demonstrated substantial equivalence.
Fatigue Testing (ISO 14801)	Dynamic fatigue strength demonstrated substantial equivalence to predicate and reference devices.	Demonstrated substantial equivalence.
Biocompatibility	No new issues raised.	Titanium Grade 5 ELI and TiN coating previously cleared (per K081653).
Sterilization (Beta irradiation)	Achieve a Sterility Assurance Level (SAL) of 10-6.	Validated according to ISO 11137-1:2006 and ISO 11137-2:2013 with a SAL of 10-6 at a dose of 25 kGy (2.5 Mrad) minimum.
Shelf Life	Not explicitly stated, but implies meeting a target shelf life.	Five years, determined through accelerated aging tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes the types of engineering and mechanical tests performed (insertion torque, wear, fatigue), but does not specify sample sizes for these tests, nor the "data provenance" in the context of clinical/imaging data as typically asked for AI studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes performance testing for a physical medical device (dental implant), not an AI algorithm that requires expert ground truth for interpretation of images or other data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm requiring adjudication of interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm that would be used in conjunction with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable in the context of AI studies. For the engineering tests performed:

Insertion Torque, Wear, Fatigue: Ground truth is established by measured physical properties against established industry standards (e.g., ISO 14801) and comparison to predicate devices, rather than expert consensus on interpretations of data.
Biocompatibility: Ground truth is based on the known, previously cleared status of the materials (Titanium Grade 5 ELI and TiN coating).
Sterilization: Ground truth is established by validated processes against microbiological standards (SAL of 10-6 according to ISO 11137-1 and -2).
Shelf Life: Ground truth is established by accelerated aging tests projecting real-time performance.

8. The sample size for the training set

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm that requires a training set with ground truth.

Summary

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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

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200906

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)

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MINICONE

510(k) Summary 5

5.1 Submitter's Contact Information

Submitter:	Straumann USA, LLC (on behalf of MEDENTIKA GmbH)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023E-mail: jennifer.jackson@straumann.com
Prepared By &Alternate Contact:	Dr. Gerhard PolzerHead of Regulatory AffairsMEDENTIKA GmbHPhone 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

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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.

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.

5.5 Intended Use

MINICONE Implants are intended for the stabilization of removable dentures.

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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.

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MINICONE

510(k) Summary

FEATURE	SUBJECT DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE DEVICE	REFERENCE DEVICE
K Number	K200906	K191895	K081653	K050705
Indications for Use	MINICONE Implants are intendedfor the stabilization of removabledentures.MINICONE Implants are suitablefor oral endosteal implantation inthe upper and lower jaw of fully orpartially edentulous patients.The implants can be placed withimmediate function when goodprimary stability is achieved.Furthermore, they are to be usedin combination with thecorresponding prosthetic Optiloc®matrix system and individual newor existing Optiloc® compatibleoverdentures or partial dentures.For mandibular restorations, atleast 4 MINICONE Implantsshould be placed. For maxillaryrestorations, at least 6 MINICONEImplants should be placed.	STRAUMANN MINI IMPLANTS areintended for the stabilization ofremovable dentures.STRAUMANN MINI IMPLANTS aresuitable for oral endostealimplantation in the upper and lowerjaw of fully or partially edentulouspatients.The implants can be placed withimmediate function when goodprimary stability is achieved.Furthermore, they are to be used incombination with the correspondingprosthetic Optiloc® matrix systemand individual new or existingOptiloc® compatible overdentures orpartial dentures.For mandibular restorations, at least4 STRAUMANN MINI IMPLANTSshould be placed. For maxillaryrestorations, at least 6STRAUMANN MINI IMPLANTSshould be placed.	The MII Implant is intended tosupport single unit or multi-unitrestorations in both long-term andtemporary applications throughoutthe maxillary and mandibulararches.TheMII implant is indicated forimmediate loading when goodprimary stability is achieved.Additionally, this device will permitstability and long-term fixation ofupper and lower dentures inedentulous cases	Nobel Biocare TiUnite® Implants areroot-form endosseous implantsintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such as anartificial tooth, in order to restorepatient esthetics and chewingfunction. Nobel Biocare TiUnite®Implants are indicated for single ormultiple unit restorations in splintedor non-splinted applications. NobelBiocare TiUnite® Implants may beplaced immediately and put intoimmediate function providing thatthe initial stability requirementsdetailed in the surgical manuals aresatisfied.TiUnite® implants are indicated foruse in soft bone wheneverimmediate or early loading isapplied. The TiUnite® implants arepreferred in these soft boneindications because bone formationis more rapid and greater than onmachined surface implants resultingin better maintenance of initialimplant stability, faster and strongerosseointegration, and highersuccess 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 ElementCoating	TiN coated at the retentionelement	TiN coated at the retention element	TiN coated at the retention element	N/A
FEATURE	SUBJECT DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE DEVICE	REFERENCE DEVICE
K Number	K200906	K191895	K081653	K050705
Endosseous SurfaceTreatment	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-restorationconnection	Optiloc® geometry(Optimized Ball attachmentelement)	Optiloc geometry(Optimized ball attachment element)	O-Ball and tapered abutment design	Internal Tri-channel
Type ofrecommendedrestoration	Stabilization of removabledentures	Stabilization of removable dentures	Support of single-unit or multi-unitrestorations for fixed and removableapplications	Support of single-unit or multi-unitrestorations for fixed and removableapplications
Sterilization Method	Beta irradiation	Gamma irradiation	Gamma irradiation	Irradiation

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MINICONE

510(k) Summary

Table 1 – Comparison of subject device versus predicate/reference devices

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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.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.