Straumann® Mini Implants ø2.4 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. Strauman® Mini Implants are intended for the stabilization of removable dentures.

Device Description

The Straumann Mini Implants are tapered implants with an external diameter of 2.4 mm and lengths of 10, 12, and 14 mm. Standard manufacturing processes such machining, surface treatment, cleaning, packaging and sterilization were applied for the subject devices. There are no significant changes related to the implant material, surface treatment, fundamental operating principles, sterilization processes or procedures between the subject devices and the reference devices cleared under K083550. The main difference is the Optiloc® attachment element incorporated on the top of the implant. The implants are manufactured utilizing the Roxolid material and are finished with SLA® surface. The implant neck is machined and the Optiloc® attachment element of the implants is acting as a retention feature for dentures and it is coated using a Titanium Nitride (TiN) coating. Straumann® Mini Implants Ø2.4 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. The Straumann Mini Implants are intended for the stabilization of removable dentures. The removable dentures are connected to the Mini Implants through the incorporated Optiloc® attachment element.

AI/ML Overview

This document describes a 510(k) premarket notification for the Straumann® Mini Implants. The information provided heavily focuses on the comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical study evaluating the device's performance against specific quantitative acceptance criteria in a human population.

Therefore, many of the requested details regarding acceptance criteria for device performance in a clinical setting, sample sizes for test sets, expert involvement for ground truth, and MRMC studies will not be present in this type of regulatory submission. The performance testing outlined here is primarily bench testing to demonstrate mechanical and material equivalence.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The document does not specify quantitative clinical performance acceptance criteria (e.g., success rates, complication rates) and corresponding reported device performance from a clinical trial. Instead, the "acceptance criteria" discussed are related to bench testing for demonstrating equivalence to predicate devices.

Table 1: Acceptance Criteria (Bench Testing) and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Implicit from Equivalence Claim)	Reported Device Performance (Summary from Bench Testing)
Insertion Torque	Reach a suitable implant insertion torque, comparable to predicate/reference devices.	Average value of insertion torque measurements for each bone plate density and each implant length are "within the defined acceptance criteria."
Wear Testing (Optiloc® attachment retention)	Retention force loss of the Optiloc® blue ring within acceptable limits.	The retention force loss of the Optiloc® blue ring on Straumann Mini Implants "passed the acceptance criteria."
Biocompatibility	No new issues raised compared to previously cleared materials.	Roxolid material and TiN coating previously cleared (K083550, K190040).
Sterilization	Achieve a Sterility Assurance Level (SAL) of 10^-6.	Validated in accordance with ISO 11137-1:2006 and ISO 11137-2:2013, achieving SAL of 10^-6.
Shelf Life	Maintain integrity and sterility for 5 years.	Determined through real-time and accelerated aging (ASTM F 1980) to be 5 years.
Pyrogenicity	Meet pyrogen limit specifications.	Testing limit of 20 EU/device met via LAL Endotoxin Analysis.
Dynamic Fatigue	Mechanical performance comparable to predicate devices under dynamic loading.	Demonstrated equivalence to primary predicate devices in tests conducted according to ISO 14801 and FDA Guidance.

Study Details (Based on Provided Document)

Given that this is a 510(k) submission primarily relying on substantial equivalence through bench testing, a traditional clinical study with a "test set" in the context of AI/diagnostic device evaluation (as implied by the detailed questions) was not conducted or reported here. The performance testing discussed pertains to physical and mechanical characteristics of the dental implants.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set for AI/diagnostic performance. The "test set" here refers to the samples of the physical device used for bench testing (e.g., number of implants for insertion torque, wear, and fatigue tests). Specific quantities are not provided, but these are typically small, controlled laboratory samples.
- Data Provenance: Not applicable in terms of patient data. The data provenance is from laboratory bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a physical device's mechanical properties is established through standardized engineering tests, not expert consensus on medical images or clinical outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies to human reader studies or data labeling, not bench testing of a physical implant.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is irrelevant to the evaluation of a dental implant's mechanical and material properties. The device is a physical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This also refers to AI/software performance, not a dental implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on engineering standards and specifications (e.g., ISO 14801, ISO 11137), and the properties of the previously cleared predicate devices. For example, a successful fatigue test to a certain threshold is "ground truth" for mechanical durability.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As noted above, there is no training set for this type of device.

Summary of what the document primarily reports:

The document, a 510(k) summary, demonstrates the substantial equivalence of the Straumann® Mini Implants to legally marketed predicate devices. This is achieved by:

Comparing Indications for Use: Showing the new device's indications are equivalent to a predicate (K031106), with one difference (not indicated for inter-radicular transitional applications) that does not raise new safety or effectiveness questions.
Comparing Technological Characteristics: Detailing similarities and differences in material, dimensions, coating, surface treatment, etc., with predicates and reference devices (Table 1).
Performance Testing (Bench Testing): Conducting various engineering tests (insertion torque, wear, biocompatibility, sterilization, shelf life, pyrogenicity, dynamic fatigue) and demonstrating that the device meets internal "acceptance criteria" for these tests, which are implicitly set to show equivalence to or non-inferiority against the predicate devices' known performance. The tests adhere to relevant FDA guidance and ISO standards.

This type of submission is common for Class II medical devices where clinical trials are not explicitly required if substantial equivalence can be demonstrated through non-clinical means.

Summary

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December 9, 2019

Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K191895

Trade/Device Name: Straumann® Mini Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: September 9, 2019 Received: September 10, 2019

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 (OS) 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.

for 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 Ouality 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)

K191895

Device Name :

Straumann® Mini Implants

Indications for Use (Describe)

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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Straumann® Mini Implants

510(k) Summary

5 510(k) Summary

5.1 Submitter's Contact Information

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)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:	Viviana HorhoiuRegulatory Affairs and Compliance ManagerInstitut Straumann AGPhone number : +41 61 965 1512
Date of Submission:	December 9, 2019

5.2 Name of the Device

Trade Names:	Straumann Mini Implants
Common Name:	Endosseous Dental Implant
Classification Name:	Endosseous Dental Implant
Regulation Number:	§872.3640
Device Classification :	II
Product Code(s):	DZE
Proprietary Name:	Straumann Mini Implants

5.3 Predicate Device(s)

Primary Predicate:

K031106 IMTEC Sendax MDI and MDI Plus •

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Straumann® Mini Implants

510(k) Summary

Reference Devices:

K083550 Straumann Dental Implant System ●
K190040 Straumann BLX Line Extension New Abutments .
K190662 MRI Compatibility for Existing Straumann Dental Implant Systems ●

5.4 Device Description

The Straumann Mini Implants are tapered implants with an external diameter of 2.4 mm and lengths of 10, 12, and 14 mm.

Standard manufacturing processes such machining, surface treatment, cleaning, packaging and sterilization were applied for the subject devices. There are no significant changes related to the implant material, surface treatment, fundamental operating principles, sterilization processes or procedures between the subject devices and the reference devices cleared under K083550. The main difference is the Optiloc® attachment element incorporated on the top of the implant.

The implants are manufactured utilizing the Roxolid material and are finished with SLA® surface. The implant neck is machined and the Optiloc® attachment element of the implants is acting as a retention feature for dentures and it is coated using a Titanium Nitride (TiN) coating.

Straumann® Mini Implants Ø2.4 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. The Straumann Mini Implants are intended for the stabilization of removable dentures. The removable dentures are connected to the Mini Implants through the incorporated Optiloc® attachment element.

5.5 Indications for Use

Straumann® Mini Implants Ø2.4 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. Straumann® Mini Implants are intended for the stabilization of removable dentures.

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Straumann® Mini Implants

510(k) Summary

Technological Characteristics 5.6

The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1. The Indications for Use for the subject devices differs from the primary predicate (K031106) with respect to the indication for inter-radicular transitional applications. The subject devices are not indicated for interradicular transitional applications, however, the remaining indications are equivalent. The reference predicate K190662 is included for reference to all MRI compatibility. The reference predicate K190040 is included for reference to the TiN coating on the Straumann BLX Novaloc Abutments (for clarity only this portion of the cleared Indications for Use Statement for K190040 is included in Table 1).

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Straumann® Mini Implants

510(k) Summary

FEATURE	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE
K Number	K191895	K031106	K083550	K190040
Indications forUse	Straumann® Mini Implants Ø2.4 mmare suitable for oral endostealimplantation in the upper and lowerjaw of fully or partially edentulouspatients. The implants can be placedwith immediate function when goodprimary stability is achieved.Straumann® Mini Implants areintended for the stabilization ofremovable dentures.	The MDI and MDI PLUS are self-tapping titanium threaded screwsindicated for long-term intra-bonyapplications.Additionally, the MDI may also beused for inter-radicular transitionalapplications.These devices will permit immediatesplinting stability and long-termfixation of new or existing crown andbridge installations, for full partialedentulism, and employing minimallyinvasive surgical intervention.	Straumann® dental implants aresuitable for the treatment of oralendosteal implantation in the upperand lower jaw and for the functionaland esthetic oral rehabilitation ofedentulous and partially dentatepatients (unless specific indicationsand limitations are present, as statedbelow). Straumann® dental implantscan also be used for immediate orearly implantation following extractionor loss of natural teeth. Implants canbe placed with immediate function onsingle-tooth and/or multiple toothapplications when good primarystability is achieved and withappropriate occlusal loading, torestore chewing function. Theprosthetic restorations used aresingle crowns, bridges and partial orfull dentures, which are connected tothe implants by the correspondingelements (abutments). When placingimplants in the posterior region, werecommend using only largediameter implants. In cases of fullyedentulous patients, 4 or moreimplants must be used in immediatelyloaded cases.Specific indications for smalldiameter (Ø3.3 mm) implants:Because of their reduced mechanicalstability, small diameter implants areonly used in cases with a lowmechanical load. Placement in themolar region is not recommended.	Straumann BLX Novaloc AbutmentsThe Straumann® Retentive System isindicated for the attachment of full orpartial dentures on Straumann dentalimplants.
ImplantDiameter	2.4 mm	2.4 mm	3.3 mm	The reference device is not animplant

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Straumann® Mini Implants

510(k) Summary

FEATURE	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE
K Number	K191895	K031106	K083550	K190040
Implant Length	10, 12, 14 mm	10, 13, 15, 18 mm	8, 10, 12, 14, 16 mm	The reference device is not animplant
Material	Roxolid	Ti-6Al-4V	Roxolid	Ti-6Al-4V
Coating	TiN coated	No coating	No coating	TiN coated
SurfaceTreatment	SLA	Not available	SLA	Partially anodized
Abutment-to-restorationconnection	Anchor ball	O-Ball	Screw retained	Snap-on feature
Type ofrecommendedrestoration	Stabilization of removable dentures	Stabilization of removable dentures	Support for prosthetic devices,crowns, bridges and overdentures	Attachment of full or partial dentureson dental implants
SterilizationMethod	Gamma irradiation	No information available	Gamma irradiation	Not provided sterile

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

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Straumann® Mini Implants

510(k) Summary

5.7 Performance Testing

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 Straumann Mini Implants are equivalent to the predicate and reference devices.

The purpose of the insertion torque test is to check that the Straumann Mini Implants and the related cutting instruments make it possible to reach a suitable implant insertion torque. The average value of insertion torque measurements for each bone plate density and each implant length are within the define acceptance criteria. Wear testing is performed to evaluate the performance of the Optiloc® attachment with regard to its retention properties. The retention force loss of the Optiloc® blue ring on Straumann Mini Implants passed the acceptance criteria.

No new issues of biocompatibility are raised for the subject devices. The Roxolid material was previously cleared per K083550 and the TiN coating was previously cleared per K190040.

The sterilization process for the Straumann Mini Implants as recommended in the labeling 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 sterilized via gamma irradiation at a dose of 25 kilogray (2.5 Mrad) Minimum and will be sterilized 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 real time and accelerated (according to ASTM F 1980 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices) samples. The subject devices will not be marketed as non-pyrogenic. The method used to make the determination that the device meets pyrogen limit specifications is LAL Endotoxin Analysis. The testing limit is 20 EU/device.

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Straumann® Mini Implants

510(k) Summary

Dynamic fatigue testing was conducted according to ISO 14801, Dentistry – Implants – Dynamic fatigue test for endosseous dental implants and to the FDA Guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". The tests were conducted in ambient air at room temperature and demonstrated the Straumann Mini Implants are equivalent to the primary predicate devices.

5.8 Conclusion

The documentation submitted in this premarket notification demonstrates the Straumann Mini 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.