BoneTrust Mini Implant System

K200573 · Medical Instinct Deutschland GmbH · DZE · May 14, 2021 · Dental

Device Facts

• Record ID: K200573
• Device Name: BoneTrust Mini Implant System
• Applicant: Medical Instinct Deutschland GmbH
• Product Code: DZE · Dental
• Decision Date: May 14, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BoneTrust® Mini and Mini+ Implants are intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implant(s). Use of BoneTrust® Mini and Mini+ Implants is not to exceed one hundred and eighty (180) days. BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments are intended for use with BoneTrust® Mini / Mini+ Dental Implants to provisional prosthetic reconstructions during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments is not to exceed one hundred and eighty (180) days. BoneTrust® Mini Ball Attachments are intended to be used with BoneTrust® Mini / Mini+ Dental Implants to support and/or retain provisional removable dental prostheses during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Ball Attachments is not to exceed one hundred and eighty (180) days.

Device Story

BoneTrust® Mini Implant System comprises two-piece, root-form dental implants and associated abutments (Esthetic, Crown Base, Ball Attachments) for temporary prosthetic support. Implants are self-tapping, manufactured from Grade 4 titanium (machined or sand-blasted/acid-etched). Abutments are titanium alloy (Ti-6Al-4V). System uses external torx connection for implant-abutment interface. Intended for use in partially or fully edentulous mandibles and maxilla during healing phase of permanent implants; maximum duration 180 days. Implants supplied sterile (beta-radiation); abutments supplied non-sterile for end-user sterilization. Clinicians place implants surgically; prosthetic components are attached to support provisional restorations. System aids in restoring chewing function during healing period. Benefits include temporary stabilization of provisional prostheses, facilitating patient comfort and function while permanent implants integrate.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility assessment, bacterial endotoxin testing (USP <85>), sterilization validation (ISO 11137), shelf-life validation, and surface analysis (SEM/EDX).

Technological Characteristics

Implants: Grade 4 titanium (ISO 5832-2/ASTM F67). Abutments: Ti-6Al-4V alloy (ISO 5832-3/ASTM F136). Connection: External torx. Surface: Machined or sand-blasted/acid-etched/passivated. Sterilization: Beta-radiation (implants); end-user (abutments). Dimensions: Diameters 2.3-2.5mm, lengths 10.0-13.0mm.

Indications for Use

Indicated for partially or fully edentulous patients requiring temporary support for provisional prosthetic devices (fixed or removable) during the healing phase of permanent endosseous dental implants. Use limited to 180 days.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• EM Provisional; Hiossen, Inc. (K191751)

Reference Devices

• Sterngold 2.2mm Angled Micro ERA Dental Implant System (K092434)
• BoneTrust® Implant Systems, Medical Instinct Deutschland GmbH (K182313)
• MIS LOCKIT Abutments System, OT-Equators and Ball Attachments, MIS Implants Technologies Ltd. (K182228)
• Temporary Snap Abutment, Nobel Biocare AB (K161435)
• MS SA Implant System, OSSTEM Implant Co. Ltd. (K122171)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medical Instinct Deutschland GmbH % André Weingerl RA Consultant WRC Consulting Am Hohstetter 1a Steißlingen, Baden Württemberg 78256 GERMANY

Re: K200573

Trade/Device Name: BoneTrust® Mini Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 8, 2021 Received: April 12, 2021

Dear André Weingerl:

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 (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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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## Indications for Use

510(k) Number (if known) K200573

Device Name BoneTrust® Mini Implant System

### Indications for Use (Describe)

The BoneTrust® Mini and Mini+ Implants are intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implant(s). Use of BoneTrust® Mini and Mini+ Implants is not to exceed one hundred and eighty (180) days.

BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments are intended for use with BoneTrust® Mini / Mini+ Dental Implants to provisional prosthetic reconstructions during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments is not to exceed one hundred and eighty (180) days.

BoneTrust® Mini Ball Attachments are intended to be used with BoneTrust® Mini / Mini+ Dental Implants to support and/or retain provisional removable dental prostheses during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Ball Attachments is not to exceed one hundred and eighty (180) days.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <span> <span style="font-size:1.5em;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div style="display:flex; align-items:center;"> <span> <span style="font-size:1.5em;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## K200573

## VOLUME 006

## 510(k) Summary

Date of Submission 2021-14-05

APPLICANT: Medical Instinct Deutschland GmbH Graseweg 24 37120 Bovenden Germany Tel.: [phone] Fax.: [phone]

> E-Mail: [e-mail] Internet: www.medical-instinct.de

CONTACT PERSON: Jan Worlitz Managing Director Tel.: [phone] E-Mail: [e-mail]

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#### 1. Device Name

| Trade Name: | BoneTrust® Mini Implant System |
|----------------------|----------------------------------------------------------------|
| Classification Name: | Endosseous dental implant - Endosseous dental implant abutment |

#### 2. Classification Product Code / Subsequent Code

BoneTrust® Mini Implant system can be classified according to following Device Name and Product Code:

| Product Code: | DZE |
|-------------------------|-----------------|
| Device Class: | 2 |
| Classification Panel: | Dental |
| Regulation number: | 21 CFR 872.3640 |
| Secondary Product Code: | NHA |

## 3. Predicate device(s)

#### Primary Predicate Device .

| EM Provisional; Hiossen, Inc. | | #K191751 |
|-------------------------------------------------------------------|--|----------|
| • Reference Devices | | |
| Sterngold 2.2mm Angled Micro ERA Dental Implant System, Sterngold | | #K092434 |
| BoneTrust® Implant Systems, Medical Instinct Deutschland GmbH | | #K182313 |
| MIS LOCKIT Abutments System, OT-Equators and Ball Attachments, | | #K182228 |
| MIS Implants Technologies Ltd. | | |
| Temporary Snap Abutment, Nobel Biocare AB | | #K161435 |
| MS SA Implant System, OSSTEM Implant Co. Ltd. | | #K122171 |

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#### Device Description 4.

The BoneTrust® Mini Implant System is a two-piece dental implant system including various sizes of threaded root-form dental implants and abutments to provide temporary support of prosthetic restorations in edentulous or partially edentulous patients during the healing phase of permanent endosseous dental implant(s). The maximum duration of intraoral use of all members of the BoneTrust® Mini Implant System is 180 days

#### 4.1. Implants Description

The BoneTrust® Mini Implants are root form implants manufactured from commercially pure titanium (Grade 4) per ISO 5832-2 and are supplied either with a machined surface or a sand-blasted, acid-etched surface treatment. All BoneTrust® Mini Implant types feature an external torx connection for fitment of BoneTrust® Mini cement-type abutments or ball type attachments

The following types of BoneTrust® Mini Implants are available:

## BoneTrust® Mini implant

Image /page/5/Figure/8 description: The image shows a close-up of a dental implant. The implant is made of a metallic material and has a screw-like shape. The implant is designed to be inserted into the jawbone to support a dental prosthesis, such as a crown, bridge, or denture.

The BoneTrust® Mini Implant is a self-tapping straight body implant manufactured from commercially pure titanium with a machined surface. The implant features an external torx Implant-abutment connection.

## BoneTrust® Mini+ Implant

Image /page/5/Figure/11 description: The image shows a close-up of a dental implant. The implant is made of metal and has a screw-like shape. The top of the implant is smooth and rounded, while the bottom is threaded. The implant is designed to be inserted into the jawbone to support a dental prosthesis, such as a crown, bridge, or denture.

The BoneTrust® Mini+ Implant is a self-tapping tapered body implant manufactured from commercially pure titanium with a microstructured surface by means of sandblasting / acid-etching surface-treatment followed by passivation. The implant features an external torx Implant-abutment connection.

| Description | BoneTrust® Mini implant | BoneTrust® Mini+ Implant |
|-----------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Design / Shape | Screw type implant, straight Body, self-tapping | Screw type implant, tapered Body, self-tapping |
| Sizes - Diameter<br>x length (mm) | 2.3 x 11.5<br>2.3 x 13.0 | 2.5 x 10.0<br>2.5 x 13.0 |
| Cuff height (mm) | 2.25 | 3.50 |
| Material | Unalloyed titanium grade 4<br>(ISO 5832-2:1999 / ASTM F67-06:2006) | Unalloyed titanium grade 4<br>(ISO 5832-2:1999 / ASTM F67-06:2006) |
| Surface | Machined surface | Microstructured blasted etched surface passivated |
| Prosthetic Platform | Ball Attachment (Denture O-Ball),<br>Abutments for temporary cement-type restorations | Ball Attachment (Denture O-Ball),<br>Abutments for temporary cemented restorations |
| Abutment Connection | External Torx Connection | External Torx Connection |
| Packaging /<br>Sterilization | Sterile packed in blister; Sterilized by irradiation | Sterile packed in blister; Sterilized by irradiation |
| Duration of use | Max 180 days | Max 180 days |

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## 4.2. Abutments

BoneTrust® Mini Abutments are pre-manufactured single-piece Abutments directly connected to the BoneTrust® Mini Dental Implants and intended for use as an aid in the temporary prosthetic rehabilitation during the healing phase of permanent dental implants. BoneTrust® mini Abutments include Ball-type connections intended for support of removable overdentures and bridges as well as Cement-type connections for fixed temporary prosthetic restorations.

### 4.2.1. BoneTrust® Mini Esthetic Abutment

Image /page/6/Picture/5 description: The image shows a gray, cone-shaped object. The object appears to be made of a smooth material, possibly plastic or metal. The cone shape is wider at the bottom and tapers towards the top. There are some horizontal lines near the bottom of the cone, creating a layered effect.

The BoneTrust® Mini Esthetic Abutments are pre-manufactured Abutments manufactured from Ti-6Al-4V Alloy as per ISO 5832-3 / ASTM F136 standard. The Abutments are available in straight shape. They are characterized by an anatomical garland-shaped course which replaces the need for customization to a greatest possible extent. They are intended for single tooth restoration as well as bridge restorations. The abutment might be shortened up to a minimum abutment post height of 4 mm. The abutments are not intended for angular correction, correction of diameter or taper.

| Description | Mini Esthetic Abutment | | |
|----------------------------|------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|
| Angulation (°) | 0 | | |
| Available Sizes | Platform Diameter | Gingival Height (GH) | |
| | 2.7 mm | 1.0 mm | |
| Total Abutment Height [mm] | 5.5 | | |
| Design | External torx connection | | |
| Material | Titanium alloy Ti-6AI-4V (ISO 5832-3 / ASTM F136) | | |
| Surface | Machined | | |
| Packaging / Sterilization | packed in an individual PE bag - Must be sterilized by the user. | | |
| Duration of use | Max 180 days | | |
| End User Modification | Wall thickness/diameter | | No modifications allowed |
| | Post height | | Shortening to a minimum Abut-<br>ment Post Height of 4 mm al-<br>lowed |
| | Angulation and divergence | | No modifications allowed |
| | Gingival height | | No modifications allowed |
| | Connection platform | | No modifications allowed |
| | Method of modification | | Hand Tools only |

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## 4.2.2. BoneTrust® Mini Crown Base Abutment

Image /page/7/Figure/3 description: The image shows a close-up of a metal dental implant. The implant is cylindrical and has a series of threads running along its length. The threads are evenly spaced and appear to be designed to grip the bone. The implant has a smooth, polished surface and is likely made of titanium or a titanium alloy.

BoneTrust® Mini Crown Base Abutments are premanufactured Abutments manufactured from Ti-6Al-4V Alloy as per ISO 5832-3 / ASTM F136 standard. The Abutments are available in straight shape and intended to be used for dentures and screw retained bridge constructions. The abutment might be shortened up to a minimum abutment post height of 4 mm. The abutments are not intended for angular correction, correction of diameter or taper.

| Description | Mini Crown Base Abutment | | | |
|----------------------------|------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|--|
| Angulation (°) | 0 | | | |
| | Platform Diameter | Gingival Height (GH) | | |
| Available Sizes | 2.7 mm | 1.0 mm | | |
| Total Abutment Height [mm] | 7.5 | | | |
| Connection Type | External torx connection | | | |
| Material | Titanium alloy Ti-6Al-4V (ISO 5832-3 / ASTM F136) | | | |
| Surface | machined | | | |
| Packaging / Sterilization | packed in an individual PE bag - Must be sterilized by the user. | | | |
| Duration of use | Max 180 days | | | |
| | Wall thickness/diameter | | No modifications allowed | |
| | Post height | | Shortening to a minimum Abut-<br>ment Post Height of 4 mm al-<br>lowed | |
| End User Modification | Angulation and divergence | | No modifications allowed | |
| | Gingival height | | No modifications allowed | |
| | Connection platform | | No modifications allowed | |
| | Method of modification | | Hand Tools only | |

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#### 4.2.3. BoneTrust® Mini Ball-Attachments

Image /page/8/Picture/3 description: The image shows a dental implant and its abutment. The implant is a screw-shaped device that is surgically placed into the jawbone to support a dental prosthesis, such as a crown, bridge, or denture. The abutment is a connector that attaches to the implant and provides a base for the prosthesis. The implant and abutment are made of titanium, a biocompatible material that is well-tolerated by the body. The implant has a rough surface to promote bone growth and integration, while the abutment has a smooth surface to prevent plaque accumulation.

BoneTrust® Mini Ball-Attachments are indicated for the use of temporary nonsplinted, removable dentures in the treatment of partially or totally edentulous patients to restore chewing function. They consist of the Ball type Attachment and the O-Ring matrix. The Ball type Attachment is manufactured from Ti-6Al-4V Alloy as per ISO 5832-3 / ASTM F136 standard with a machined surface. This attachment is mounted on the implant by a screw-locking mechanism and serves as the male part of the removable BoneTrust® Mini Ball-Attachment system. The retaining female counterpart, the O-rinq matrix is manufactured from Ti-6Al-4V Alloy as per ISO 5832-3 / ASTM F136 with a machined surface. The O-Ring matrix is incorporated into an existing prosthesis via polymerization, engages the outside of the ball shape and allows retention of the prosthesis to the denture.

All components of the BoneTrust® Mini Ball-Attachment Abutments are not intended for any kind of modification by the user.

| Description | Mini Ball-Attachments |
|---------------------------|------------------------------------------------------------------|
| Angulation (°) | 0 |
| Platform diameter (mm) | 2.7 |
| Body diameter (mm) | 2.3 |
| Connection Type | Internal locking screw fixation |
| Material | Titan Grade 5 (ISO 5832-3 / ASTM F136) |
| Surface | machined |
| Packaging / Sterilization | packed in an individual PE bag - Must be sterilized by the user. |
| Duration of use | Max 180 days |

#### 4.3. BoneTrust® Mini Retaining Screw

Image /page/8/Picture/8 description: The image shows a close-up of a small, metallic screw. The screw has a cylindrical head and a threaded shaft. The metal appears to be a light gray color. The screw is likely used for fastening or joining materials together.

The BoneTrust® Mini Retaining Screw is manufactured from Ti-6Al-4V Alloy as per ISO 5832-3 / ASTM F136 standard with a machined surface. It is used to firmly connect BoneTrust® Mini Abutments with BoneTrust® Mini Implants via the implant's and abutment's torx-connection.

The BoneTrust® Mini Retaining Screw is delivered sterile and supplied with each BoneTrust® Mini Implant.

The BoneTrust® Mini Retaining Screw is not intended for any kind of modification by the user.

| Description | Mini Retaining Screw |
|---------------------------|------------------------------------------------------|
| Angulation (°) | 0 |
| Total Length (mm) | 4.4 |
| Diameter (mm) | 1.8 |
| Connection Type | M1,4x0,25 |
| Material | Titanium alloy Ti-6AI-4V (ISO 5832-3 / ASTM F136) |
| Surface | machined |
| Packaging / Sterilization | Sterile packed in blister; Sterilized by irradiation |
| Duration of use | Max 180 days |

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#### 5. Indications for Use

The BoneTrust® Mini and Mini+ Implants are intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implant(s). Use of BoneTrust® Mini and Mini+ Implants is not to exceed one hundred and eighty (180) days.

BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments are intended for use with BoneTrust® Mini / Mini+ Dental Implants to provisional prosthetic reconstructions during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments is not to exceed one hundred and eighty (180) days.

BoneTrust® Mini Ball Attachments are intended to be used with BoneTrust® Mini / Mini+ Dental Implants to support and/or retain provisional removable dental prostheses during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Ball Attachments is not to exceed one hundred and eighty (180) days.

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Image /page/10/Picture/1 description: The image shows the logo for "medical instinct". The words are in gray, except for the plus sign in the middle, which is orange. The logo also includes a registered trademark symbol in the upper right corner.

#### 6. Technological Characteristics and Substantial Equivalence

## 6.1. Comparison of indications for use and Technological Characteristics

The indications for use as well as technologics of the proposed devices are compared to the primary predicate and reference devices in the following tables:

| Company | Proposed Device:<br>Medical Instinct Deutsch-<br>land GmbH | Primary Predicate De-<br>vice:<br>Hiossen Inc. | Reference Device:<br>Sterngold | Reference Device:<br>Medical Instinct Deutsch-<br>land GmbH | Reference Device:<br>OSSTEM Implant Co.<br>Ltd. | Result |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Name | BoneTrust® Mini / Mini+<br>Implant System | EM Provisional | Sterngold 2.2mm Angled<br>Micro ERA Dental Implant<br>System | BoneTrust® Implant Sys-<br>tems | MS SA Implant System,<br>Type: Narrow ridge | -- |
| 510(K)<br>number | -- | K191751 | K092434 | K182313 | K122171 | -- |
| Intended<br>use | The BoneTrust® Mini and<br>Mini+ Implants are intended<br>to be loaded immediately in<br>partially or fully edentulous<br>mandibles and maxilla to<br>serve as temporary support<br>for provisional prosthetic<br>device during the healing<br>phase of permanent endos-<br>seous dental implant(s). Use<br>of BoneTrust® Mini and<br>Mini+ Implants is not to<br>exceed one hundred and<br>eighty (180) days. | The EM Provisional is<br>intended to be loaded<br>immediately in partially or<br>fully edentulous mandibles<br>and maxilla to serve as<br>temporary support for<br>provisional prosthetic<br>device during the healing<br>phase of permanent en-<br>dosseous dental im-<br>plant(s). | The Sternqold 2.2mm Angled<br>ERA dental implants are intend-<br>ed for long term as well as<br>temporary surgical implantation<br>in the bone of the patient's upper<br>or lower arch to provide immedi-<br>ate load or delayed load of<br>prosthetic systems, such as<br>artificial teeth, in order to restore<br>the patient's chewing function.<br>Immediate loading of the ERA<br>Implant should only occur when<br>the position of the implants<br>provides adequate bone quantity<br>and quality to allow proper<br>immediate mechanical stabiliza-<br>tion of the self-tapping screw<br>into the bone and where occlu-<br>sal and lateral forces can be<br>limited with appropriate occlusal<br>design and a soft diet. | Bone Trust® Dental Im-<br>plants are medical devices<br>intended to be surgically<br>placed in the bone of the<br>maxillary and/or mandibular<br>arches to provide support for<br>prosthetic restorations<br>(crowns, bridges or overden-<br>ture) in edentulous or partial-<br>ly edentulous patients to<br>restore a patients' chewing<br>function.<br>Bone Trust® Dental Im-<br>plants are in-tended for<br>immediate or delayed load-<br>ing after 12 weeks. | The MIS SA Implant (Nar-<br>row Ridge) is intended to<br>use in the treatment of<br>missing mandibular central<br>and lateral incisors to<br>support prosthetic device;<br>such as artificial teeth, in<br>order to restore chewing<br>function in partially eden-<br>tulous patients. The MIS<br>SA Implant (Narrow<br>Ridge) is intended for<br>single use only. It is in-<br>tended for delayed loading | Similar to primary<br>predicate device.<br>The primary predi-<br>cate device contains<br>limitations of implant<br>duration in the label-<br>ing.<br>The additional limita-<br>tion of implant dura-<br>tion is similar to<br>reference devices<br>and does not change<br>the intended use of<br>the device |

## 6.1.1. BoneTrust® Mini / Mini+ Implants

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Image /page/11/Picture/1 description: The image shows the logo for "medical instinct". The words are in lowercase letters and are gray, except for the plus sign between "ins" and "tinct", which is orange. A small "®" symbol is located to the right of the word "instinct".

| Company | Proposed Device:<br>Medical Instinct Deutsch-<br>land GmbH | Primary Predicate De-<br>vice:<br>Hiossen Inc. | Reference Device:<br>Sterngold | Reference Device:<br>Medical Instinct Deutsch-<br>land GmbH | Reference Device:<br>OSSTEM Implant Co.<br>Ltd. | Result |
|--------------------------------------|------------------------------------------------------------|------------------------------------------------|--------------------------------------------|-------------------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implant<br>material | Titanium Grade 4 ASTM<br>F67 | Titanium Grade 4 ASTM<br>F67 | Commercially pure Titanium | Titanium Grade 4 ASTM<br>F67 | Titanium Alloy Ti-6Al-4V<br>(ASTM F 136) | Identical to reference<br>device K182313 |
| Implant<br>Type | Screw-type | Screw-type | Screw-type | Screw-type | Screw-type | Identical |
| Design | straight body / tapered Body | straight body | straight body | straight body / tapered body | straight body | Identical to reference<br>device K182313 |
| Screw type | Self-tapping | Self-tapping | Self-tapping | Self-tapping | Self-tapping | Identical |
| Distal End | With thread | With thread | With thread | With thread | With thread | Identical |
| Single or<br>two piece | Two piece design | One piece design | Two piece design | Two piece design | One piece design | Identical to reference<br>devices K092434<br>and K182313 |
| Implant to<br>abutment<br>connection | Eternal Torx Implant / Abut-<br>ment fixture | Not applicable (One piece<br>design) | External hex Implant / Abutment<br>fixture | Cylindrical Internal Hexagon<br>or and conical torx | Not applicable (One piece<br>design) | The implant-<br>Abutment connection<br>geometry does not<br>raise any concerns in<br>regard to safety and<br>effectiveness of the<br>implant abutment<br>interface |

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Image /page/12/Picture/1 description: The image shows the logo for "medical instinct". The words are in lowercase letters and gray. The plus sign in the middle of the word "instinct" is orange. There is a registered trademark symbol in the upper right corner of the logo.

| Company | Proposed Device:<br>Medical Instinct Deutsch-<br>land GmbH | Primary Predicate De-<br>vice:<br>Hiossen Inc. | Reference Device:<br>Sterngold | Reference Device:<br>Medical Instinct Deutsch-<br>land GmbH | Reference Device:<br>OSSTEM Implant Co.<br>Ltd. | Result |
|-------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Implant<br>Dimensions<br>(Diameter X<br>Length) | Ø2.3 X 11.5<br>Ø2.3 X 13.0<br>Ø2.5 X 10.0<br>Ø2.5 X 13.0 | Ø1.8 mm X 10.0 mm<br>Ø1.8 mm X 13.0 mm<br>Ø1.8 mm X 15.0 mm<br>Ø2.5 mm X 10.0 mm<br>Ø2.5 mm X 13.0 mm<br>Ø2.5 mm X 15.0 mm | Ø2.2 mm X 10.0 mm<br>Ø2.2 mm X 13.0 mm<br>Ø2.2 mm X 15.0 mm | Ø3.4 X 8<br>Ø3.4 X 10<br>Ø3.4 X 11,5<br>Ø3.4 X 13<br>Ø3.4 X 14,5<br>Ø4 X 6.5<br>Ø4 X 8<br>Ø4 X 10<br>Ø4 X 11.5<br>Ø4 X 13<br>Ø4 X 14.5<br>Ø5 X 6.5<br>Ø5 X 8<br>Ø5 X 10<br>Ø5 X 11.5<br>Ø5 X 13 | Ø2.5 mm X 8.5 mm<br>Ø2.5 mm X 10.0 mm<br>Ø2.5 mm X 11.5 mm<br>Ø2.5 mm X 13.0 mm<br>Ø2.9 mm X 8.5 mm<br>Ø2.9 mm X 10.0 mm<br>Ø2.9 mm X 11.5 mm<br>Ø2.9 mm X 13.0 mm | Sizes are within<br>range of primary<br>predicate device |
| Surface<br>treatment | Machined /<br>Microstructured blasted<br>etched surface passivated | Machined | Microstrucured, acid-etched<br>Surface | Microstructured blasted<br>etched surface, passivated | Sand blasting and acid<br>etching | Identical to K191751<br>and K182313 |
| Sterilization | Beta Radiation | Gamma Radiation | Gamma Radiation | Beta Radiation | Radiation sterile | Identical to K182313 |

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| Company | Candidate:<br>Medical Instinct Deutschland<br>GmbH | Reference Device:<br>Nobel Biocare AB | Reference Device:<br>Sterngold | Reference Device:<br>Medical Instinct Deutschland<br>GmbH | Result |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | BoneTrust® Mini Esthetic Abut-<br>ments, Crown Base Abutments | Temporary Snap Abutment | Sterngold 2.2mm Angled Micro<br>ERA Dental Implant System | BoneTrust® Esthetic Abutments | -- |
| Code | NHA | NHA | DZE | NHA | -- |
| 510(K) number | -- | K161435 | K092434 | K182313 | -- |
| Indications | BoneTrust® Mini Esthetic abutments<br>and BoneTrust® Mini Crown Base<br>Abutments are intended for use with<br>BoneTrust® Mini / Mini+ Dental<br>Implants to provide support for<br>provisional prosthetic reconstruc-<br>tions during the healing phase of<br>permanent endosseous dental<br>implants. Use of BoneTrust® Mini<br>Esthetic abutments and BoneTrust®<br>Mini Crown Base Abutments is not<br>to exceed one hundred and eighty<br>(180) days. | The Temporary Snap Abutment is<br>intended to be used to fabricate<br>and support provisional restora-<br>tions that aid in creating an esthetic<br>emergence through the gingiva<br>during the healing period and prior<br>to final restoration. The Temporary<br>Snap Abutment can be used for<br>cement retained or screw-retained<br>provisional restorations. The abut-<br>ments can be used for single-unit<br>and multi-unit restorations. Use of<br>the temporary Snap Abutment is<br>not to exceed one hundred and<br>eighty (180) days. | The Sterngold 2.2mm Angled ERA<br>dental implants are intended for<br>long term as well as temporary<br>surgical implantation in the bone of<br>the patient's upper or lower arch to<br>provide immediate load or delayed<br>load of prosthetic systems, such as<br>artificial teeth, in order to restore<br>the patient's chewing function.<br>Immediate loading of the ERA<br>Implant should only occur when the<br>position of the implants provides<br>adequate bone quantity and quality<br>to allow proper immediate mechan-<br>ical stabilization of the self-tapping<br>screw into the bone and where<br>occlusal and lateral forces can be<br>limited with appropriate occlusal<br>design and a soft diet. | Bone Trust® Abutments and Pros-<br>thetic parts are intended for use<br>with Bone Trust Dental Implants in<br>the maxillary and/or mandibular<br>arches to provide support for<br>crowns, bridges or overdenture for<br>edentulous or partially edentulous<br>patients. | Substantially<br>Equivalent to<br>K161435.<br>Indications of<br>K092434 include<br>temporary and<br>permanent use and<br>thus cover all indi-<br>cations claimed for<br>the proposed de-<br>vice. The more<br>restrictive indica-<br>tions of the pro-<br>posed device do<br>not raise any con-<br>cerns in regard to<br>safety and effec-<br>tiveness<br>Minor differences in<br>language do not<br>impact the safety<br>and effectiveness<br>of the subject de-<br>vice |
| Company | Candidate:<br>Medical Instinct Deutschland<br>GmbH | Reference Device:<br>Nobel Biocare AB | Reference Device:<br>Sterngold | Reference Device:<br>Medical Instinct Deutschland<br>GmbH | Result |
| Duration of use | Temporary use | Temporary use | Temporary use / Permanent use | Permanent use | Identical to<br>K161435<br>Indications of<br>K092434 include<br>temporary and<br>permanent use and<br>thus cover all indi-<br>cations claimed for<br>the proposed de-<br>vice. The more<br>restrictive indica-<br>tions of the pro-<br>posed device do<br>not raise any con-<br>cerns in regard to<br>safety and effec-<br>tiveness |
| Material | Titanium alloy Ti6AI4V (ASTM F136) | Abutments and screws -<br>Titanium vanadium alloy<br>(ASTM F1472, ASTM F136) | Wrought Titanium<br>6AL-4V ELI | Titanium alloy Ti6AI4V<br>(ASTM F136) | Identical |
| Surface | Machined | Machined | Machined | Machined | Identical |
| Size | Platform Diameter: 2.7mm<br>Body Diameter: 3.9mm, 4.2mm<br>Gingival Height: 1.0mm | Platform Diameter: Narrow Plat-<br>form (NP), Regular Platform (RP),<br>Wide Platform (WP)<br>Body Diameter: 4.0, 4.5, 6.0mm<br>Collar height: 1.5mm, 3mm | Platform Diameter: 2.2mm (Implant<br>thread major diameter)<br>Cuff Height: 0,76 – 4mm | Platform Diameter: ø 3.4 - 4.0 -<br>5.0mm<br>Body Diameter: 4.5mm<br>Gingival Height: 0.5 - 0.7 - 2.5 -<br>4.5mm | Reference device<br>K092434 has been<br>used to address<br>any dimensions not<br>cleared in the<br>reference Device<br>K161435 submis-<br>sion. |
| Company | Candidate:<br>Medical Instinct Deutschland<br>GmbH | Reference Device:<br>Nobel Biocare AB | Reference Device:<br>Sterngold | Reference Device:<br>Medical Instinct Deutschland<br>GmbH | Result…