(435 days)
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.
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.
The provided text describes a 510(k) premarket notification for the BoneTrust® Mini Implant System. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a new device meets specific performance acceptance criteria through the types of studies typically conducted for novel AI/ML-driven medical devices.
Therefore, the requested information about acceptance criteria tables, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment is not present in this document. This document primarily relies on a comparative analysis of:
-
Indications for Use: The BoneTrust® Mini Implant System's intended use is compared to that of primary and reference predicate devices (EM Provisional, Sterngold 2.2mm Angled Micro ERA Dental Implant System, BoneTrust® Implant Systems, MIS LOCKIT Abutments System, Nobel Biocare AB, OSSTEM Implant Co. Ltd.). The conclusion is that the indications are "Similar to primary predicate device" or "Substantially Equivalent." The additional limitation of implant duration (max 180 days) is noted as not changing the intended use.
-
Technological Characteristics: Detailed comparisons are made regarding:
- Implant Material: Titanium Grade 4 ASTM F67, identical to reference device K182313.
- Implant Type and Design: Screw-type, straight body/tapered body, self-tapping, with thread, two-piece design. Largely identical or similar to predicate/reference devices.
- Implant-Abutment Connection: External Torx Implant/Abutment fixture. Differences from some predicates (one-piece design or different connection types) are stated not to raise concerns regarding safety and effectiveness.
- Implant Dimensions: The proposed device's sizes (diameters and lengths) are stated to be "within range of primary predicate device."
- Surface Treatment: Machined / Microstructured blasted etched surface passivated, stated as identical to K191751 and K182313.
- Sterilization: Beta Radiation, identical to K182313.
- Abutment Material, Surface, Size, Connection, Angulation, and Sterility: Comparisons are made to various predicate/reference abutments, with conclusions of "Identical" or minor differences not raising safety/effectiveness concerns.
- Ball Attachment Material, Surface, Size, Connection, Angulation, and Sterility: Similar comparisons are made, concluding "Identical" or differences not impacting safety/effectiveness.
-
Non-Clinical Testing Summary:
- Clinical Studies: None were performed.
- Biocompatibility: Relied on previous clearance of BoneTrust® Implant System (K182313) due to identical manufacturing process and materials. Periodic bacterial endotoxin testing (USP <85>) is performed, with historical data showing acceptable levels.
- Fatigue Testing: Not deemed necessary as per FDA Guidance Document for Class II Special Controls, because the system does not contain angulated abutments.
- Sterilization: Beta-radiation sterilized (SAL 10⁻⁶) according to ISO 11137-1:2006 and 11137-2:2013. Efficacy reliant on K182313 due to identical process. Unsterile prosthetic components are intended for end-user sterilization, with methods identical to K182313.
- Shelf Life: 5 years, reliant on K182313 due to identical packaging system.
- Implant Surface Analysis: Energy Dispersive X-ray Spectroscopy (EDX) and SEM analysis were conducted, and results support substantial equivalence to legally marketed predicate devices.
In summary, there is no study described in this document that proves the device meets specific acceptance criteria in the manner requested, because the submission focuses on demonstrating substantial equivalence to existing devices through comparative analysis and non-clinical testing rather than de novo clinical or performance studies with defined acceptance criteria for a novel AI/ML device.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.: +49 5593 95196 Fax.: +49 5593 95195
E-Mail: info@medical-instinct.de Internet: www.medical-instinct.de
CONTACT PERSON: Jan Worlitz Managing Director Tel.: +49 5593 95196 E-Mail: worlitz@medical-instinct.de
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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 - Diameterx length (mm) | 2.3 x 11.52.3 x 13.0 | 2.5 x 10.02.5 x 13.0 |
| Cuff height (mm) | 2.25 | 3.50 |
| Material | Unalloyed titanium grade 4(ISO 5832-2:1999 / ASTM F67-06:2006) | Unalloyed titanium grade 4(ISO 5832-2:1999 / ASTM F67-06:2006) |
| Surface | Machined surface | Microstructured blasted etched surface passivated |
| Prosthetic Platform | Ball Attachment (Denture O-Ball),Abutments for temporary cement-type restorations | Ball Attachment (Denture O-Ball),Abutments for temporary cemented restorations |
| Abutment Connection | External Torx Connection | External Torx Connection |
| Packaging /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-ment Post Height of 4 mm al-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-ment Post Height of 4 mm al-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:Medical Instinct Deutsch-land GmbH | Primary Predicate De-vice:Hiossen Inc. | Reference Device:Sterngold | Reference Device:Medical Instinct Deutsch-land GmbH | Reference Device:OSSTEM Implant Co.Ltd. | Result |
|---|---|---|---|---|---|---|
| DeviceName | BoneTrust® Mini / Mini+Implant System | EM Provisional | Sterngold 2.2mm AngledMicro ERA Dental ImplantSystem | BoneTrust® Implant Sys-tems | MS SA Implant System,Type: Narrow ridge | -- |
| 510(K)number | -- | K191751 | K092434 | K182313 | K122171 | -- |
| Intendeduse | The BoneTrust® Mini andMini+ Implants are intendedto be loaded immediately inpartially or fully edentulousmandibles and maxilla toserve as temporary supportfor provisional prostheticdevice during the healingphase of permanent endos-seous dental implant(s). Useof BoneTrust® Mini andMini+ Implants is not toexceed one hundred andeighty (180) days. | The EM Provisional isintended to be loadedimmediately in partially orfully edentulous mandiblesand maxilla to serve astemporary support forprovisional prostheticdevice during the healingphase of permanent en-dosseous dental im-plant(s). | The Sternqold 2.2mm AngledERA dental implants are intend-ed for long term as well astemporary surgical implantationin the bone of the patient's upperor lower arch to provide immedi-ate load or delayed load ofprosthetic systems, such asartificial teeth, in order to restorethe patient's chewing function.Immediate loading of the ERAImplant should only occur whenthe position of the implantsprovides adequate bone quantityand quality to allow properimmediate mechanical stabiliza-tion of the self-tapping screwinto the bone and where occlu-sal and lateral forces can belimited with appropriate occlusaldesign and a soft diet. | Bone Trust® Dental Im-plants are medical devicesintended to be surgicallyplaced in the bone of themaxillary and/or mandibulararches to provide support forprosthetic restorations(crowns, bridges or overden-ture) in edentulous or partial-ly edentulous patients torestore a patients' chewingfunction.Bone Trust® Dental Im-plants are in-tended forimmediate or delayed load-ing after 12 weeks. | The MIS SA Implant (Nar-row Ridge) is intended touse in the treatment ofmissing mandibular centraland lateral incisors tosupport prosthetic device;such as artificial teeth, inorder to restore chewingfunction in partially eden-tulous patients. The MISSA Implant (NarrowRidge) is intended forsingle use only. It is in-tended for delayed loading | Similar to primarypredicate device.The primary predi-cate device containslimitations of implantduration in the label-ing.The additional limita-tion of implant dura-tion is similar toreference devicesand does not changethe intended use ofthe 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:Medical Instinct Deutsch-land GmbH | Primary Predicate De-vice:Hiossen Inc. | Reference Device:Sterngold | Reference Device:Medical Instinct Deutsch-land GmbH | Reference Device:OSSTEM Implant Co.Ltd. | Result |
|---|---|---|---|---|---|---|
| Implantmaterial | Titanium Grade 4 ASTMF67 | Titanium Grade 4 ASTMF67 | Commercially pure Titanium | Titanium Grade 4 ASTMF67 | Titanium Alloy Ti-6Al-4V(ASTM F 136) | Identical to referencedevice K182313 |
| ImplantType | 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 referencedevice 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 ortwo piece | Two piece design | One piece design | Two piece design | Two piece design | One piece design | Identical to referencedevices K092434and K182313 |
| Implant toabutmentconnection | Eternal Torx Implant / Abut-ment fixture | Not applicable (One piecedesign) | External hex Implant / Abutmentfixture | Cylindrical Internal Hexagonor and conical torx | Not applicable (One piecedesign) | The implant-Abutment connectiongeometry does notraise any concerns inregard to safety andeffectiveness of theimplant abutmentinterface |
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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:Medical Instinct Deutsch-land GmbH | Primary Predicate De-vice:Hiossen Inc. | Reference Device:Sterngold | Reference Device:Medical Instinct Deutsch-land GmbH | Reference Device:OSSTEM Implant Co.Ltd. | Result |
|---|---|---|---|---|---|---|
| ImplantDimensions(Diameter XLength) | Ø2.3 X 11.5Ø2.3 X 13.0Ø2.5 X 10.0Ø2.5 X 13.0 | Ø1.8 mm X 10.0 mmØ1.8 mm X 13.0 mmØ1.8 mm X 15.0 mmØ2.5 mm X 10.0 mmØ2.5 mm X 13.0 mmØ2.5 mm X 15.0 mm | Ø2.2 mm X 10.0 mmØ2.2 mm X 13.0 mmØ2.2 mm X 15.0 mm | Ø3.4 X 8Ø3.4 X 10Ø3.4 X 11,5Ø3.4 X 13Ø3.4 X 14,5Ø4 X 6.5Ø4 X 8Ø4 X 10Ø4 X 11.5Ø4 X 13Ø4 X 14.5Ø5 X 6.5Ø5 X 8Ø5 X 10Ø5 X 11.5Ø5 X 13 | Ø2.5 mm X 8.5 mmØ2.5 mm X 10.0 mmØ2.5 mm X 11.5 mmØ2.5 mm X 13.0 mmØ2.9 mm X 8.5 mmØ2.9 mm X 10.0 mmØ2.9 mm X 11.5 mmØ2.9 mm X 13.0 mm | Sizes are withinrange of primarypredicate device |
| Surfacetreatment | Machined /Microstructured blastedetched surface passivated | Machined | Microstrucured, acid-etchedSurface | Microstructured blastedetched surface, passivated | Sand blasting and acidetching | Identical to K191751and K182313 |
| Sterilization | Beta Radiation | Gamma Radiation | Gamma Radiation | Beta Radiation | Radiation sterile | Identical to K182313 |
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| Company | Candidate:Medical Instinct DeutschlandGmbH | Reference Device:Nobel Biocare AB | Reference Device:Sterngold | Reference Device:Medical Instinct DeutschlandGmbH | Result |
|---|---|---|---|---|---|
| Device Name | BoneTrust® Mini Esthetic Abut-ments, Crown Base Abutments | Temporary Snap Abutment | Sterngold 2.2mm Angled MicroERA Dental Implant System | BoneTrust® Esthetic Abutments | -- |
| Code | NHA | NHA | DZE | NHA | -- |
| 510(K) number | -- | K161435 | K092434 | K182313 | -- |
| Indications | BoneTrust® Mini Esthetic abutmentsand BoneTrust® Mini Crown BaseAbutments are intended for use withBoneTrust® Mini / Mini+ DentalImplants to provide support forprovisional prosthetic reconstruc-tions during the healing phase ofpermanent endosseous dentalimplants. Use of BoneTrust® MiniEsthetic abutments and BoneTrust®Mini Crown Base Abutments is notto exceed one hundred and eighty(180) days. | The Temporary Snap Abutment isintended to be used to fabricateand support provisional restora-tions that aid in creating an estheticemergence through the gingivaduring the healing period and priorto final restoration. The TemporarySnap Abutment can be used forcement retained or screw-retainedprovisional restorations. The abut-ments can be used for single-unitand multi-unit restorations. Use ofthe temporary Snap Abutment isnot to exceed one hundred andeighty (180) days. | The Sterngold 2.2mm Angled ERAdental implants are intended forlong term as well as temporarysurgical implantation in the bone ofthe patient's upper or lower arch toprovide immediate load or delayedload of prosthetic systems, such asartificial teeth, in order to restorethe patient's chewing function.Immediate loading of the ERAImplant should only occur when theposition of the implants providesadequate bone quantity and qualityto allow proper immediate mechan-ical stabilization of the self-tappingscrew into the bone and whereocclusal and lateral forces can belimited with appropriate occlusaldesign and a soft diet. | Bone Trust® Abutments and Pros-thetic parts are intended for usewith Bone Trust Dental Implants inthe maxillary and/or mandibulararches to provide support forcrowns, bridges or overdenture foredentulous or partially edentulouspatients. | SubstantiallyEquivalent toK161435.Indications ofK092434 includetemporary andpermanent use andthus cover all indi-cations claimed forthe proposed de-vice. The morerestrictive indica-tions of the pro-posed device donot raise any con-cerns in regard tosafety and effec-tivenessMinor differences inlanguage do notimpact the safetyand effectivenessof the subject de-vice |
| Company | Candidate:Medical Instinct DeutschlandGmbH | Reference Device:Nobel Biocare AB | Reference Device:Sterngold | Reference Device:Medical Instinct DeutschlandGmbH | Result |
| Duration of use | Temporary use | Temporary use | Temporary use / Permanent use | Permanent use | Identical toK161435Indications ofK092434 includetemporary andpermanent use andthus cover all indi-cations claimed forthe proposed de-vice. The morerestrictive indica-tions of the pro-posed device donot raise any con-cerns in regard tosafety and effec-tiveness |
| Material | Titanium alloy Ti6AI4V (ASTM F136) | Abutments and screws -Titanium vanadium alloy(ASTM F1472, ASTM F136) | Wrought Titanium6AL-4V ELI | Titanium alloy Ti6AI4V(ASTM F136) | Identical |
| Surface | Machined | Machined | Machined | Machined | Identical |
| Size | Platform Diameter: 2.7mmBody Diameter: 3.9mm, 4.2mmGingival Height: 1.0mm | Platform Diameter: Narrow Plat-form (NP), Regular Platform (RP),Wide Platform (WP)Body Diameter: 4.0, 4.5, 6.0mmCollar height: 1.5mm, 3mm | Platform Diameter: 2.2mm (Implantthread major diameter)Cuff Height: 0,76 – 4mm | Platform Diameter: ø 3.4 - 4.0 -5.0mmBody Diameter: 4.5mmGingival Height: 0.5 - 0.7 - 2.5 -4.5mm | Reference deviceK092434 has beenused to addressany dimensions notcleared in thereference DeviceK161435 submis-sion. |
| Company | Candidate:Medical Instinct DeutschlandGmbH | Reference Device:Nobel Biocare AB | Reference Device:Sterngold | Reference Device:Medical Instinct DeutschlandGmbH | Result |
| Connection | Eternal Torx Implant / Abutmentfixture | Internal conical connection | Internal Connection | Cylindrical external Hexagon orconical torx | The implant-Abutment connec-tion geometry doesnot raise any con-cerns in regard tosafety and effec-tiveness of theimplant abutmentinterface |
| Angulation | 0° | 0° | 0°, 5°, 11°, 17° | 0° - 15° - 20° | Identical toK161435 |
| sterility | Unsterile | Unsterile | Unsterile | Unsterile | Identical |
6.1.2. BoneTrust® Mini Esthetic Abutments / Mini Crown base Abutments
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Image /page/14/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".
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510(K) BoneTrust® Mini Implant System
Image /page/15/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".
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Image /page/16/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".
6.1.3. BoneTrust® Mini Ball Attachment
| Candidate: | Reference Device: | Result | |
|---|---|---|---|
| Company | Medical Instinct Deutschland GmbH | MIS Implants Technologies Ltd. | |
| Device Name | BoneTrust® Ball Attachments | MIS LOCKIT Abutments System, OT-Equators and Ball Attachments | -- |
| Code | NHA | NHA | -- |
| 510(K) number | -- | K182228 | -- |
| Indications | BoneTrust® Mini Ball Attachments are intended to beused with BoneTrust® Mini / Mini+ Dental Implants tosupport 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. | Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The abutments in combination with endosseous implants are used as the foundation for anchoring tooth replacements in either jaw. For fully edentulous jaw retaining a tissue-supported overdenture. | Both devices are intended for the support of removable dental prostheses.Reference Device is indicated for long-term intraoral use, whereas the proposed device is indicated for provisional use. These differences do not impact the safety and effectiveness of the proposed device |
| Material | Titanium alloy Ti6Al4V (ASTM F136) | Ti 6AI 4V ELI per ASTM F136 | Identical |
| Surface | machined | TiN coating after machined | Results of biocompatibility assessment and testing support that differences in surface treatment do not raise any concerns in regard to safety and effectiveness of the proposed device |
| Size | Platform Diameter: 2.7mmBody Diameter: 4.5mmGingival Height: 1.0mm | Platform Diameter: 3.3mm, 3.75mm, 4.2mm, 5.0mm, 6.0mmBody Diameter: 4.0mm, 4.1mm, 5.0mmGingival Height: 1.0mm, 2.0mm, 3.0mm, 4.0mm, 5.0mm | Platform Sizes are adapted to platform diameter of the implant system. Minor differences do not raise any concerns in regard to safety and effectiveness of the proposed device |
| Connection | Internal locking screw fixation | Internal hexagon | The implant-Abutment connection geometry does not raise any concerns in regard to safety and effectiveness of the implant abutment interface. |
| Angulation | 0° | 0° | Identical |
| sterility | Non Sterile | Non Sterile | Identical |
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7. Performance testing
Summary of Clinical Testing 7.1.
No clinical studies were performed for the BoneTrust® Mini Implant System
7.2. Summary of non-Clinical Testing
The following nonclinical testing data were provided or relied upon in support of the substantial equivalence determination.
7.2.1. Biocompatibility
BoneTrust® Mini Implants and prosthetic components are manufactured using the same manufacturing process and same well established materials as Implants and prosthetic components of the BoneTrust® Implant System previously cleared under #K182313. Therefore it is believed that additional biocompatibility testing in order to support the biological safety of the BoneTrust® Mini Implant System is not necessary.
7.2.1.1. Testing for Bacterial endotoxins
Periodic testing for bacterial endotoxins on BoneTrust® Mini Implants and prosthetic components is performed in accordance with USP <85> (limits 2.15 EU / sample). Historical test data has shown that BoneTrust® Mini implants continuously maintain acceptable levels of bacterial endotoxins. Therefore, a sampling plan including quarterly testing for endotoxins has been considered appropriate based on established process-consistency.
7.2.2. Fatigue testing.
The BoneTrust® Mini Implant system does not contain angulated abutments. As per FDA Guidance Document: Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments fating has not been deemed necessary to support substantial equivalence
7.2.3. Sterilization
The BoneTrust® Mini and Mini+ implants are Beta-radiation sterilized for a SAL (Sterility Assurance Level) of 10% with a validated sterilization procedure according to ISO 11137-1:2006 (Sterilization of health care products - Radiation - Part 1: Requirement, validation and routine control of a sterilization process for medical devices) and 11137-2:2013 (Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose).
The manufacturing, packaging and sterilization process applied to the BoneTrust® Mini Implants is identical to the sterilization process for BoneTrust® Implants previously cleared under #K182313. Therefore it is believed that no additional validation studies are necessary to support sterilization efficacy of the BoneTrust® Mini Implants.
BoneTrust® Mini prosthetic components are delivered unsterile and intended to be sterilized by the enduser prior to their clinical use. Device design as well as indicated methods and process-parameters for end-user sterilization are identical to BoneTrust® prosthetic components previously cleared under #K182313. Therefore it is believed that no additional validation studies are necessary to support end-user sterilization efficacy of the BoneTrust® Mini prosthetic components.
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7.2.4. Shelf life
BoneTrust® Mini and Mini+ Implants are delivered sterile with a shelf life of 5 years. The packaging system used for the BoneTrust® Mini Implants is identical to the packaging system used for the BoneTrust® implants previously cleared under #K182313. Therefore it is believed that no additional validation studies are necessary to support Shelf-Life of the BoneTrust® mini Implant packaging system. Instead, validation activities performed on the BoneTrust® Implants cleared under #K182313 apply to the BoneTrust® Mini Implants.
7.2.5. Implant Surface Analysis
BoneTrust® Mini and Mini+ Implants feature the same surface modification as BoneTrust® Implants, previously cleared under #K182313. Investigation of the implant surface included Energy Dispersive X-ray Spectroscopy (EDX) and SEM (Scanning Electron Microscopy) analysis. Results support substantial equivalence of the BoneTrust® Mini implants to legally marketed predicate devices.
8. Conclusion as to Substantial Equivalence:
Based on the comparison of the indications for use, the technological characteristics and the nonclinical testing it can be concluded that the BoneTrust® Mini Implant System is substantially equivalent to the predicate devices.
§ 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.