(196 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of dental implants and abutments, with no mention of AI or ML.
No
Explanation: The device is intended to restore chewing function by supporting prosthetic restorations, which is a supportive rather than a therapeutic action.
No
This device is a dental implant system intended for surgical placement to support prosthetic restorations, restoring chewing function; it does not diagnose any condition.
No
The device description clearly states it is a system of physical dental implants and abutments made of titanium, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the BoneTrust® Dental Implants are "medical devices intended to be surgically placed in the bone... to provide support for prosthetic restorations... to restore a patients' chewing function." This describes a device used in vivo (within the body) for a structural and functional purpose.
- Device Description: The description details the physical components of the implants and abutments, their materials, and their design for surgical placement and connection to prosthetics. This aligns with a surgical implant, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue), detecting specific substances, or providing information for diagnosis. IVDs are designed to perform tests on biological samples to provide diagnostic information.
In summary, the BoneTrust® Dental Implant System is a surgical medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BoneTrust® Dental Implants are medical devices intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function.
BoneTrust® implants can also be used for immediate loading when sufficient primary stability is achieved and with appropriate occlusal loading.
BoneTrust® Short Dental Implants with length 6.5 mm are intended for delayed loading only
BoneTrust® Abutments and Prosthetic parts are intended for use with Bone Trust Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdenture for edentulous or partially edentulous patients.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The BoneTrust® Implant System includes various sizes of threaded root-form dental implants and abutments intended to support prosthetic restorations in edentulous or partially edentulous patients.
Implants: The BoneTrust® Implants are bone level, root form implants constructed of commercially pure titanium (Grade 4) per ISO 5832-2, with a sand-blasted, acid-etched surface treatment. BoneTrust® Implants are screw- shaped dental implants with a Hexagon or conical torx internal connection.
Abutments: BoneTrust® Dental Abutments are intended for cement-retained and screw-retained restorations. A cylindrical internal hexagon or conical torx allows connection to the BoneTrust® implant. BoneTrust® Dental Abutments are available in different designs, including:
- Esthetic Abutments: Premanufactured single-piece abutments constructed of titanium alloy per ISO 5832-3 for cemented single-tooth and bridge restorations and temporary single tooth restorations.
- Wide Body Abutments: Premanufactured single-piece abutments constructed of titanium alloy per ISO 5832-3 for cemented single-tooth and bridge restorations and temporary single tooth restorations with a wider body diameter.
- UCLA Abutments: Intended as a pattern for customized veneered crowns for cemented or screw retained single-tooth and bridge restorations, made from precious alloys or non-precious alloys.
- Direct Abutment: Premanufactured multi-unit abutments constructed of titanium alloy per ISO 5832-3 for splinted and occlusally screwed prosthetics, such as bridges, hybrid prostheses and cast bars.
- AuroBase Direct Abutments: Premanufactured multi-unit abutments intended as a pattern for customized veneered crowns for splinted and occlusally screwed prosthetics, such as bridges, hybrid prostheses and cast bars. Made from precious alloys or non-precious alloys.
- Telescopic Abutment: Constructed of titanium alloy per ISO 5832-3 for fixation of friction retained removable restorations and bridges.
- Healing Abutment: Premanufactured abutments constructed of titanium alloy per ISO 5832-3 for temporary use during the healing period to prepare gingival tissue for the final abutment.
- Direct Healing Abutment: Premanufactured abutments made of titanium alloy per ISO 5832-3 for use with BoneTrust® Direct Abutments during the healing period.
- Healing Abutments Wide Body: Premanufactured abutments made of titanium alloy per ISO 5832-3 for use during the healing period with the BoneTrust® Implant System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Maxillary and/or mandibular arches
Indicated Patient Age Range
edentulous or partially edentulous patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data were provided or relied upon to support the substantial equivalence determination.
- Biocompatibility: Assessment performed according to ISO 10993 series, including testing for cytotoxicity according to ISO 10993-5. Results support substantial equivalence.
- Fatigue testing: Tested for representative samples in accordance with ISO 14801. Results support substantial equivalence.
- Sterilization: Validation for non-sterile devices conducted according to ISO 17665-1 and ISO 17665-2 for pre-vacuum steam sterilization (wrapped cycle), demonstrating a sterility assurance level (SAL) of 10-6. Validation for devices delivered sterile conducted according to ISO 11137-1 and 11137-2 for Beta-radiation sterilization. Shelf life testing according to ISO 11607-1 and ASTM F1980. LAL testing according to USP 85 and FDA Guidance.
- Implant Surface Analysis: Investigation included Energy Dispersive X-ray Spectroscopy (EDX), SEM (Scanning Electron Microscopy), and BSE (Back-Scattered-Electrons / secondary electrons analysis. Results support substantial equivalence.
- Non-clinical Performance Data BoneTrust® Short Implants: Comparative Surface area analysis, Comparative Bone-to-implant contact study using animal histology, Comparative pull-out strength test. Results support substantial equivalence.
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K083496, K072570, K041295, K113779, K130808, K173207, K072642, K021318, K171142
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
March 11, 2019
Medical Instinct Deutschland GmbH % Andre Weingerl RA Consultant WRC Consulting Am Hohsetter 1A Steislingen 78256 GERMANY
Re: K182313
Trade/Device Name: BoneTrust® Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 6, 2019 Received: February 13, 2019
Dear Andre 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.
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182313
Device Name BoneTrust® Implant System
Indications for Use (Describe)
BoneTrust® Dental Implants are medical devices intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function.
BoneTrust® implants can also be used for immediate loading when sufficient primary stability is achieved and with appropriate occlusal loading.
BoneTrust® Short Dental Implants with length 6.5 mm are intended for delayed loading only
BoneTrust® Abutments and Prosthetic parts are intended for use with Bone Trust Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdentulous or partially edentulous patients.
| 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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medical i
K182313
510(k) Summary
Date Prepared: 2019-03-09
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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medica
Device Name 1.
| Trade Names: | BoneTrust® Implant System |
|---|---|
| Classification Name: | Endosseous dental implant |
2. Classification Product Code / Subsequent Code
BoneTrust® 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
. Primary Predicate Device
Straumann Dental Implant System; Stramann USA, LLC
Reference Devices .
| CAMLOG Abutments; Altatec GmbH | #K083496 |
|---|---|
| Nobelactive Multi Unit Abutments; Nobel Biocare AB | #K072570 |
| Straumann RN synOcta UCLA Gold Abutment; Institut Straumann AG | #K041295 |
| Conelog Implant System; Altatec GmbH | #K113779 |
| STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS | #K130808 |
| SIC Invent Dental Implant Systems; SIC Invent AG | #K173207 |
| BIOMET 3i Dental Abutments | #K072642 |
| XIVE@ Dental Implant System | #K021318 |
| Healing Cap Multi-Unit Titanium, Nobel Biocare AB | #K171142 |
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Device Description 4.
The BoneTrust® Implant System includes various sizes of threaded root-form dental implants and abutments intended to support prosthetic restorations in edentulous or partially edentulous patients.
Implants 4.1.
The BoneTrust® Implants are bone level, root form implants constructed of commercially pure titanium (Grade 4) per ISO 5832-2, with a sand-blasted, acid-etched surface treatment. BoneTrust® Implants are screw- shaped dental implants with a Hexagon or conical torx internal connection.
Bone Trust Implants are provided in the following specifications:
| Representative Picture | Specification | Value |
|---|---|---|
| Image: Dental Implant | Sizes - Diameter x length | |
| (mm) | 3.4 x 8.0 / 3.4 x 10.0 / 3.4 x 11.5 / 3.4 x 13.0 / 3.4 x 14.5 | |
| 4.0 x 6.5 / 4.0 x 8.0 / 4.0 x 10.0 / 4.0 x 11.5 / 4.0 x 13.0 / | ||
| 4.0 x 14.5 | ||
| 5.0 x 6.5 / 5.0 x 8.0 / 5.0 x 10.0 / 5.0 x 11.5 / 5.0 x 13.0 | ||
| Design | Conical screw implant | |
| Self-tapping screw design | ||
| Integrated "platform switching" | ||
| Internal connection hexagonal / internal connection with conical torx socket | ||
| Material | Titan Grade 4 (ISO 5832-2:1999 / ASTM F67-06:2006) | |
| Surface | Micro-structured blasted etched surface passivated | |
| Packaging / Sterilization | Sterile packed in blister; Sterilized by beta irradiation |
4.2. Abutments
BoneTrust® Dental Abutments are intended for cement-retained and screw-retained restorations. A cylindrical internal hexagon or conical torx allows connection to the BoneTrust® implant. BoneTrust® Dental Abutments are available in different designs
4.2.1. Esthetic Abutments
BoneTrust® Esthetic and Wide Body Abutments are premanufactured single-piece abutments constructed of titanium alloy per ISO 5832-3 and intended to be used for cemented single-tooth and bridge restorations as well as temporary single tooth restorations. BoneTrust® Esthetic Abutments are available in the following shapes:
| Esthetic Abutments | |||
|---|---|---|---|
| Available sizes | Platform Diameter | Sizes (Angulation, Gingival Height (GH)) | |
| Ø3.4 | 0°: GH 0.5, 2.5, 4.5mm | ||
| 15°: GH 0.5, 2.5mm | |||
| 20°: GH 0.7mm | |||
| Ø4.0 | 0°: GH 0.5, 2.5, 4.5mm | ||
| 15°: GH 0.5, 2.5mm | |||
| Ø5.0 | 0°: GH 2.5mm | ||
| 15°: GH 0.5mm, 2.5mm | |||
| Total Abutment Height [mm] | 10.1 to 11.6 | ||
| Design | Hexagonal connection / conical torx socket connection | ||
| Material | Titan Grade 5 (ISO 5832-3 / ASTM F136) | ||
| Surface | Anodized |
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| Esthetic Abutments | |
|---|---|
| Packaging / Sterilization | |
| Packed in an individual PE bag - Must be sterilized by the user. | |
| End User Modification | Wall thickness/diameter |
| Post height | |
| Angulation and divergence | |
| Gingival height | |
| No modifications allowed | |
| Connection platform | |
| No modifications allowed | |
| Method of modification | |
| Hand Tools only |
Wide Body Abutments 4.2.2.
BoneTrust® Wide Body Abutments are premanufactured single-piece abutments constructed of titanium alloy per ISO 5832-3 and intended to be used for cemented single-tooth and bridge restorations as well as temporary single tooth restorations.
Wide Body Abutment and Wide Body Abutment cone+ feature bigger body diameter compared to the Esthetic Abutment / Esthetic Abutment cone+ which allows the option of switching to a wider prosthetic platform
The abutment might be shortened up to a minimum abutment post height of 5 mm. the abutments are not intended for angular correction, correction of diameter or taper
| Wide Body Abutments | |||
|---|---|---|---|
| Image: dental abutment | Angulation (°) | 0 | |
| Available Sizes | Platform Diameter | Gingival Height (GH) | |
| 3.4 mm / 4.0 mm | 3.0 mm | ||
| 5.0 mm | 3.0 mm | ||
| Total Abutment Height [mm] | 11.2 to 12.2 | ||
| Design | Hexagonal connection / conical torx socket connection | ||
| Material | Titan Grade 5 (ISO 5832-3 / ASTM F136) | ||
| Surface | Anodized | ||
| Packaging / Sterilization | Packed in an individual PE bag - Must be sterilized by the user. | ||
| End User Modification | Wall thickness/diameter | ||
| Post height | |||
| Angulation and divergence | |||
| Gingival height | |||
| Connection platform | |||
| Method of modification |
7
4.2.3. UCLA Abutments
BoneTrust® UCLA Abutments are intended to be used as a pattern for the creation of customized veneered crowns for cemented or screw retained single-tooth and bridge restorations. BoneTrust® UCLA Abutments are available in the following shapes:
| UCLA Abutments | ||
|---|---|---|
| Image: [abutments] | Angulation [°] | 0 |
| Platform Diameter [mm] | 3.4 / 4.0 / 5.0 | |
| Body Diameter [mm] | 2.8 | |
| Cylinder Height [mm] | 3.0 | |
| Design | Hexagonal connection with / without rotation stop | |
| Design | Conical torx socket connection with / without rotation stop | |
| Material for Precious Alloys | Heraplat Au 61%, Pt 23.8 %, Pd 15 %, Rh 0.2 % | |
| Material for Non Precious Alloys | PtIr20% (ISO 22674) | |
| Surface | Anodized | |
| Packaging / Sterilization | Packed in an individual PE bag - Must be sterilized by the user. | |
| End User Modification | No modification allowed to the abutment | |
| Burn-out plastic sleeve may be shortened down to a minimum height of 4 mm |
4.2.4. Direct Abutment
BoneTrust® Direct Abutments are premanufactured multi-unit abutments constructed of titanium alloy per ISO 5832-3 and intended to be used for splinted and occlusally screwed prosthetics, such as bridges, hybrid prostheses and cast bars,. BoneTrust® Direct Abutments are two piece abutments intended for use in combination with Auro Base Direct Abutments. BoneTrust® Direct Abutments are available in the following shapes:
| Direct Abutments | |||
|---|---|---|---|
| Available Sizes | Angulation | Size (diameter in mm x Gingival Height in mm) | |
| 0° | 3.4/4.0 x GH 1.0 | ||
| 3.4/4.0 x GH 3.0 | |||
| 20° | 3.4/4.0 x GH 2.0 | ||
| 30° | 3.4/4.0 x GH 2.0 | ||
| Total Abutment Height [mm] | 9.1 to 12.2 | ||
| Design | Hexagonal connection / conical torx socket connection | ||
| Material | Titan Grade 5 (ISO 5832-3 / ASTM F136) | ||
| Surface | Anodized | ||
| Compatible Abutments | BonteTrust® Direct Healing Abutments | ||
| BoneTrust® AuroBase Abutments | |||
| Packaging / Sterilization | packed in an individual PE bag - Must be sterilized by the user. | ||
| End User Modification | No modification allowed |
8
4.2.5. AuroBase Direct Abutments
BoneTrust® AuroBase Direct Abutments are premanufactured multi-unit abutments intended to be used as a pattern for the creation of customized veneered crowns for splinted and occlusally screwed prosthetics, such as bridges, hybrid prostheses and cast bars. BoneTrust® AuroBase Direct Abutments are two piece abutments intended for use in combination with Direct Abutments.
| Auro Base Abutment | ||
|---|---|---|
| Angulation (°) | 0 | |
| Cylinder Height (mm) | 3.2 | |
| Platform diameter D (mm) | 3.4 / 4.0 | |
| Body diameter (mm) | 3.15 | |
| Design | Hexagonal connection / conical torx socket connection | |
| Material for Precious Alloys | Heraplat Au 61%, Pt 23.8 %, Pd 15 %, Rh 0.2 % | |
| Material for Non Precious Alloys | Ptlr20% (ISO 22674) | |
| Surface | Anodized | |
| Compatible Abutments | BonteTrust® Direct Abutments | |
| Packaging / Sterilization | packed in an individual PE bag - Must be sterilized by the user. | |
| End User Modification | No modification allowed to the abutment | |
| Burn-out plastic sleeve may be shortened down to a minimum height of 4 mm |
4.2.6. Telescopic Abutment
BoneTrust® Telescopic Abutments are constructed of titanium alloy per ISO 5832-3 and intended to be used for fixation of friction retained removable restorations and bridges. BoneTrust® telescopic Abutments are available with hexagon or conical torx connection with 3.4 / 4 mm Platform.
| Telescopic Abutment | |||
|---|---|---|---|
| Angulation (°) | 0 | ||
| Platform diameter D (mm) | 3.4 / 4 | ||
| Body diameter (mm) | 5 | ||
| Total Abutment Height [mm] | 8.0 to 10.8 | ||
| Design | Hexagonal connection / conical torx socket connection | ||
| Material | Titan Grade 5 (ISO 5832-3 / ASTM F136) | ||
| Surface | Anodized | ||
| Packaging / Sterilization | packed in an individual PE bag - Must be sterilized by the user. | ||
| End User Modification | Wall thickness/diameter | No modifications allowed | |
| Post height | No modifications allowed | ||
| Angulation and divergence | Maximum Taper of 5° to correct diver-gence between implants | ||
| Gingival height | No modifications allowed | ||
| Connection platform | No modifications allowed | ||
| Method of modification | Hand Tools only |
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Healing Abutment 4.2.7.
BoneTrust® Healing Abutments are premanufactured abutments constructed of titanium alloy per ISO 5832-3 and intended to be used temporarily during the healing period of the BoneTrust® implant to prepare gingival tissue for acceptance of the final abutment. BoneTrust® Healing Abutments are available in the following shapes:
| Image: dental abutments | Healing Abutment | ||
|---|---|---|---|
| Angulation (°) | 0 | ||
| Available Sizes | Platform Diameter | Gingival Height (GH) | |
| 3.4 mm | 1.5 mm, 3.0 mm, 5.0 mm, 7.0 mm | ||
| 4.0 mm | 1.5 mm, 3.0 mm, 5.0 mm | ||
| 5.0 mm | 1.5 mm, 3.0 mm, 5.0 mm | ||
| Total Abutment Height [mm] | 6.5 to 12.6 | ||
| Design | Hexagonal connection / conical torx socket connection | ||
| Material | Titan Grade 5 (ISO 5832-3 / ASTM F136) | ||
| Surface | Anodized | ||
| Packaging / Sterilization | packed in an individual PE bag - Must be sterilized by the user. | ||
| Maximum intraoral Use | 180 Days | ||
| Load | Non-occlusal load |
Direct Healing Abutment 4.2.8.
BoneTrust® Direct Healing Abutments are premanufactured abutments designed to be mounted on BoneTrust® Direct Abutments. They are constructed of titanium alloy per ISO 5832-3 and indicated for use with the BoneTrust® Direct Abutments during the healing period of the BoneTrust® implant to prepare gingival tissue for acceptance of the final abutment. They are intended for use of up to 180 days during endosseous and gingival healing and are for non-occlusal restorations. BoneTrust® Direct Healing Abutments are available in the following shapes:
| Direct Healing Abutment | ||
|---|---|---|
| Image: Direct Healing Abutment | Angulation [°] | 0 |
| Diameter [mm] | 4.9 | |
| Length [mm] | 4.75 | |
| Material | Titan Grade 5 (ISO 5832-3 / ASTM F136) | |
| Surface | Anodized | |
| Packaging / Sterilization | Packed in an individual PE bag - Must be sterilized by the user. | |
| Maximum Intraoral Use | 180 Days | |
| Load | Non-occlusal load |
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4.2.9. Healing Abutments Wide Body
BoneTrust® Wide Body Healing Abutments are premanufactured abutments constructed of titanium alloy per ISO 5832-3 and indicated for use with the BoneTrust® Implant System during the healing period of the BoneTrust® implant to prepare gingival tissue for acceptance of the final abutment. They are intended for use of up to 180 days during endosseous and gingival healing and are for non-occlusal loading of provisional restorations. BoneTrust® Healing Abutments Wide Body are available in the following shapes:
| Healing Abutment - Wide Body | |||
|---|---|---|---|
| Image: dental abutments | Angulation (°) | 0 | |
| Image: dental abutments | Available Sizes | Platform Diameter | Gingival Height (GH) |
| 3.4 mm / 4.0 mm | 3.0 mm, 5.0 mm | ||
| 5.0 mm | 3.0 mm, 5.0 mm | ||
| Image: dental abutments | Total Abutment Height [mm] | 8.6 to 10.6 | |
| Image: dental abutments | Design | Hexagonal connection / conical torx socket connection | |
| Image: dental abutments | Material | Titan Grade 5 (ISO 5832-3 / ASTM F136) | |
| Image: dental abutments | Surface | Anodized | |
| Image: dental abutments | Packaging / Sterilization | packed in an individual PE bag - Must be sterilized by the user. | |
| Image: dental abutments | Maximum intraoral Use | 180 Days | |
| Image: dental abutments | Load | Non-occlusal load |
5. Indications for Use
BoneTrust® Dental Implants are medical devices intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function.
Bone Trust® implants can also be used for immediate loading when sufficient primary stability is achieved and with appropriate occlusal loading.
BoneTrust® Short Dental Implants with length 6.5 mm are intended for delayed loading only
BoneTrust® Abutments and Prosthetic parts are intended for use with Bone Trust Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdenture for edentulous or partially edentulous patients.
11
Technological Characteristics and Substantial Equivalence 6.
6.1. Comparison of Indications for Use
The indications for use of the subject devices are compared to the primary predicate and reference devices in the following tables:
| Candidate: | Primary Predicate: | Discussion | |
|---|---|---|---|
| Company | Medical Instinct Deutschland | ||
| GmbH | Straumann AG | ||
| Device | |||
| Name | BoneTrust® Implant System | Dental Implant System - Roxolid® | |
| SLA Implants | -- | ||
| 510(K) | |||
| number | -- | K150938 | -- |
| Indica- | |||
| tions for | |||
| Use | BoneTrust® Dental Implants are | ||
| medical devices intended to be | |||
| surgically placed in the bone of the | |||
| maxillary and/or mandibular arches | |||
| to provide support for prosthetic | |||
| restorations (crowns, bridges or | |||
| overdenture) in edentulous or | |||
| partially edentulous patients to | |||
| restore a patients' chewing function. | Straumann® dental implants are | ||
| indicated for oral endosteal implanta- | |||
| tion in the upper and lower jaw and for | |||
| the functional and esthetic oral rehabil- | |||
| itation of edentulous and partially | |||
| dentate patients. Straumann dental | |||
| implants can also be used for immedi- | |||
| ate or early implantation following | |||
| extraction or loss of natural teeth. | |||
| Implants can be placed with immediate | |||
| function on single-tooth and/or multiple | |||
| tooth applications when good primary | |||
| stability is achieved and with appropri- | |||
| ate occlusal loading, to restore chew- | |||
| ing function. The prosthetic restora- | |||
| tions used are single crowns, bridges | |||
| and partial or full dentures, which are | |||
| connected to the implants by the | |||
| corresponding elements (abutments). | Both implant-systems are indicated | ||
| for placement in the patient's jaw to | |||
| provide support for prosthetic resto- | |||
| rations in edentulous or partially | |||
| edentulous patients | |||
| The wording "maxillary and/or man- | |||
| dibular arches" has the same mean- | |||
| ing as "upper and lower jaw." | |||
| Further minor differences in lan- | |||
| guage do not impact the safety and | |||
| effectiveness of the subject device. | |||
| Bone Trust® implants can also be | |||
| used for immediate loading when | |||
| sufficient primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. | Booth Implant Systems may be used | ||
| for immediate loading when good | |||
| primary stability is achieved. | |||
| Minor differences in language do not | |||
| impact the safety and effectiveness | |||
| of the subject device. | |||
| BoneTrust® Short Dental Implants | |||
| with length 6.5 mm are intended for | |||
| delayed loading only | The inclusion of 6.5mm length spe- | ||
| cific language does not impact the | |||
| safety and effectiveness of the | |||
| subject device. | |||
| BoneTrust® Abutments and | |||
| Prosthetic parts are intended for | |||
| use with Bone Trust Dental | |||
| Implants in the maxillary and/or | |||
| mandibular arches to provide | |||
| support for crowns, bridges or | |||
| overdenture for edentulous or | |||
| partially edentulous patients. | Similar to primary predicate Indica- | ||
| tions for Use | |||
| The wording "maxillary and/or man- | |||
| dibular arches" has the same mean- | |||
| ing as "upper and lower jaw." | |||
| Further minor differences in lan- | |||
| guage do not impact the safety and | |||
| effectiveness of the subject device. | |||
| Further reference devices used for | |||
| technological comparisons of | |||
| BoneTrust® Abutments do not | |||
| include any component-specific | |||
| language that would raise any con- | |||
| cern related to the safety and effec- | |||
| tiveness of the subject devices. | |||
| Further minor differences in lan- | |||
| guage do not impact the safety and | |||
| effectiveness of the subject device |
12
Comparison of Technological Characteristics 6.2.
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:
6.2.1. BoneTrust® plus/cone+ implant
| Company | Candidate:
Medical Instinct
Deutschland GmbH | Primary Predicate:
Straumann AG | Reference Device:
SIC Invent AG | Discussion |
|-------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Name | BoneTrust plus/cone+
implant | Dental Implant System -
Roxolid® SLA Implants | SIC Ace / Max Implants | -- |
| 510(K)
number | -- | K150938 | K173207 | -- |
| Implant
material | Titan Grade 4 ASTM F67 | Titanium Grade 4 | Titanium Grade 4 | Identical |
| Implant
Type | Screw-type | Screw-type | Screw-type | Identical |
| Design | Conical | Conical | Conical | Identical |
| Load | Delayed and Immediate | Delayed and Immediate | Delayed and Immediate | Identical |
| Unit
restora-
tion | Partial or total tooth loss | Partial or total tooth loss | Partial or total tooth loss | Identical |
| Single or
two piece | Two pieces | Two pieces | Two pieces | Identical |
| Screw
type | Self-threading | Self-threading | Self-threading | Identical |
| Distal end | With thread | With thread | With thread | Identical |
| Implant to
abutment
connec-
tion | Cylindrical Internal Hexa-
gon or conical torx | Narrow Neck CrossFit®
(NNC)
Regular Neck (RN)
Wide Neck (WN) | Hex 2.3
Morse Taper | Results of fatigue
testing support that
differences do not
raise any concerns
in regard to safety
and effectiveness of
the implant abutment
interface. |
13
| Company | Candidate:
Medical Instinct
Deutschland GmbH | Primary Predicate:
Straumann AG | Reference Device:
SIC Invent AG | Discussion |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implant
Dimen-
sions
(Diameter
X Length) | Ø3.4 X 8
Ø3.4 X 10
Ø3.4 X 11,5
Ø3.4 X 13
Ø3.4 X14,5
Ø4 X 6.5
Ø4 X 8
Ø4 X 10
Ø4 X 11.5
Ø4 X 13
Ø4 X 14.5
Ø5 X 6.5
Ø5 X 8
Ø5 X 10
Ø5 X 11.5
Ø5 X 13 | Ø3.3 X 8
Ø3.3 X 10
Ø3.3 X 12
Ø3.3 X 14
Ø4.1 X 6
Ø4.1 X 8
Ø4.1 X 10
Ø4.1 X 12
Ø4.1 X 14
Ø4.8 X 6
Ø4.8 X 8
Ø4.8 X 10
Ø4.8 X 12
Ø4.8 X 14 | Ø3.4 / 3.7 X 7.5
Ø3.4 / 3.7 X 9.5
Ø3.4 / 3.7 X 11,5
Ø3.4 / 3.7 X 13
Ø3.4 / 3.7 X14,5
Ø4.0 / 4.2 X 6.0
Ø4.0 / 4.2 X 7.5
Ø4.0 / 4.2 X 9.5
Ø4.0 / 4.2 X 11.5
Ø4.0 / 4.2 X 13.0
Ø4.0 / 4.2 X 14.5
Ø4.5 / 4.7 X 6.0
Ø4.5 / 4.7 X 7.5
Ø4.5 / 4.7 X 9.5
Ø4.5 / 4.7 X 11.5
Ø4.5 / 4.7 X 13.0
Ø4.5 / 4.7 X 14.5
Ø5.0 / 5.2 / 4.7 X 6.0
Ø5.0 / 5.2 / 4.7 X 7.5
Ø5.0 / 5.2 / 4.7 X 9.5
Ø5.0 / 5.2 / 4.7 X 11.5
Ø5.0 / 5.2 / 4.7 X 13
Ø5.0 / 5.2 / 4.7 X 14.5 | Reference device
has been used to
address any dimen-
sions not cleared in
the primary predi-
cate submission. |
| Surface
treatment | blasted-etched | SLA grit blast and
acid etch surface | blasted-etched | Results of non-
clinical testing sup-
port that differences
in surface character-
istics do not raise
any concerns in
regard to safety and
effectiveness of the
proposed devices |
14
6.2.2. Esthetic Abutments
| Company | Candidate: | Reference Device: | Discussion |
|---|---|---|---|
| Medical Instinct Deutschland GmbH | Altatech GmbH | ||
| Device Name | BoneTrust® Esthetic Abutments | CAMLOG Abutments | -- |
| 510(K) num- | |||
| ber | -- | K083496 | -- |
| Material | Titanium alloy TiAl4V | Titanium alloy TiAl4V | Identical |
| Surface | Anodized surface | Anodized surface | Identical |
| Size | Ø3.4: | ||
| 0°: GH 0.5, 2.5, 4.5mm | |||
| 15°: GH 0.5, 2.5mm | |||
| 20°: GH 0.7mm | |||
| Ø4.0: | |||
| 0°: GH 0.5, 2.5, 4.5mm | |||
| 15°: GH 0.5, 2.5mm | |||
| Ø5.0: | |||
| 0°: GH 2.5mm | |||
| 15°: GH 0.5mm, 2.5mm | |||
| Total Abutment height: 10.1 mm, 11.6 mm | Platform Diameter: ø 3.3 - 3.8 - 4.3 - 5.0 - | ||
| 6.0 mm | |||
| Body Diameter: 4.5 to 8.0 mm | |||
| Gingival Height: 0.8 - 1.0 - 1.8 - 2.5 - 3.0 - | |||
| 4.5 mm | |||
| Total Abutment height: 8.7 mm - 11.7 mm | Substantially equiva- | ||
| lent | |||
| Sizes are within | |||
| range of the Refer- | |||
| ence Device, except | |||
| Gingival Height (GH) | |||
| of 0.5 / 0.7mm. This | |||
| difference does not | |||
| raise any concerns | |||
| in regard to safety | |||
| and effectiveness of | |||
| the proposed devic- | |||
| es | |||
| Connection | Cylindrical external Hexagon or and | ||
| conical torx | Conical fitting | Results of dynamic | |
| fatigue testing sup- | |||
| port that differences | |||
| in inner geometry do | |||
| not raise any con- | |||
| cerns in regard to | |||
| safety and effective- | |||
| ness of the implant | |||
| abutment interface. | |||
| Angulation | 0° - 15° - 20° | 0° - 15° - 20° | Identical |
6.2.3. Wide Body Abutments
| Company | Candidate: | Reference Device: | Discussion |
|---|---|---|---|
| Medical Instinct Deutschland GmbH | Altatech GmbH | ||
| Device Name | BoneTrust® Wide Body Abutments | CAMLOG Abutments | -- |
| 510(K) num- | |||
| ber | -- | K083496 | -- |
| Material | Titanium alloy TiAl4V | Titanium alloy TiAl4V | Identical |
| Surface | Anodized surface | Anodized surface | Identical |
| Size | Platform Diameter: ø 3.4 - 4.0 - 5.0 mm | ||
| Body Diameter: 7.4 / 7.6 mm | |||
| Gingival Height: 3.0 mm | |||
| Total Abutment height: 11.2 mm, 11.6 mm | Platform Diameter: ø 3.3 - 3.8 - 4.3 - 5.0 - | ||
| 6.0 mm | |||
| Body Diameter: 4.5 to 8.0 mm | |||
| Gingival Height: 0.8 - 1.0 - 1.8 - 2.5 - 3.0 - | |||
| 4.5 mm | |||
| Total Abutment height: 8.7 mm - 11.7 mm | Sizes are within | ||
| range of Reference | |||
| Device, |
15
| Connection | Cylindrical external Hexagon or and coni-
cal torx | Conical fitting | Results of dynamic
fatigue testing sup-
port that differences
in inner geometry do
not raise any con-
cerns in regard to
safety and effective-
ness of the implant
abutment interface |
|------------|-------------------------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Angulation | $0^{\circ}$ | $0^{\circ}$ - 15° - 20° | within range of
Reference device |
6.2.4. UCLA Abutments
| Company | Candidate:
Medical Instinct Deutsch-
land GmbH | Reference Device:
Institut Straumann AG | Reference Device
Biomet 3i | Discussion |
|---------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Name | BoneTrust® Abutments | RN synOcta UCLA Gold
Abutment | UCLA Gold / castable
Abutment | -- |
| 510(K)
number | -- | K041295 | K072642 | -- |
| Material | Heraplat Au 61%, Pt 23,8%,
Pd, 15% Rh 0,2% /
Platinum-Iridium-alloy
(Ptlr20%) | Ceramicor®
Au 60%, Pd 20%, Pt 19%,
Ir 1% | Machined Gold Alloy | Materials conform to ISO
22674 standard. Bio-
compatibility Assess-
ment and testing support
substantial equivalence
to reference device |
| Material
Burn out-
sleeve | POM | POM | Plastic | Identical to K041295 |
| Size | Diameter ø 3.4, 4.0, 5.0 mm
Cylinder height: 3 mm | Diameter: 4.8, 6.5
Cylinder height: 1.8 - 3.35
mm | Diameter
ø 3.4, 4.1, 5.0, 6.0 mm
Cylinder height: 4 mm | Diameters are within the
range of K072642, Cyl-
inder Heights and total
heights are similar to
K041295 |
| Surface | Anodized | Anodized | Anodized | Identical |
| Connection | Cylindrical external Hexagon
or conical torx | SynOcta connection
Cone -octagon | Hexed and non-hexed
connection | Results of dynamic
fatigue testing support
that differences in inner
geometry do not raise
any concerns in regard
to safety and effective-
ness of the implant
abutment interface |
6.2.5. Direct Abutment
| Company | Candidate: | Reference Device: | Discussion |
|---|---|---|---|
| Medical Instinct Deutschland GmbH | Nobel Biocare AB | ||
| Device Name | BoneTrust® Abutments | NobelActive Multi Unit Abutment – Gold | |
| Coping Multi-Unit Abutment | -- | ||
| 510(K) num- | |||
| ber | -- | K072570 | -- |
| Material | Titanium alloy TiAl4V | CP titanium (Grade 4) | |
| Titanium alloy TiAl4V | Identical |
16
| Surface | Anodized surface | machined | Results of biocompati-
bility assessment and
testing support that
differences in surface
treatment do not raise
any concerns in regard
to safety and effective-
ness of the proposed
device |
|------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Size | Diameter Ø 3.4, 4.0, 5.0 mm
Gingival Height: 1, 2, 3 mm
Total height: 9.1, 9.4 mm | Diameter Ø 3.5, 4.3, 5.0 mm
Gingival Height: 1, 2, 3, 4, 5 mm
Total height: not known | Platform Sizes are
adapted to platform
diameter of the implant
system. Minor differ-
ences do not raise any
concerns in regard to
safety and effectiveness
of the proposed device |
| Connection | Cylindrical external Hexagon or and coni-
cal torx | External Hex, Conical | Results of dynamic
fatigue testing support
that differences in inner
geometry do not raise
any concerns in regard
to safety and effective-
ness of the implant
abutment interface |
| Angulation | 0°, 20°, 30° | 0°, 17°, 30° | Within range of Refer-
ence Device |
6.2.6. Auro Base Abutment
| Company | Candidate: | Reference Device: | Discussion |
|---|---|---|---|
| Company | Medical Instinct Deutschland GmbH | Nobel Biocare AB | |
| Device Name | BoneTrust® Abutments | NobelActive Multi Unit Abutment - Gold | |
| Coping Multi-Unit Abutment | -- | ||
| 510(K) num- | |||
| ber | -- | K072570 | -- |
| Material | Heraplat Au 61%, Pt 23,8%, Pd, 15% Rh | ||
| 0,2% / | |||
| Platinum-Iridium-alloy (PtIr20%) | Au 60%, Pd 20%, Pt 19%, Ir 1% | Materials conform to | |
| ISO 22674 standard. | |||
| Biocompatibility As- | |||
| sessment and testing | |||
| support substantial | |||
| equivalence to refer- | |||
| ence device | |||
| Material Burn | |||
| out sleeve | POM | Burn out plastic | Substantially equivalent |
| Surface | Machined | machined | Identical |
| Size | Cylinder Height [mm]: 3.2 | ||
| Platform Diameter [mm]: 3.4 / 4.0 | |||
| Body Diameter [mm]: 3.1 | Cylinder Height [mm]: 3.0 | ||
| Platform Diameter [mm]: Ø 3.5, 4.3, 5.0 | |||
| mm | |||
| Body Diameter [mm]: not known | Results of dynamic | ||
| fatigue testing support | |||
| that differences in | |||
| Abutment size do not | |||
| raise any concerns in | |||
| regard to safety and | |||
| effectiveness of the | |||
| proposed device |
17
| Connection | Cylindrical external Hexagon or and coni-
cal torx | External Hex, Conical | Results of dynamic
fatigue testing support
that differences in inner
geometry do not raise
any concerns in regard
to safety and effective-
ness of the implant
abutment interface |
|------------|-------------------------------------------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Angulation | 0° | 0° | Identical |
6.2.7. Telescopic Abutment
| Company | Candidate:
Medical Instinct Deutsch-
land GmbH | Reference Device:
Altatech GmbH | Reference Device
Dentsply Implants GmbH | Discussion |
|------------------|------------------------------------------------------|-----------------------------------------|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Name | BoneTrust® Telescopic
Abutments | CONELOG Telescopic
Abutments | Friadent Telescopic Abut-
ment | -- |
| 510(K)
number | -- | K113779 | K021318 | -- |
| Material | Titanium alloy TiAl4V | Titanium alloy TiAl4V | Titanium alloy TiAl4V | Identical |
| Surface | Machined surface | Machined surface | Machined surface | Identical |
| Connection | Cylindrical external Hexa-
gon or conical torx | Conical fitting | Hexagon connection | Results of dynamic
fatigue testing support
that differences in
inner geometry do not
raise any concerns in
regard to safety and
effectiveness of the
implant abutment
interface |
| Size | Diameter: 3,4 / 4 mm | Diameters: 3.8, 4.3, 5.0,
and 6.0 mm | Diameters: 3.4, 3.8, 4.5, 5.5
mm | Within range of
K021318 |
| Maximum
Taper | 5° | 5° | Not known | identical to K113779 |
6.2.8. Healing Abutment
| Company | Candidate:
Medical Instinct Deutschland
GmbH | Reference Device:
SIC Invent AG | Discussion |
|--------------------------|----------------------------------------------------|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Name | BoneTrust® Healing Abutments | SIC Gingiva Shaper | -- |
| 510(K)
number | -- | K173207 | -- |
| Maximum
intraoral use | 180 Days | 180 Days | Identical |
| Load | Non-occlusal loading | Non-occlusal loading | Identical |
| Material | Titanium alloy TiAl4V | Titanium alloy TiAl4V | Identical |
| Surface | anodized surface | anodized surface | Identical |
| Connection | Cylindrical external Hexagon or
conical torx | Conical or cylindrical fitting | Results of dynamic fatigue test-
ing support that differences in
inner geometry do not raise any
concerns in regard to safety and
effectiveness of the implant -
abutment interface |
18
| Size | Platform
Diameter | Gingival Height
(GH) | Platform
Diameter | Gingival Height (GH) | Reference device does not
include a device with platform
diameter equal to or smaller than
3.4 mm with a gingival height of
7.0 mm.
The inclusion of a Ø3.4x7.0 mm
Healing Abutment does not
impact safety and effectiveness
as healing abutments are placed
out of occlusion. The gingival
height is only to shape the gingi-
va, not withstand load |
|------|----------------------|-----------------------------------|-----------------------|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 3.4 mm | 1.5 mm, 3.0 mm,
5.0 mm, 7.0 mm | 3.0 mm | 1.0 mm, 2.0 mm, 3.0
mm, 4.0 mm, 5.0 mm, | |
| | 4.0 mm | 1.5 mm, 3.0 mm,
5.0 mm | 3.7 mm | 1.0 mm, 1.5 mm, 2.0
mm, 3.0 mm, 4.0 mm,
5.0 mm, 7.0 mm | |
| | 5.0 mm | 1.5 mm, 3.0 mm,
5.0 mm | 4.2 / 4.7 / 5.2
mm | 1.0 mm, 1.5 mm, 2.0
mm, 3.0 mm, 4.0 mm,
5.0 mm, 7.0 mm | |
6.2.9. Direct Healing Abutment
| Candidate: | Reference Device: | ||
|---|---|---|---|
| Company | Medical Instinct Deutschland GmbH | Nobel Biocare USA LLC | Discussion |
| Device | |||
| Name | BoneTrust® Direct Healing Abutments | Healing Cap Multi-Unit Titanium | -- |
| 510(K) | |||
| number | -- | K171142 | -- |
| Maximum | |||
| intraoral use | 180 Days | 180 Days | Identical |
| Load | Non-occlusal loading | Non-occlusal loading | Identical |
| Material | Titanium alloy TiAl4V | Titanium alloy Ti6Al4V ELI | |
| (ASTM F136) | Identical | ||
| Surface | anodized surface | anodized surface | Identical |
| Connection | Cylindrical external Hexagon or and conical | ||
| torx | Conical fitting | Results of dynamic | |
| fatigue testing support | |||
| that differences in | |||
| inner geometry do not | |||
| raise any concerns in | |||
| regard to safety and | |||
| effectiveness of the | |||
| implant - abutment | |||
| interface | |||
| Size | Healing Cap Height: 4.75 mm | ||
| Healing Cap Diameter 4.9 mm | Healing Cap Height: 4.1 and 5.5 mm | ||
| Healing Cap Diameter 5.0, 6.0, 6.9 mm | Sizes are within range | ||
| of K171142, except | |||
| Healing Cap Diameter | |||
| is 0.1 mm smaller. | |||
| This difference is due | |||
| to the specific fitting to | |||
| the abutment and | |||
| does not raise any | |||
| concerns in regard to | |||
| safety and effective- | |||
| ness of the proposed | |||
| devices | |||
| Compatible | |||
| Abutments | Bone Trust® Direct Abutments | Nobel Biocare Multi Unit Abutments | Adapted to fit manu- |
| facturer's abutment | |||
| system |
19
m
| Company | Candidate: | Reference Device: | Discussion | |
|---|---|---|---|---|
| Medical Instinct Deutschland GmbH | Straumann USA | |||
| Device | ||||
| Name | BoneTrust® Healing Abutments Wide Body | Healing Abutment | -- | |
| 510(K) | ||||
| number | -- | K130808 | -- | |
| Maximum | ||||
| intraoral use | 180 Days | 180 Days | Identical | |
| Load | Non-occlusal loading | Non-occlusal loading | Identical | |
| Material | Titanium alloy TiAl4V | Titanium alloy Ti6Al4V ELI | ||
| (ASTM F136) | Identical | |||
| Surface | anodized surface | anodized surface | Identical | |
| Connection | Cylindrical external Hexagon or and conical | |||
| torx | Conical fitting | Results of dynamic | ||
| fatigue testing support | ||||
| that differences in | ||||
| inner geometry do not | ||||
| raise any concerns in | ||||
| regard to safety and | ||||
| effectiveness of the | ||||
| implant - abutment | ||||
| interface | ||||
| Size | Platform Diameter | Gingival Height | ||
| (GH) | Plattform Diameters: 3.3mm, 3.5mm, | |||
| 4.1mm, 4.8mm, 6.5mm | ||||
| Gingival Heights: | ||||
| 2.0mm, 3.5mm, 4.0mm, 5.0mm, 6.0 mm | Within range of refer- | |||
| ence device | ||||
| 3.4 mm / 4.0 mm | 3.0 mm, 5.0 mm | |||
| 5.0 mm | 3.0 mm, 5.0 mm |
6.2.10. Healing Abutment Wide Body
7. Performance testing
7.1. Summary of Clinical Testing
No clinical studies were performed for the BoneTrust® 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
Biocompatibility assessment has been performed according to ISO 10993 series and included testing for cytotoxicity according to ISO 10993-5.
Results support substantial equivalence of the BoneTrust® implants to legally marketed predicate devices.
20
7.2.2. Fatigue testing
Fatigue testing of the implant-abutment interface has been tested for representative samples in accordance with ISO 14801.
Results support substantial equivalence of the BoneTrust® implants to legally marketed predicate devices.
7.2.3. Sterilization
Validation of sterilization instructions for non-sterile devices have been conducted according to ISO 17665-1 and ISO 17665-2 for pre-vacuum steam sterilization (wrapped cycle) demonstrating a sterility assurance level (SAL) of 10-6.
Sterilization validation for device delivered sterile has been conducted according to ISO 11137-1 and 11137-2 for Beta-radiation sterilization. Shelf life testing has been conducted according to ISO 11607-1 and ASTM F1980 under consideration of accelerated and real-time ageing conditions. LAL testing was conducted according to USP 85 and the FDA Guidance "Submission and Review of Sterility information in Premarket Notification 510k Submissions for Devices Labeled as Sterile."
7.2.4. Implant Surface Analysis
Investigation of the implant surface included Energy Dispersive X-ray Spectroscopy (EDX), SEM (Scanning Electron Microscopy) and BSE (Back-Scattered-Electrons / secondary electrons analysis. Results support substantial equivalence of the BoneTrust® implants to legally marketed predicate devices.
Non-clinical Performance Data BoneTrust® Short Implants 7.2.5.
In order to verify substantial equivalence to already marketed devices. BoneTrust® short implants were subjected to the following non-clinical performance studies:
- . Comparative Surface area analysis
- . Comparative Bone-to-implant contact study using animal histology
- . Comparative pull-out strength test
Results support substantial equivalence of the BoneTrust® short implants to legally marketed predicate devices.
Conclusion as to Substantial Equivalence 8.
Based on the comparison of the indications for use, the technological characteristics and the nonclinical testing it can be concluded that the BoneTrust® Implant System is substantially equivalent to the predicate devices.