(494 days)
No
The summary describes a standard dental implant system with no mention of AI or ML capabilities.
Yes.
The device is intended to restore chewing function and provide support for prosthetic restorations, which involves treating a medical condition (edentulism or partial edentulism).
No
The device description indicates that Nucleoss Tpure Implant System are medical devices intended to be surgically placed in the bone to provide support for prosthetic restorations. This functionality is therapeutic, not diagnostic.
No
The device description clearly outlines physical components made of titanium, including implants, abutments, covers, and other accessories, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is surgically placed in bone to support prosthetic restorations and restore chewing function. This is a direct therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical components of a dental implant system (implants, abutments, covers, etc.) made of materials like titanium. This aligns with a surgical implant, not a diagnostic reagent or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on biocompatibility, fatigue testing, MRI safety, and sterilization validation, which are relevant to the safety and efficacy of a surgical implant, not a diagnostic device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Nucleoss Tpure Implant System 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.
Nucleoss Tpure Dental Implants are intended for delayed loading after 12 weeks.
Nucleoss Abutments and Prosthetic parts are intended for use with Nucleoss Tpure Dental Implants in the maxillary and/ or mandibular arches to provide support for crowns, bridges or overdenture for edentulous patients.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Nucleoss Tpure Implant System consists of the Nucleoss Tpure Dental Implant, Nucleoss Dental Abutments, Covers, Gingiva Formers, Comfort Caps, and accessories.
The Nucleoss Tpure Implant is a bone level, root form implant constructed of unalloyed titanium per ISO 5832-2, with an SLA surface treatment. Nucleoss Tpure Implants have a conical form design, with a double lead thread form and two vertical anti-rotation grooves. The internal structure is designed as a conical internal hex connection with 80 degree bevel.
Nucleoss Tpure Implants are provided in the following sizes: 3.4 mm diameter with lengths of 10, 12 and 14 mm, and 3.8, 4.2, 5.0 mm diameters with lengths of 8, 10, 12, and 14 mm.
Nucleoss Dental Abutments are constructed of titanium alloy per ISO 5832-3and are intended for cement-retained and screw-retained restorations. An internal hexagon allows connection to the Nucleoss Tpure implant. Nucleoss Dental Abutments are available in Straight, Angled, Multi-unit, Ball and Equator designs. The Angled abutment is provided in angles of 10, 20 and 30 degrees. The Multi-unit abutment is available in a straight design, and angled designs of 17 and 30 degrees. Nucleoss Covers, Comfort Cap and Gingiva Formers are available for use during the healing period following surgical placement of the implant. The Nucleoss Tpure Implant System also includes metal housings combined with caps to provide a secure coupling for the denture prosthetic attachment to the Ball and Equator abutments.
All of the Nucleoss Tpure Implant System components are single-use devices. The Nucleoss Tpure Implant and related Cover is provided sterile. The Nucleoss Abutments and accessories are provided nonsterile for end-user sterilization.
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
Not Found
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 of the Nucleoss Tpure Implant System was performed following the FDA guidance: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments, and applicable ISO and ASTM standards.
Biocompatibility: Cytotoxicity, Manufacturing Process FMEA Risk Analysis, SEM & Energy Dispersive X-ray Spectroscopy (EDX) Implant Surface Study, Chemical Analysis of Implant Surface. The test results and analyses found that the dental implant material and manufacturing processes were biocompatible.
Fatigue Testing: conducted in accordance with ISO 14801:2007 Dentistry- Implants-Dynamic Fatigue Test for Endosseous Dental Implants found the durability of the Nucleoss Tpure Implant and Abutment combinations was acceptable. Testing was conducted on the worst case implant abutment combinations.
MRI Safety: Nucleoss Dental Implant Systems were found to be MR Conditional following testing in accordance with ASTM: F 2052-14 Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment, ASTM F2182-11a Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging, and ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.
Sterilization Validation: Nucleoss Tpure Implants are sterilized using a gamma ray sterilization process that has been validated in accordance with ISO 11137-2 Sterilization of healthcare products-Radiation-Part 2 establishing the sterilization dose to ensure a SAL of 10 °. 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." Shelf life testing was conducted according to ASTM D4169-16, ASTM F1980-16, ASTM F1929-15, ASTM D5276-98, and ASTM F88/F88M-15. Nucleoss Dental Abutments are provided non-sterile for end-user steam sterilization using a traditional cycle process as identified in the FDA Guidance for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. The recommended end user steam sterilization parameters were validated in accordance with ISO 17665-1:2006 and ISO 17665-2 2009.
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.
K151194, K122988, K141544, K161677
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2017
Sanlılar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Limited Sirketi % H. Semih Oktay, PhD President CardioMed Device Consultants, LLC 1783 Forest Drive, #254 Annapolis, Maryland 21401
Re: K160850
Trade/Device Name: Nucleoss Tpure Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 4, 2017 Received: July 6, 2017
Dear H. Semih Oktay:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Andrew I. Steen -S
- for Lori A. Wiggins, MPT, CLT 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) K160850
Device Name Nucleoss Tpure Implant System
Indications for Use (Describe)
Nucleoss Tpure Implant System 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.
Nucleoss Tpure Dental Implants are intended for delayed loading after 12 weeks.
Nucleoss Abutments and Prosthetic parts are intended for use with Nucleoss Tpure Dental Implants in the maxillary and/ or mandibular arches to provide support for crowns, bridges or overdenture for edentulous patients.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY (21 CFR 807.92)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92
Premarket Notification 510(k) Summary
I. SUBMITTER
| Submitter's Name: | Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Limited Sirketi |
|---|---|
| Address: | 10018 Sok. No 7 ITOB Organize Sanayi Bolgesi Tekeli, Izmir |
| TR-35477 | |
| Turkey | |
| Telephone: | 90-232-799 0304 |
| Fax Number: | 90-232-799 0306 |
| Contact Person: | Ezgi OZBUDAK |
| US Consultant: | CardioMed Device Consultants |
| Address: | 1783 Forest Drive, #254 |
| Annapolis, MD 21401 | |
| Telephone: | 410- 674-2060 |
| Email: | soktay@cardiomedllc.com |
| Contact Person: | H. Semih Oktay. President |
Date of Summary: August 4, 2017
II. DEVICE
| Trade Name: | Nucleoss Tpure Implant System |
|---|---|
| Common Name: | Endosseous Dental Implant & Abutments |
| Product Codes: | DZE (Primary Product Code), NHA |
| Regulatory Class: | II |
| Classification name: | 21 CFR 872.3640 Endosseous Dental implan |
III. PREDICATE DEVICE
Primary Predicate device: Straumann Bone Level Tapered Implants - K140878
Reference Predicate devices:
Klockner Dental Implant Abutments (II) - K151194 Klockner Dental Implant Abutments - K122988 Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System - K141544 Straumann Sterile Healing Solution - K161677
4
IV. DEVICE DESCRIPTION
The Nucleoss Tpure Implant System consists of the Nucleoss Tpure Dental Implant, Nucleoss Dental Abutments, Covers, Gingiva Formers, Comfort Caps, and accessories.
The Nucleoss Tpure Implant is a bone level, root form implant constructed of unalloyed titanium per ISO 5832-2, with an SLA surface treatment. Nucleoss Tpure Implants have a conical form design, with a double lead thread form and two vertical anti-rotation grooves. The internal structure is designed as a conical internal hex connection with 80 degree bevel.
Nucleoss Tpure Implants are provided in the following sizes: 3.4 mm diameter with lengths of 10, 12 and 14 mm, and 3.8, 4.2, 5.0 mm diameters with lengths of 8, 10, 12, and 14 mm.
Nucleoss Dental Abutments are constructed of titanium alloy per ISO 5832-3and are intended for cement-retained and screw-retained restorations. An internal hexagon allows connection to the Nucleoss Tpure implant. Nucleoss Dental Abutments are available in Straight, Angled, Multi-unit, Ball and Equator designs. The Angled abutment is provided in angles of 10, 20 and 30 degrees. The Multi-unit abutment is available in a straight design, and angled designs of 17 and 30 degrees. Nucleoss Covers, Comfort Cap and Gingiva Formers are available for use during the healing period following surgical placement of the implant. The Nucleoss Tpure Implant System also includes metal housings combined with caps to provide a secure coupling for the denture prosthetic attachment to the Ball and Equator abutments.
All of the Nucleoss Tpure Implant System components are single-use devices. The Nucleoss Tpure Implant and related Cover is provided sterile. The Nucleoss Abutments and accessories are provided nonsterile for end-user sterilization.
V. INDICATIONS FOR USE
Nucleoss Tpure Implant System 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.
Nucleoss Tpure Dental Implants are intended for delayed loading after 12 weeks.
Nucleoss Abutments and Prosthetic parts are intended for use with Nucleoss Tpure Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdenture for edentulous or partially edentulous patients.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological characteristics of the Nucleoss Tpure Implant System was compared to the predicate devices to determine substantial equivalence. The Nucleoss Toure Dental Implant, Nucleoss Dental Abutments, Cover, Gingiva Former and Comfort Cap, have a similiar indication for use, material composition, surface treatment and design as the predicate devices.
The Nucleoss Tpure Dental Implant indication for use differs from the predicate Straumann Bone Level Tapered Implants (K140878) in that the Nucleoss Tpure Dental Implant is intended for delayed loading only, and is not restricted to four implants in edentulous patients. These differences do not raise new concerns because limiting the use of the dental implant to delayed loading is a more conservative surgical approach, and the use of fewer implants for a tissue-supported overdenture is a standard clinical protocol.
Similarly, differences in the Indication for Use of the Nucleoss Abutment System and the predicates [Klockner Dental Implant Abutments (K151194 and K122988), and Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System (K141544)] do not affect substantial equivalence because each of the abutments are intended for use with specific dental implants for the purpose of providing support for prosthetic reconstructions.
The Nucleoss Tpure Dental Implant with a maximum implant diameter of 5.0mm differs from the predicate, Straumann Bone Level Tapered Implants (K140878) maximum implant diameter of 4.8 mm. This difference is compatible with the variation in anatomical sizes of the human jaw bone, and does not present a worst-case scenario for the device.
The Nucleoss Straight and Angled Abutment designs are for single or multiple cement retained restorations, whereas the predicate Klockner Dental Implant Abutments (K151194 and K122988) are only for multiple screw retained restorations.
The Nucleoss Multi-unit Abutment differs from the Klockner Dental Implant Abutments (K151194 and K122988) abutments for multiple and single restorations with respect to connection type. The Nucleoss Multi-unit Abutments have internal hex connection, while the Klockner abutmnts have internal cone connection. Performance testing of the Nucleoss Dental Implant combined with the Nucleoss Multi-unit Abutment demonstrated substantial equivalence of the connection platform design.
The Nucleoss Abutment platform diameter range (4.2mm – 6.0mm) differs from that of the predicate Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System (K141544) which has platform diameters of 3.4 mm to 6.0mm.
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The Nucleoss Tpure Implant System also offers an additional overdenture abutment design, the Equator Abutment. The Equator Abutment provides a different connection design for the denture but does not change the intended use of supporting a denture restoration.
The Gingiva Former and Cover differs from the predicate, Straumann Sterile Healing Solution (K161677) with respect to additional platform diameter sizes. The additional platform sizes are provided so as to accomodate the Nucleoss Dental Implant.
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Substantial Equivalence Comparison – Nucleoss Tpure Dental Implant
| Technological
Characteristics | SUBJECT DEVICE | PRIMARY PREDICATE
DEVICE |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Nucleoss Tpure Dental Implant | Straumann Bone Level Tapered Implants
(K140878) |
| Indications for Use | Indicated for surgical placement 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.
Nucleoss Tpure Dental Implants are intended for delayed
loading after 12 weeks.
Nucleoss Abutments and Prosthetic parts are intended for
use with Nucleoss Tpure Dental Implants in the maxillary
and/or mandibular arches to provide support for crowns,
bridges or overdenture for edentulous or partially
edentulous patients | Indicated for oral endosteal implantation in the upper and
lower jaw and for the functional and esthetic oral
rehabilitation of edentulous and partially dentate patients.
Straumann dental implants can also be used for immediate 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 appropriate occlusal
loading, to restore chewing function. The prosthetic
restorations used are single crowns, bridges and partial or
full dentures, which are connected to the implants by the
corresponding elements (abutments). In cases of fully
edentulous patients, 4 or more implants must be used in
immediately loaded cases. |
| Material | Grade 4 commercially pure titanium conforming with
ISO 5832-2 | Grade 4 commercially pure titanium conforming with ISO
5832- 2 |
| Surface Treatment | Sand blasted Large grit Acid etched (SLA) | Sand blasted Large grit Acid etched (SLA) |
| Design | Two component / Bone level/Conical form
Two stage surgical technique
For single or multiple restorations
Tpure Implant threads are designed in double lead thread
form with two vertical anti-rotation grooves.
Constant major and minor thread diameters (i.e., parallel
wall) 0.75mm thread pitch.
Angled major and minor thread diameters (i.e., tapered
wall), with the major and minor diameters have differing
angles such that the depth increases toward the apical end
of the implant and the addition of cutting flutes 0.75mm
thread pitch. | Two component / Bone level/Conical form
Two stage surgical technique
For single or multiple restorations
Constant major and minor thread diameters (i.e., parallel
wall) 0.8mm thread pitch.
Angled major and minor thread diameters (i.e., tapered
wall), with the major and minor diameters have differing
angles such that the depth increases toward the apical end of the implant and the addition of cutting flutes 0.8mm thread pitch. |
| | | |
| | The internal structure is designed as a conical internal
hex connection with 80 degrees. | |
| Transfer piece | Fixture-mount transfer part, intended to support the
implant while in the primary package, to aid in the
removal of the implant from the primary package, and to
aid in placement of the implant into the osteotomy site. | Snap fit mount LoximTM transfer piece, intended to support
the implant while in the primary package, to aid in the
removal of the implant from the primary package, and to aid
in placement of the implant into the osteotomy site. |
| Diameter (mm) | 3.4, 3.8, 4.2, 5.0 | 3.3, 4.1, 4.8 |
| Length (mm) | 8, 10, 12, 14 | 8, 10, 12, 14 |
| Sterilization | Sterile (Gamma irradiation) | Sterile (Gamma irradiation) |
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Substantial Equivalence Comparison - Nucleoss Dental Abutments
| | SUBJECT DEVICE | REFERENCE PREDICATE
DEVICE | REFERENCE PREDICATE
DEVICE | REFERENCE PREDICATE
DEVICE |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| | Nucleoss Abutment System | Klockner Dental Implant
Abutments (II)
(K151194) | Klockner Dental Implant
Abutments
(K122988) | Zimmer Zfx Titanium
Abutment for Biomet 3i
Certain Implant System
(K141544) |
| Material | Titanium alloy | Titanium alloy
Gold alloy & Co-Cr-Mo alloy
(for Cast abutment) | Titanium Alloy | Titanium alloy |
| Abutment
Design | Straight and Angled (10-30°):
For single or multiple cement
retained restorations
Internal hex connection.
Multi-unit: For multiple screw-
retained restorations
Internal hex connection
Equator and Ball:
For overdenture restorations
Internal hex connection | Straight and Angled (10-30°):
For multiple-unit screw-
retained restorations
Internal octagonal cone
connection
Cast: For single or multiple-
unit cement-retained
restorations
Temporary: For multiple-unit
screw-retained restorations | Straight and Angled (10-30°):
For multiple-unit screw-
retained restorations
Internal octagonal & external
hexagonal connection system
Temporary: For multiple-unit
screw-retained restorations
Overdenture:Screw-retained
Ball attachment design | Patient-Specific: abutment
For single or multiple screw-
retained restorations
Angled Abutments (10-30°)
Internal hex connection |
| Abutment
Platform
Diameter (mm) | Straight & Angled: 4.2, 5.0, 6.0
Ball: 4.5
Multi-unit: 5.0 mm | Not known | Standard and wide platform | 3.4, 4.1, 5.0 and 6.0 |
| Abutment | Straight: 1.0, 2.0, 3.0, 5.0 | Straight: | Not known | Not known |
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| Platform
Heights
(mm) | Angled: 1.0, 2.0, 3.0, 4.0
Multi-unit: 0°: 1.5, 3.0, 5.0
17°:1.5-3.1 & 2.4-4.0
30°:1.25-4.0 & 2.0 - 4.75
Ball & Equator: 1.5, 3.0, 5.0 | 1.0, 2.5 & 4.0
Angled:
2.0, 3.0, 4.0 & 5.0 | | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-----------|----------------------|
| Sterilization | Provided non-sterile | Provided non-sterile | Not known | Provided non-sterile |
Substantial Equivalence Comparison – Nucleoss Gingiva Former and Cover
| Technological
| Characteristics | SUBJECT DEVICE | REFERENCE PREDICATE DEVICE |
|---|---|---|
| Nucleoss Gingiva Former and Cover | Straumann Sterile Healing Solution (K161677) | |
| Material | Titanium alloy per ISO 5832-3 | Pure Titanium (grade 4) per ISO 5832-2 |
| Design | The Cover and Gingiva Former are screwed | |
| on the implant to cover the implant. | ||
| Gingiva Former and Cover are color coded | ||
| according to their platform diameter. | The devices are available in one and two-piece assemblies, and in | |
| various diameters and heights. | ||
| Healing abutment, closure cap and closure screw are color coded; | ||
| yellow and purple. | ||
| Platform | ||
| Diameter (mm) | Gingiva Former: 4.2, 5.0, 6.0 | |
| Cover: 4.2, 5.0, 6.0 | ||
| Platform | ||
| Heights (mm) | Gingiva Former: 2.0, 4.0, 6.0 | |
| Cover: 0 | Healing abutment: 2.0, 4.0, 6.0 | |
| Closure cap: 0, 1.5, Closure screw: 0, 0.5 | ||
| Sterilization | Cover: Gamma irradiation (with implant). | |
| Gingiva Former: provided non-sterile. | Provided sterile via Gamma Irradiation |
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VII. PERFORMANCE DATA
Non-clinical testing of the Nucleoss Tpure Implant System was performed following the FDA guidance: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments, and applicable ISO and ASTM standards.
Biocompatibility
Cytotoxicity Manufacturing Process FMEA Risk Analysis SEM & Energy Dispersive X-ray Spectroscopy (EDX) Implant Surface Study Chemical Analysis of Implant Surface
The test results and analyses found that the dental implant material and manufacturing processes were biocompatible.
Fatigue Testing
Fatigue testing, conducted in accordance with ISO 14801:2007 Dentistry- Implants-Dynamic Fatigue Test for Endosseous Dental Implants found the durability of the Nucleoss Tpure Implant and Abutment combinations was acceptable. Testing was conducted on the worst case implant abutment combinations.
MRI Safety
Nucleoss Dental Implant Systems were found to be MR Conditional following testing in accordance with ASTM: F 2052-14 Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment, ASTM F2182-11a Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging, and ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.
Sterilization Validation
Nucleoss Tpure Implants are sterilized using a gamma ray sterilization process that has been validated in accordance with ISO 11137-2 Sterilization of healthcare products-Radiation-Part 2 establishing the sterilization dose to ensure a SAL of 10 °. 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." Shelf life testing was conducted according to ASTM D4169-16, ASTM F1980-16, ASTM F1929-15, ASTM D5276-98, and ASTM F88/F88M-15.
Nucleoss Dental Abutments are provided non-sterile for end-user steam sterilization using a traditional cycle process as identified in the FDA Guidance for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. The recommended end user steam sterilization parameters were validated in accordance with ISO 17665-1:2006 and ISO 17665-2 2009.
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VIII. CONCLUSION
The Nucleoss Tpure Dental Implant System have the same or similar intended use, material composition, design, and surface treatment. Based on an a comparative assessment with the predicate devices, and the performance test data, the Nucleoss Tpure Dental Implant System is determined to be substantially equivalent to the predicate devices.