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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for the Nucleoss Tpure Implant System. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria in a clinical study with a detailed and quantified performance table as might be found for novel AI/ML devices or pharmaceutical trials.

Therefore, the information typically requested in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, how ground truth was established for the training set) is generally not applicable to this type of medical device submission (dental implants). These are mechanical and material-based devices, not AI/ML-driven diagnostic or prognostic tools.

Instead, substantial equivalence for the Nucleoss Tpure Implant System is demonstrated through:

Comparison of Technological Characteristics: Showing that the device has similar indications for use, material composition, surface treatment, and design to predicate devices.
Non-clinical Performance Data: Testing to confirm the device's physical and biological properties meet safety and performance standards.

Here's the information extracted from the document, presented in a modified format relevant to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this device (Nucleoss Tpure Implant System), "acceptance criteria" and "reported device performance" are primarily demonstrated through comparisons to predicate devices and non-clinical performance testing to established standards, rather than clinical performance metrics like sensitivity/specificity for a diagnostic AI.

Characteristic / Test	Acceptance Criteria (Demonstrated by)	Reported Device Performance
Indications for Use	Substantially equivalent to predicate devices, with differences not raising new concerns (e.g., delayed loading only for the subject device is a more conservative approach).	Nucleoss Tpure Implant System: Intended for surgical placement in maxillary/mandibular arches to support prosthetic restorations (crowns, bridges, overdenture) in edentulous or partially edentulous patients. Intended for delayed loading after 12 weeks.
Material Composition	Substantially equivalent (same material as predicate for implants; similar for abutments).	Unalloyed titanium per ISO 5832-2 (Implants), Titanium alloy per ISO 5832-3 (Abutments).
Surface Treatment	Substantially equivalent (same surface treatment as predicate).	Sandblasted Large grit Acid etched (SLA).
Design	Substantially equivalent (two-component, bone level, conical form; minor differences in thread design/pitch, diameter range, and connection types for abutments evaluated through performance testing).	conical form design, double lead thread, two vertical anti-rotation grooves, conical internal hex connection (implants). Various abutment designs (Straight, Angled, Multi-unit, Ball, Equator).
Biocompatibility	Meet applicable standards for biocompatibility (e.g., ISO 10993 series).	Test results and analyses found the material and manufacturing processes were biocompatible (Cytotoxicity, FMEA, SEM & EDX, Chemical Analysis).
Fatigue Testing	Durability of implant-abutment combinations acceptable per ISO 14801:2007.	Durability of Nucleoss Tpure Implant and Abutment combinations was acceptable, tested on worst-case combinations.
MRI Safety	Found to be MR Conditional following testing to relevant ASTM standards.	Found to be MR Conditional according to ASTM F2052-14, F2182-11a, and F2119-07.
Sterilization Validation (Implants)	Meet ISO 11137-2 for gamma irradiation to ensure a SAL of 10^-6; LAL testing per USP 85 and FDA Guidance; Shelf life testing per ASTM standards D4169-16, F1980-16, F1929-15, D5276-98, F88/F88M-15.	Sterilized using a validated gamma ray sterilization process to ensure SAL of 10^-6. LAL testing conducted. Shelf life testing conducted.
Sterilization Validation (Abutments, End-user)	Recommended end-user steam sterilization parameters validated in accordance with ISO 17665-1:2006 and ISO 17665-2:2009, as per FDA Guidance for Reprocessing Medical Devices.	Recommended end-user steam sterilization parameters were validated. Abutments are provided non-sterile.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable: This 510(k) submission relied on non-clinical (bench) testing and comparison to predicate devices, not clinical trials with "test sets" of patient data as understood in AI/ML performance evaluation. The testing involved materials and manufactured components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: Ground truth, in the context of expert consensus on patient data, is not relevant to this type of device submission for dental implants. Device performance was assessed via engineering and materials testing against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: Adjudication methods are typically for clinical study endpoints or expert review of diagnostic findings, which are not part of this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: MRMC studies are used for evaluating diagnostic performance, often for AI-assisted image interpretation. This device is a mechanical implant, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This device does not involve an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable: The "ground truth" for this device's safety and effectiveness is established by adherence to recognized engineering and biomaterials standards (e.g., ISO for fatigue, ASTM for MRI safety, ISO for sterilization), and comparison of its technological characteristics to legally marketed predicate devices.

8. The sample size for the training set

Not Applicable: There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not Applicable: There is no "training set" or associated ground truth for this type of medical device submission.

Summary

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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.

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

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Indications for Use

510(k) Number (if known) K160850

Device Name Nucleoss Tpure Implant System

Indications for Use (Describe)

Nucleoss Tpure Dental Implants are intended for delayed loading after 12 weeks.

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, IzmirTR-35477Turkey
Telephone:	90-232-799 0304
Fax Number:	90-232-799 0306
Contact Person:	Ezgi OZBUDAK
US Consultant:	CardioMed Device Consultants
Address:	1783 Forest Drive, #254Annapolis, 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

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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.

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.

V. INDICATIONS FOR USE

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

TechnologicalCharacteristics	SUBJECT DEVICE	PRIMARY PREDICATEDEVICE
	Nucleoss Tpure Dental Implant	Straumann Bone Level Tapered Implants(K140878)
Indications for Use	Indicated for surgical placement in the bone of themaxillary and/or mandibular arches to provide supportfor prosthetic restorations (crowns, bridges oroverdenture) in edentulous or partially edentulouspatients to restore a patients' chewing function.Nucleoss Tpure Dental Implants are intended for delayedloading after 12 weeks.Nucleoss Abutments and Prosthetic parts are intended foruse with Nucleoss Tpure Dental Implants in the maxillaryand/or mandibular arches to provide support for crowns,bridges or overdenture for edentulous or partiallyedentulous patients	Indicated for oral endosteal implantation in the upper andlower jaw and for the functional and esthetic oralrehabilitation of edentulous and partially dentate patients.Straumann dental implants can also be used for immediate orearly implantation following extraction or loss of naturalteeth. Implants can be placed with immediate function onsingle-tooth and/or multiple tooth applications when goodprimary stability is achieved and with appropriate occlusalloading, to restore chewing function. The prostheticrestorations used are single crowns, bridges and partial orfull dentures, which are connected to the implants by thecorresponding elements (abutments). In cases of fullyedentulous patients, 4 or more implants must be used inimmediately loaded cases.
Material	Grade 4 commercially pure titanium conforming withISO 5832-2	Grade 4 commercially pure titanium conforming with ISO5832- 2
Surface Treatment	Sand blasted Large grit Acid etched (SLA)	Sand blasted Large grit Acid etched (SLA)
Design	Two component / Bone level/Conical formTwo stage surgical techniqueFor single or multiple restorationsTpure Implant threads are designed in double lead threadform with two vertical anti-rotation grooves.Constant major and minor thread diameters (i.e., parallelwall) 0.75mm thread pitch.Angled major and minor thread diameters (i.e., taperedwall), with the major and minor diameters have differingangles such that the depth increases toward the apical endof the implant and the addition of cutting flutes 0.75mmthread pitch.	Two component / Bone level/Conical formTwo stage surgical techniqueFor single or multiple restorationsConstant major and minor thread diameters (i.e., parallelwall) 0.8mm thread pitch.Angled major and minor thread diameters (i.e., taperedwall), with the major and minor diameters have differingangles 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 internalhex connection with 80 degrees.
Transfer piece	Fixture-mount transfer part, intended to support theimplant while in the primary package, to aid in theremoval of the implant from the primary package, and toaid in placement of the implant into the osteotomy site.	Snap fit mount LoximTM transfer piece, intended to supportthe implant while in the primary package, to aid in theremoval of the implant from the primary package, and to aidin 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 PREDICATEDEVICE	REFERENCE PREDICATEDEVICE	REFERENCE PREDICATEDEVICE
	Nucleoss Abutment System	Klockner Dental ImplantAbutments (II)(K151194)	Klockner Dental ImplantAbutments(K122988)	Zimmer Zfx TitaniumAbutment for Biomet 3iCertain Implant System(K141544)
Material	Titanium alloy	Titanium alloyGold alloy & Co-Cr-Mo alloy(for Cast abutment)	Titanium Alloy	Titanium alloy
AbutmentDesign	Straight and Angled (10-30°):For single or multiple cementretained restorationsInternal hex connection.Multi-unit: For multiple screw-retained restorationsInternal hex connectionEquator and Ball:For overdenture restorationsInternal hex connection	Straight and Angled (10-30°):For multiple-unit screw-retained restorationsInternal octagonal coneconnectionCast: For single or multiple-unit cement-retainedrestorationsTemporary: For multiple-unitscrew-retained restorations	Straight and Angled (10-30°):For multiple-unit screw-retained restorationsInternal octagonal & externalhexagonal connection systemTemporary: For multiple-unitscrew-retained restorationsOverdenture:Screw-retainedBall attachment design	Patient-Specific: abutmentFor single or multiple screw-retained restorationsAngled Abutments (10-30°)Internal hex connection
AbutmentPlatformDiameter (mm)	Straight & Angled: 4.2, 5.0, 6.0Ball: 4.5Multi-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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PlatformHeights(mm)	Angled: 1.0, 2.0, 3.0, 4.0Multi-unit: 0°: 1.5, 3.0, 5.017°:1.5-3.1 & 2.4-4.030°:1.25-4.0 & 2.0 - 4.75Ball & Equator: 1.5, 3.0, 5.0	1.0, 2.5 & 4.0Angled: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

TechnologicalCharacteristics	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 screwedon the implant to cover the implant.Gingiva Former and Cover are color codedaccording to their platform diameter.	The devices are available in one and two-piece assemblies, and invarious diameters and heights.Healing abutment, closure cap and closure screw are color coded;yellow and purple.
	PlatformDiameter (mm)	Gingiva Former: 4.2, 5.0, 6.0Cover: 4.2, 5.0, 6.0
PlatformHeights (mm)	Gingiva Former: 2.0, 4.0, 6.0Cover: 0	Healing abutment: 2.0, 4.0, 6.0Closure 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.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Andrew I. Steen -S

Indications for Use

Indications for Use (Describe)

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510(k) SUMMARY (21 CFR 807.92)

I. SUBMITTER

II. DEVICE

III. PREDICATE DEVICE

Reference Predicate devices:

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Substantial Equivalence Comparison – Nucleoss Tpure Dental Implant

Substantial Equivalence Comparison - Nucleoss Dental Abutments

Substantial Equivalence Comparison – Nucleoss Gingiva Former and Cover

VII. PERFORMANCE DATA

Biocompatibility

Fatigue Testing

MRI Safety

Sterilization Validation

VIII. CONCLUSION

§ 872.3640 Endosseous dental implant.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW