The NaturaLLock implant system is an endosseous dental implant system made of titanium. NaturaLLock implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the molar, premolar, cuspid, and incisor regions of partially edentulous jaws. NaturaLLock implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. NaturaLLock implants may be immediately restored with a temporary prosthesis that is not in functional occlusion.

Device Description

The NaturaLLock single-stage implant for immediate restoration combines the endosteal and prosthetic implant sections in one piece (integrated abutment). The anatomically shaped implant has a self-tapping thread.

The NaturaLLock implant system includes single-stage implants, dental tools, instruments, drills, drill guide sleeves and a surgical tray, which contains a complete set of instruments structured according to the logical sequences of surgery.

The system is colour coded as follows: red Ø 3.5 mm, yellow Ø 4.3 mm, blue Ø 5.0 mm, green Ø 6.0 mm. The instruments are laser marked with the following information: drills: Ø and length, implant driver: Ø

AI/ML Overview

The provided document is a 510(k) Summary for the ZL Microdent NaturaLLock Implant System. It does not describe a study involving an AI/ML device, but rather a dental implant. Therefore, most of the requested information regarding AI/ML study details (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, and ground truth for training set) is not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the "Substantial Equivalence Comparison Table" and the "Summary of the non-clinical testing data" as it relates to the dental implant itself.

Here's the information derived from the document, focusing on the device's substantial equivalence to predicate devices:

1. Table of acceptance criteria and the reported device performance

For a 510(k) submission, "acceptance criteria" for demonstrating substantial equivalence are typically aligned with showing that the new device is as safe and effective as, and performs as well as predicate devices, and does not raise new questions of safety or effectiveness. The "reported device performance" is a demonstration of how the new device meets or is comparable to these aspects of the predicate devices.

Acceptance Criteria (Demonstrated by Equivalence to Predicate)	Reported Device Performance (ZL Microdent NaturaLLock Implant System)
Intended Use / Indications for Use: Similar functionality and indications as predicate devices. Ensure support and retention for fixed single tooth/partial denture restorations, immediate loading in specific cases, and immediate temporary restoration without functional occlusion.	The NaturaLLock implant system is an endosseous dental implant system made of titanium. NaturaLLock implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the molar, premolar, cuspid, and incisor regions of partially edentulous jaws. NaturaLLock implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. NaturaLLock implants may be immediately restored with a temporary prosthesis that is not in functional occlusion. (Result: s.e. - substantially equivalent)
Material: Composed of biocompatible material (e.g., titanium/titanium alloy)	ZL Microdent NaturaLLock implants are made of Titanium. (Result: s.e. - Identical to predicate device materials)
Target Population: Professional use by qualified dental implantologists, oral surgeons, or maxilla surgeons.	Professional use only - qualified dental implantologists, oral surgeons or maxilla surgeons only. Strictly reserved to specialised and trained users. (Result: s.e. - Identical to predicate device target population)
Where Used: Dental practices.	Dental practises. (Result: s.e. - Identical to predicate device usage environment)
Packaging: Appropriate for maintaining sterility and device integrity, with clear labeling.	The NaturaLLock implant packaging comprises a non-sterile storage packaging with instructions for use (paper), a secondary packaging as a germ barrier and implant holding unit (glass) and a sterile primary packaging (glass). The glass container is delivered with a sticker showing all relevant information. Furthermore the storage packaging includes a sandwich tag for transference to the patient file (LOT No.). (Result: s.e. - Similar to predicate device packaging)
Performance / Biocompatibility: Demonstrate biocompatibility according to ISO 10993 and comparable performance to predicate devices.	Testing according ISO 10993 Biological Evaluation of Medical Devices applying all relevant provisions for the devices. All relevant testing regarding biocompatibility was carried out by ZL Microdent-Attachment GmbH & Co. KG with a total compliance with the provisions of ISO 10993. The same material is used for the predicate devices manufactured and distributed by Nobel Biocare USA and Leader Italia, which received market clearance and are in commercial distribution. (Result: s.e. - Identical material and compliance with standards as predicate devices)
Sterilization: Sterile or sterilizable according to validated processes.	All implants are sold sterile. Drills, instruments and other invasive components are sold non sterile and need to be sterilized according to the manufacturers validated processing instructions. All components and instruments need to be sterilized prior to use. (Result: s.e. - Identical to predicate device sterilization approaches)
Sizes & Diameters: Available in a range of sizes and diameters comparable to predicate devices.	ZL Microdent NaturaLLock implants and its components are available in the following lengths and diameters: Ø 3.5 – lengths: 10, 13 & 16mm; Ø 4.3 – lengths: 8, 10, 13 & 16mm; Ø 5.0 – lengths: 8, 10, 13 & 16mm; Ø 6.0 – lengths: 8, 10, 13 & 16mm. (Result: s.e. - Comparable ranges to predicate devices)
Non-clinical Testing: Show safety and efficacy through relevant non-clinical tests (risk analysis, cleanliness, cytotoxicity, packaging, bench performance).	Results of risk analysis, case studies, cleanliness testing, biocompatibility, sterilization, cytotoxicity and packaging testing have demonstrated that ZL Microdent NaturaLLock implants are equivalent to the predicate device implants tested. When compared with predicate devices, results of bench performance testing indicated all acceptance criteria were met, and demonstrated the subject implants are equivalent. (Result: All acceptance criteria met, demonstrated equivalence and no new issues of safety/efficacy)

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 document describes a dental implant, not an AI/ML device. The "testing" referred to is laboratory and bench testing of the physical implant, not a clinical study involving a "test set" of patient data for AI/ML performance evaluation.

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: As above, this is not an AI/ML device study.

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

Not Applicable: As above, this is not an AI/ML device study.

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: This is not an AI/ML device.

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

Not Applicable: This is not an AI/ML device.

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

Not Applicable: For this physical device, "ground truth" in the AI/ML sense is not relevant. The "truth" is established by adherence to recognized standards (e.g., ISO 10993 for biocompatibility) and successful bench testing outcomes demonstrating properties like mechanical strength, sterility, and material composition, all compared to legally marketed predicate devices.

8. The sample size for the training set

Not Applicable: This is not an AI/ML device.

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

Not Applicable: This is not an AI/ML device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Auqust21, 2014

ZL Microdent Attachment GmbH Synnöve Lindeman Head of Quality Management Schutzenstrabe 6-8 Breckerfeld, DE D-58339

Re: K132585

Trade/Device Name: ZL Microdent Natural Lock Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseus Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: July 21, 2014 Received: July 24, 2014

Dear Ms. Lindeman:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indication for Use

510(k) Number:

Device Name: ZL Microdent NaturaLLock Implant System

Indications for use:

The implants are offered in sterile condition, all other components can be sterilized in an autoclave .

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of DCRH, Office of Device Evaluation (ODE)

Page 01 of 01

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Summary

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510(k) Summary as required by section 807.92(c)

K-number: K133706

Submission Applicant:

ZL Microdent-Attachment GmbH & Co. KG Schützenstraße 6-8 58339 Breckerfeld Germany

Phone: +49 (0)2338-801-0 Fax: +49 (0)2338-801-40 E-mail: Synnoeve.lindeman@zl-microdent.de

Establishment Registration Number:

3008134186

Application correspondent/Contact person:

Synnöve Lindeman Schützenstrasse 6-8 D-58339 Breckerfeld, Germany

Phone: +49 (0)2338 80143 Fax: +49 (0)2338 80140 E-mail: synnoeve.lindeman@zl-microdent.de

Trade name:

ZL Microdent NaturaLLock Implant System

Common name:

One-piece implant system

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Classification name:

Endosseous dental implant, Dental (21 CFR 872.3640- DZE)

Predicate devices:

K031345 Nobel Direct

Nobel Biocare USA Inc., 22715 Savi Ranch Parkway, Yorba Linda, CA 92887, USA

K062281 Zimmer One Piece, 4,7mm

K052997 Zimmer Once Piece

Zimmer Dental Inc., 1900 Aston Ave., Carlsbad, CA 92008, USA

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Substantial Equivalence Comparison Table

Relevant Areas	ZL Microdent -NaturaLLock implant system	Result	Nobel Biocare USA -Nobel Direct implant system	Zimmer Dental Inc. -One piece implant system
Intended UseIndications for use	The NaturaLLock implant system is anendosseous dental implant system made oftitanium. NaturaLLock implants are indicatedfor the support and retention of fixed singletooth and fixed partial denture restorations inthe molar, premolar, cuspid, and incisorregions of partially edentulous jaws.NaturaLLock implants may be loadedimmediately in the anterior mandibular arch iffour are splinted together with a bar.NaturaLLock implants may be immediatelyrestored with a temporary prosthesis that isnot in functional occlusion.	s.e.	The Nobel Biocare - Nobel Direct implantsystem is an endosseous dental implant systemmade of a material such as titanium or titaniumalloy, that is intended to be surgically placed inthe bone of the upper or lower jaw arches toprovide support for prosthetic devices, such asartificial teeth, in order to restore a patient'schewing function.	The Zimmer) Dental One-Piece Implant is aone-piece endosseous dentalimplant which is a combination of implant andabutment sections. Theimplant is composed of titanium alloy. Theabutment portion is pre-preparedand contoured for esthetic restoration. Theabutment portion of the implantfeatures a pre-prepared margin to facilitate therestoration process. Theimplant section is designed for ease ofimplantation and with greater surfacearea for osseointegration. The implant sectionsurface is treated to facilitateosseointegration. In addition, the implantsection is tapered with either doubleor triple-lead threads, depending upon theapical diameter.
Material	ZL Microdent NaturaLLock implants aremade of Titanium	s.e.	Identical	Identical
Target population	Professional use only - qualified dentalimplantologists, oral surgeons or maxillasurgeons only. Strictly reserved to specialisedand trained users.	s.e.	Identical	Identical
Where used	Dental practises	s.e.	Identical	Identical
Packaging	The NaturaLLock implant packagingcomprises a non-sterile storage packagingwith instructions for use (paper), a secondarypackaging as a germ barrier and implantholding unit (glass) and a sterile primarypackaging (glass)The glass container is delivered with a stickershowing all relevant information. Furthermorethe storage packaging includes a sandwich tagfor transference to the patient file (LOT No.)	s.e.	Similar	Similar
Relevant Areas	ZL Microdent –NaturaLLock implant system	Result	Nobel Biocare USA –Nobel Direct implant system	Zimmer Dental Inc. –One piece implant system
Performance /Biocompatibility	Testing according ISO 10993 BiologicalEvaluation of Medical Devices applying allrelevant provisions for the devices.All relevant testing regarding biocompatibilitywas carried out by ZL Micodent-AttachmentGmbH & Co. KG with a total compliancewith the provisions of ISO 10993.The same material is used for the predicatedevices manufactured and distributed byNobel Biocare USA and Leader Italia, whichreceived market clearance and are incommercial distribution.	s.e.	Identical	Identical
Sterilization	All implants are sold sterile. Drills,instruments and other invasive componentsare sold non sterile and need to be sterilizedaccording to the manufacturers validatedprocessing instructions. All components andinstruments need to be sterilized prior to use.	s.e.	Identical	Identical
Sizes & Diameters	ZL Microdent NaturaLLock implants and itscomponents are available in the followinglengths and diameters:Diameters & lengths:Ø 3.5 – lengths: 10, 13 & 16mmØ 4.3 – lengths: 8, 10, 13 & 16mmØ 5.0 – lengths: 8, 10, 13 & 16mmØ 6.0 – lengths: 8, 10, 13 & 16mm	s.e.	Nobel Biocare Nobel Direct implants and itscomponents are available in the followinglengths and diameters:Diameter:Ø 3.0, 3.5, 4.3, 5.0 and 6.0mmLength:8, 10, 13 and 16mm	Zimmer Once Piece Implants and itscomponents are available in the followinglengths and diameters:Diameter:Ø 3.0, 3.7 & 4.7mmLength:10, 11.5, 13 and 16mm

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Description of the device:

Indication range:

For single and multiple tooth replacement in the upper and lower jaw. Adequate bone quality, width and height must be available. It has to be proven carefully, if the systemic state of the patient is adequate for an implantation, and especially if there are any allergic reactions on the implant components as well as any prohibitive diseases (e.g. diabetes, smoker).

Indications for Use:

The NaturaLLock implant system is an endosseous dental implant system made of titanium. NaturaLLock implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the molar, cuspid, and incisor regions of partially edentulous jaws. NaturaLLock implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. NaturaLLock implants may be immediately restored with a temporary prosthesis that is not in functional occlusion.

Comparison with predicate devices:

The ZL Microdent product is similiar to the predicate devices in terms of technical characteristics, design, indications for use, target population, where it is used, performance, biocompatibility characteristics as well as sizes, surfaces and configurations. Similar as the Nobel and Zimmer predicate devices the ZL Microdent NaturaLLock implants are one-piece constructions, have an integral, pre-contoured abutment, a tapered implant body, a self-cutting thread and an implant head with symmetrical, axially directed grooves.

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Conclusion: The ZL Microdent product can be deemed substantially equivalent for its indicated use.

Summary of the non-clinical testing data:

Results of risk analysis, case studies, cleanliness testing, biocompatibility, sterilization, cytotoxicity and packaging testing have demonstrated that ZL Microdent NaturaLLock implants are equivalent to the predicate device implants tested. When compared with predicate devices, results of bench performance testing indicated all acceptance criteria were met, and demonstrated the subject implants are equivalent. A series of safety and performance testing were performed to demonstrate that the ZL Microdent NaturaLLock implants do not raise any new issues of safety and efficacy.

Summary:

The presented data that was conducted on the ZL Microdent products, shows in its results and in comparison to the predicate devices substantially equivalence to the predicate devices for their intended use. The used materials are well researched.

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.