The Stern AC Dental Implant System can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The Stern AC Dental Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.

The Stern AC Dental Implants are compatible with the Straumann Rn Synocta, Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, Straumann RC Cementable abutments and Stern IC Solid Abutments.

The Stern AC Dental Implant System is only intended for use with straight abutments.

Device Description

The proposed implant is a self-tapping, double thread screw implant, manufactured from pure grade 4 titanium. The implant is acid etched except for the neck, which is machined to a smooth finish. Stern AC Implants are manufactured with a flared neck, used for one-stage, transgingival implantation. The neck and body include an internal taper and octagon. The implants are manufactured with three body diameters, 3.3 mm, 4.0 mm, and 5.0 mm, all with the same prosthetic head.

The proposed implants are prosthetically compatible with the Straumann ITI implant system and the Stern IC Dental Implant System previously approved for market:

Straumann Rn Synocta - K073628 Straumann SynOcta Meso Abutments - K033243 Straumann RC Temporary Abutments - K093027 Straumann RC Cementable abutments - K072071 Stern IC Solid Abutments - K111798

They are packaged sterile in a double blister, which contains implant with an implant mount screw secured in a titanium tube. The Mount Body is screwed into the using the mount screw, which keeps it in place. This configuration is known as "Direct Delivery", which allows the surgeon to transport the implant from the package to the prepared implant site and save chairside time. The proposed Stern AC Dental Implant will be available in a range of lengths and diameters.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Stern AC Dental Implant System. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document.

However, based on the information provided, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria or quantifiable performance metrics for the Stern AC Dental Implant System. Instead, the "performance" demonstrated is that the device is "substantially equivalent" to predicate devices and "performs appropriately for the proposed indications for use." The performance testing mentioned is primarily non-clinical, focusing on material and design characteristics.

Property/Characteristic	Acceptance Criteria	Reported Device Performance
Intended Use	Similar to predicate devices	Aligns with predicate devices (Sterngold Acid Etch Dental Implant System (K023580) and Stern IC Dental Implant System (K111798)).
Material	Same as predicate devices	CP Titanium grade 4, same as predicate devices.
Design	Same or similar functions and characteristics as predicate devices	Self-tapping, double-thread screw implant, flared neck, internal taper and octagon. Prosthetically compatible with Straumann ITI and Stern IC systems.
Manufacturing Process	Same as predicate devices	Same manufacturing process as other Sterngold Dental Implants previously approved.
Surface Treatment	Same as predicate devices	Blasted with aluminum oxide particles and acid etched (identical to Sterngold Acid Etched Implant and widely used surface like Straumann "SLA").
Sterilization	Validated	Sterilization validation was conducted.
Blasting Residue	All residue removed	SEM photographs enclosed showing all residue of blasting material was removed from the surface.
Biocompatibility	Not explicitly stated, but implied by material similarity	CP Titanium grade 4, a commonly used and biocompatible material for dental implants.
Mechanical Strength/Fatigue	Not explicitly stated, but implied by "appropriate performance" for indications	Not detailed, but the document states "performs appropriately for the proposed indications for use" following the "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments."

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not applicable in the context of this document. The submission is based on demonstrating substantial equivalence through comparison of design, materials, and non-clinical performance to existing cleared devices, not on a clinical "test set" of patients or a defined dataset with ground truth for algorithm evaluation.
Data Provenance: The data provided primarily stems from the manufacturer's internal design specifications, material characterization, manufacturing process descriptions, and comparisons to predicate devices. It is entirely retrospective in the sense that it relies on existing knowledge and data for predicate devices and internal validation of the manufacturing processes and material properties of the new device. There is no mention of patient data, clinical trials, or external datasets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. There is no "test set" in the sense of a dataset requiring expert ground truth establishment for algorithm evaluation. The "ground truth" for this submission is FDA's existing clearances for predicate devices and established standards for dental implant materials and design.

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" requiring adjudication.

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 document describes a traditional medical device (dental implant) submission, not an AI/software as a medical device (SaMD) submission. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or reported.

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

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

The "ground truth" in this context is established by:
- Regulatory Precedent: The FDA's previous clearance of the predicate devices (Sterngold Acid Etch Dental Implant System (K023580) and Stern IC Dental Implant System (K111798)).
- Industry Standards: Adherence to guidance documents like "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments."
- Material Science Principles: The properties of CP Titanium grade 4 and the known performance of specific surface treatments (blasted with aluminum oxide particles and acid etched).
- Engineering Design Principles: The design features like self-tapping threads, flared neck, and internal connections are evaluated against known engineering principles for dental implants.
- Laboratory Testing: SEM photographs for blasting residue removal and sterilization validation results.

8. The Sample Size for the Training Set:

Not applicable. As this is not an AI/machine learning device, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no "training set" or ground truth for such a set.

Summary

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

January 7,2015

Sterngold Dental LLC Ms. Maria Rao Director of Regulatory Affairs 23 Frank Mossberg Drive Attleboro, Massachusetts 02703

Re: K142667

Trade/Device Name: Stern AC Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 11, 2014 Received: December 12, 2014

Dear Ms. Rao:

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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Page 2 - Ms. Rao

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,

Susan Runno DDS, MA

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

Enclosure

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510(k) Number (if known): __K142667

Device Name: Stern AC Dental Implant System

Indications for Use:

The Stern AC Dental Implant System is only intended for use with straight abutments.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Over-the -Counter Use (21 CFR 807 Subpart D)

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510(k) Summary

Trade Name: Stern AC Dental Implant System

Sponsor: Sterngold Dental, LLC 23 Frank Mossberg Drive Attleboro, MA 02703

Contact: Maria Rao, QA/RA Director Ph: 508-226-5660 ext 1206

Date: January 5, 2015

Device Generic Name: Endosseous Dental Implant system

Classification: Endosseous Dental Implant, 872.3640, Class II

Product Code: DZE

Predicate Devices:

The Stern AC Dental Implant System is substantially equivalent to other currently marketed dental implant systems that have been cleared by FDA through the 510(k) Premarket Notification process, including the Sterngold Acid Etch Dental Implant System (K023580), and Stern IC Dental Implant System (K111798).

Product Description:

The proposed implants are prosthetically compatible with the Straumann ITI implant system and the Stern IC Dental Implant System previously approved for market:

Straumann Rn Synocta - K073628 Straumann SynOcta Meso Abutments - K033243 Straumann RC Temporary Abutments - K093027 Straumann RC Cementable abutments - K072071 Stern IC Solid Abutments - K111798

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Thread Major Diameter (mm) 3.3mm 4.0 mm

Overall Implant Length (mm)

10.0, 11.5, 13.0mm 8.5, 10.0, 11.5, 13.0, 15.0mm 8.5, 10.0mm

The Stern AC Dental Implant System is not intended for correction of implant fixtures placed at an angle. It is only intended for use with straight abutments.

Indications for Use:

5.0mm

Substantial Equivalence:

The proposed Stern AC Dental implants are substantially equivalent to other currently marketed dental implant systems that have been cleared by FDA through the 510(k) Premarket Notification process. The intended use, basic design, fundamental operating principles are the same as the predicate devices.

. Stern IC Dental Implant System (K111798)
. Sterngold Acid Etch Dental Implant System (K023580)

Technological Characteristics:

The Stern AC dental Implant provides the same or similar functions as well as design and technological characteristics as the predicate devices listed. In addition the surface is identical to the cleared Sterngold Acid Etched Implant.

The materials, technology and facilities used to produce the Stern AC Dental Implants are the same as other Sterngold Dental Implants previously approved and cleared by FDA.

The proposed Stern AC dental implant has the same materials, same manufacturing process and surface treatment as previously cleared Sterngold Acid Etch dental implant and Stern IC Dental Implant. This surface is widely used in the industry primarily by the Straumann Company under the name "SLA".

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Property	Stern AC DentalImplant System(Proposed Device)	Sterngold Acid Etch DentalImplant System(K023580)	Sterngold Stern IC DentalImplant System(K111798)
Implant Design	Self-tapping, threaded, Root-form implant	Self-tapping, threaded, Root-form implant	Self-tapping, threaded, Root-form implant
Implant Sizes(diameter*) x (length)	3.3x10.0mm	3.75x8.5mm	3.3x1.8x8.0mm
	3.3x11.5mm3.3x13mm4.0x8.5mm4.0x10.0mm4.0x11.5mm4.0x13.0mm4.0x15.0mm5.0x8.5mm5.0x10.0mm	3.75x10.0mm3.75x11.5mm3.75x12.0mm3.75x13.0mm3.75x15mm4.0x8.5mm4.0x10.0mm4.0x13.0mm	3.3x1.8x10.0mm3.3x1.8x12.0mm3.3x1.8x14.0mm4.1x1.8x8.0mm4.1x1.8x10.0mm4.1x1.8x12.0mm4.1x1.8x14.0mm
AbutmentCompatibility	Internal Connection	External Connection	Internal Connection
Implant Stage	Stage 1 and Stage 2	Stage 1 and Stage 2	Stage 1 and Stage 2
External ScrewThreads	Yes	Yes	Yes
Placement Accessories	Implant drills, twist drills, countersinks, bonetaps, insertion tool	Implant drills, twist drills, countersinks, bonetaps, insertion tool	Implant drills, twist drills, countersinks, bone taps,insertion tool
Supplied Sterile	Yes	Yes	Yes
Intended Use	Dental implant applications for oralrehabilitation of edentulous and partially dentatepatients in the maxilla and mandible. Implantretained restorations may consist of singlecrowns or bridges as well as complete or partialdentures. The Stern AC Dental Implant Systemis intended for delayed loading. It is alsoindicated for immediate loading with goodprimary stability and appropriate occlusalloading.	Implantation into any area of the partially and/orfully edentulous maxilla and mandible for thesupport of a removable or fixed dentalprosthesis. Intended for single tooth or multipleunit prosthesis.	Long term surgical implantation in the bone of thepatient's upper or lower arch to provide immediate loador delayed load of prosthetic systems, such as artificialteeth, in order to restore the patient's chewing function.Also indicated for for immediate loading with goodprimary stability and appropriate occlusal loading
Implant Material	CP Titanium titanium grade 4	CP Titanium titanium grade 4	CP Titanium titanium grade 4
Implant Surface	Blasted with aluminum oxide particles and acidetched	Blasted with aluminum oxide particles and acidetched	Blasted with aluminum oxide particles and acid etched

Performance Testing:

Non clinical Testing was performed following "Guidance for Industry and FDA Staff -Class 11 Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Performance testing demonstrated that the device performs appropriately for the proposed indications for use. SEM photographs are enclosed showing all residue of blasting material was removed from the surface.

Sterilization validation was conducted on the proposed devices.

Conclusion:

Based on our analysis, the device is substantially equivalent in intended use, material, design and performance to its predicate devices, Sterngold Acid Etch Dental Implant System (K023580) and Stern IC Dental Implant System (K111798).

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.