The TRU 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 TRU Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.

The TRU Implant System is only intended for use with straight abutments. The TRU implant body is intended to be placed such no angle correction is necessary.

Device Description

The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube. A special driver is available for the implants which simplant insertion by eliminating the need for an implant mount.

The proposed TRU Dental Implant will be available in a range of lengths and diameters.

Thread Major Diameter (mm)	Overall Implant Length (mm)
3.5mm	8mm 10mm, 12mm, 14mm
4.3mm	8mm 10mm, 12mm, 14mm
5.0mm	8mm 10mm, 12mm
6.0mm	8mm, 10mm

The prosthetic components for the TRU implant System include Healing abutments, Straight Abutments and UCLA Abutments.

AI/ML Overview

This report summarizes the acceptance criteria and study information for the TRU Dental Implant System based on the provided FDA 510(k) summary (K150968).

Acceptance Criteria and Device Performance

The document does not explicitly present a table of quantitative acceptance criteria or specific device performance metrics in numerical form. Instead, the substantial equivalence determination relies on comparison of technological characteristics and confirmation of appropriate performance through non-clinical testing.

The "Performance Testing" section states: "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."

Therefore, the acceptance criteria implicitly derived are that the device's technological characteristics and performance meet or are substantially equivalent to the predicate devices and the relevant FDA guidance document for root-form endosseous dental implants.

Table of Implicit Acceptance Criteria and Reported Device "Performance" (via Equivalence)

Category	Implicit Acceptance Criterion (Based on Predicate and Guidance)	Reported Device Performance (as stated in 510(k) summary)
Intended Use	The device's intended use should be the same or substantially equivalent to predicate devices for oral rehabilitation of edentulous and partially dentate patients, with similar loading indications.	"The TRU 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 TRU Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading." (Identical to predicate Nobel Active, and similar to Sterngold Acid Etch). Also specifies "only intended for use with straight abutments" and "implant body is intended to be placed such no angle correction is necessary."
Material	Material should be implantable-grade titanium, similar to predicate devices.	"Wrought Titanium 6AL-4V ELI" for the TRU implant. (Predicate devices use "CP Titanium titanium grade 4"). The document states: "Any differences between the proposed devices and predicate devices do not render the device NSE." and "The materials, technology and processes used to produce the TRU dental implants and abutments are the same as other Sterngold Dental devices previously cleared by the FDA."
Design	Design features (e.g., self-tapping, threaded, root-form, connection type, diameters, lengths, surface treatment) should be substantially equivalent or comparable to predicate devices.	"Self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched." Also provides detailed sizes. "Internal Connection" (Primary Predicate is Internal Connection, Reference Predicate is External Connection). "The proposed TRU Dental Implant will be available in a range of lengths and diameters." (Detailed in table on page 3). "The implant body is not intended to be placed with any angle correction."
Surface Treatment	Surface treatment characteristics (e.g., blasted with aluminum oxide, acid etched) should be the same as or equivalent to predicate devices, particularly the acid-etched predicate.	"Blasted with aluminum oxide particles and acid etched" (Identical to both predicate devices). "In addition the surface treatment is identical to the cleared Sterngold Acid Etched Implant (K023580)."
Sterility	The device should be supplied sterile, with a verified sterilization process, radiation dose, and shelf life.	"Supplied Sterile: Yes." "Proposed devices have the same sterilization process and radiation dose, same shelf life and biocompatibility as previous cleared Sterngold devices, therefore sterility, shelf life and bio-compatibility testing performed on previous cleared Sterngold devices is applicable to the proposed new devices."
Biocompatibility	The device should be biocompatible.	"Proposed devices have the same...biocompatibility as previous cleared Sterngold devices...biocompatibility testing performed on previous cleared Sterngold devices is applicable to the proposed new devices."
Mechanical Performance (Fatigue)	The device should withstand anticipated physiological forces. Guidance document requirements for fatigue (if applicable) should be met.	"Fatigue testing is not required because design features and technological features are similar to predicate devices; the implant body is not intended to be placed with any angle correction, and this submission does not contain any abutments for angle correction." This implies that the device's design, given its constraint of straight abutments and no angle correction, is deemed to operate safely based on the equivalence to predicate devices which have established fatigue performance.
Overall Performance	The device should perform appropriately for its intended use, based on non-clinical testing and comparison to predicates.	"Performance testing demonstrated that the device performs appropriately for the proposed indications for use." "Based on the above analysis, technological characteristics and performance testing, the subject device is substantially equivalent in intended use, material, design and performance to its predicates."

Study Details

The provided document describes a non-clinical study to demonstrate substantial equivalence, rather than a clinical trial with patient outcomes.

Sample size used for the test set and the data provenance:
- The document describes non-clinical testing, which typically does not involve human subjects or a "test set" in the sense of patient data.
- The "test set" implicitly refers to the specific configurations and types of implants and abutments manufactured for performance testing, as detailed in the product description (e.g., various diameters and lengths).
- Data Provenance: Not applicable in the context of human data. The testing refers to laboratory-based, non-clinical evaluations.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical, laboratory-based study for demonstrating device performance and equivalence against established standards and predicate devices. No human 'ground truth' experts were involved in evaluating test outcomes in the way they would be for diagnostic accuracy studies. The "ground truth" here is compliance with engineering and material standards and performance comparable to established predicate devices.
Adjudication method for the test set:
- Not applicable. As a non-clinical performance study, there's no "adjudication" in the sense of reconciling disagreements among human readers or evaluators. The results would be objectively measured physical properties and performance characteristics.
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:
- No. This is a medical device for implantation, not an AI/diagnostic software. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a medical device, not an algorithm or AI. The performance testing is inherent to the physical device.
The type of ground truth used:
- The "ground truth" for this substantial equivalence determination is conformance to recognized standards, engineering specifications, and established safe and effective performance of the predicate devices.
- This includes:
  - Compliance with 21 CFR 872.3640 (Endosseous Dental Implant regulation)
  - Adherence to "Guidance for Industry and FDA Staff -Class 11 Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments."
  - Demonstrated equivalence of technological characteristics (material, design, dimensions, surface treatment, intended use, etc.) to the identified predicate devices (Nobel Active Internal Connection Implant (K071370) and Sterngold Acid Etch Dental Implant System (K023580)).
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. No training set was used.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, stacked on top of each other.

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

July 24,2015

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

Re: K150968

Trade/Device Name: TRU Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 26, 2015 Received: June 30, 2015

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.

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

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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 (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 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,

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): _K150968

Device Name: TRU Dental Implant System

Indications for Use:

The TRU Implant System is only intended for use with straight abutments. The TRU implant body is intended to be placed such no angle correction is necessary.

(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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K150968 510(k) Summary

Trade Name:	TRU Dental Implant System
Sponsor:	Sterngold Dental, LLC23 Frank Mossberg DriveAttleboro, MA 02703
	Contact: Maria Rao, QA/RA DirectorPh: 508-226-5660 ext 1206
Date:	July 23, 2015
Device Generic Name:	Endosseous Dental Implant

Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II

Product Code: DZE (21CFR 872.3640) NHA (21CFR 872.3630)

Predicate Devices:

The TRU 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, and Nobel Active Internal Connection Implant System.

Product Description:

The proposed TRU Dental Implant will be available in a range of lengths and diameters.

Thread Major Diameter (mm)	Overall Implant Length (mm)
3.5mm	8mm 10mm, 12mm, 14mm
4.3mm	8mm 10mm, 12mm, 14mm
5.0mm	8mm 10mm, 12mm
6.0mm	8mm, 10mm

The prosthetic components for the TRU implant System include Healing abutments, Straight Abutments and UCLA Abutments.

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Healing Abutments are intended for placement onto the implant. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase.

Straight Abutments attach directly to the implant and provide the transitional link between the head of the implant and the restorative components. They are designed to be used for screw retained multiimplant prostheses. They are available in a narrow platform with 1.5mm and a 3.0mm cuff size and in a regular platform with 1.5mm and a 3.0mm cuff size.

UCLA Abutments attach directly to the implant and provide a pattern for the creation of a screw retained veneered crown. They are available with two apical (bottom) ends; one with a hex to engage the hex of the implant and one without a hex that does not engage the implant. The engaging/hexed abutment is used on restoration of a single tooth to prevent rotation of the completed crown, and the non-engaging/non-hexed is used on multiple tooth restorations.

Indications for Use:

The TRU Implant System is only intended for use with straight abutments. The TRU implant body is intended to be placed such no angle correction is necessary.

Substantial Equivalence:

The proposed TRU 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 Indications for Use, basic design, fundamental operating principles are the same or similar as the predicate devices.

. Nobel Active Internal Connection Implant (K071370) - Primary Predicate
Sterngold Acid Etch Dental Implant System (K023580) Reference Predicate ●

Compatibility and substantial equivalency was determined by comparing the design features including diameters, lengths, cuff sizes, materials, implant-to-abutment connection platform, implant surface texture, abutment fixation method, and intended use of proposed device to predicate devices.

Any differences between the proposed devices and predicate devices do not render the device NSE.

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Technological Characteristics:

The TRU dental Implant provides the same or similar functions as well as design and technological characteristics as the predicate devices. In addition the surface treatment is identical to the cleared Sterngold Acid Etched Implant (K023580).

The materials, technology and processes used to produce the TRU dental implants and abutments are the same as other Sterngold Dental devices previously cleared by the FDA.

See Substantial Equivalence Comparison table below.

Property	TRU DentalImplant System(Proposed Device)	Nobel Active Internal Connection Implant(K071370)Primary Predicate	Sterngold Acid Etch DentalImplant System(K023580)Reference Predicate
ImplantDesign	Self-tapping, threaded, Root-formimplant	Self-tapping, threaded, Root-form implant	Self-tapping, threaded, Root-form implant
Implant Sizesdiameter xlength	3.5x8mm,10mm,12mm,14mm4.3x8mm,10mm,12mm,14mm5.0mmx8mm,10mm,12mm6.0mmx8mm,10mm,12mm	3.5x8.5mm,10mm,11.5mm,13mm,15mm4.3x8.5mm,10mm,11.5mm,13mm,15mm	3.3x10mm,11.5mm,13mm4.0x8.5mm,10mm,11.5mm,13mm,15mm5.0x8.5mm,10mm
AbutmentCompatibility	Internal Connection	Internal Connection	External Connection
Implant Stage	Stage 1 and Stage 2	Stage 1 and Stage 2	Stage 1 and Stage 2
PlacementAccessories	Implant drills, countersinks, bone taps	Implant drills, countersinks, bone taps	Implant drills, countersinks,bone taps
SuppliedSterile	Yes	Yes	Yes
Intended Use	Implant applications for oralrehabilitation of edentulous andpartially dentate patients in the maxillaand mandible. Implant retainedrestorations may consist of singlecrowns or bridges as well as completeor partial dentures.	Long term surgical implantation in the bone ofthe patient's upper or lower arch to provideimmediate load or delayed load of prostheticsystems, such as artificial teeth, in order torestore the patient's chewing function. Alsoindicated for for immediate loading with goodprimary stability and appropriate occlusalloading.	Implantation into any area ofthe partially and/or fullyedentulous maxilla andmandible for the support of aremovable or fixed dentalprosthesis. Intended for singletooth or multiple unitprosthesis.
ImplantMaterial	Wrought Titanium 6AL-4V ELI	CP Titanium titanium grade 4	CP Titanium titanium grade 4
ImplantSurface	Blasted with aluminum oxide particlesand acid etched	Blasted with aluminum oxide particles and acidetched	Blasted with aluminum oxideparticles and acid etched

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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.

Fatigue testing is not required because design features and technological features are similar to predicate devices; the implant body is not intended to be placed with any angle correction, and this submission does not contain any abutments for angle correction.

Proposed devices have the same sterilization process and radiation dose, same shelf life and biocompatibility as previous cleared Sterngold devices, therefore sterility, shelf life and bio-compatibility testing performed on previous cleared Sterngold devices is applicable to the proposed new devices. As a result, the TRU Dental Implant System including abutments is substantial equivalent to the predicates.

Conclusion:

Based on the above analysis, technological characteristics and performance testing, the subject device is substantially equivalent in intended use, material, design and performance to its predicates.

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.