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

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

Device Description

The PUR is a self-tapping, double thread screw implant with a micro groove section, manufactured from Wrought Titanium 6AL-4V ELI. The implant surface is grit-blasted and acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, and 6.0 mm. The 3.5 and 4.3 mm implants have a Narrow Platform (NP) prosthetic head. The 5.0 and 6.0 mm implants have a Regular Platform (RP) prosthetic head. The PUR implants are substantially equivalent to the Zimmer Tapered Screw-Vent® 3.5 mmD Platform and the 4.5 mmD Platform implant systems. 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 simplifies implant insertion by eliminating the need for an implant mount.

This device uses straight abutments with no angles. Sterngold has SA Abutments) which are intended for multi-unit restorations. Sterngold also has UCLA abutments which are twopiece abutments composed of Wrought Titanium 6AL-4V ELI, conforming to ASTM F136-13 and Gold Alloy (64% gold, 22% palladium and 14.0% platinum). These UCLA abutments are intended for single and multiple unit use.

The PUR implant system is not intended to include any angled abutments or allow for any correction of angled implant placement.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental implant system. This type of document is used to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device, meaning it is at least as safe and effective. The FDA's decision is based on comparing the new device's technological characteristics and intended use to those of the predicate.

Crucially, a 510(k) summary for a dental implant system typically does not include "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way one might find for an AI/ML-driven diagnostic device. The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC is not directly applicable here. Instead, the "acceptance criteria" for a 510(k) are related to demonstrating substantial equivalence through various tests (mechanical, biocompatibility, sterilization validation) and design comparisons.

Therefore, many of the requested points are not applicable to this type of regulatory submission. However, I will extract and describe the relevant information that is present.

Here's an analysis based on the provided text, addressing the points where possible and indicating when they are not applicable for this kind of device and submission:

1. A table of acceptance criteria and the reported device performance

As explained above, this submission does not present acceptance criteria and performance in terms of diagnostic metrics (e.g., sensitivity, specificity, or F1 score). Instead, the "performance" demonstrated for dental implants revolves around mechanical properties, biocompatibility, and sterilization effectiveness to show substantial equivalence to predicate devices.

The document states:

Performance Testing: "Non clinical Testing was performed following "Guidance for Industry and FDA Staff -Class II 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."
Surface analysis: "SEM photographs confirm that all residue of blasting material had been removed from the treated implant surface, and the surface chemical analysis confirmed that no contaminants remained on the surface."
Sterilization, shelf life, and biocompatibility: "PUR Implants have the same sterilization process and radiation dose, same shelf life and biocompatibility as previous cleared Sterngold devices, therefore sterility, shelf life and biocompatibility testing performed on previous cleared Sterngold devices is applicable to the PUR Implants."

Table of Comparison (extract of relevant parts from page 6, representing "performance" in the context of substantial equivalence):

Property	Subject Device K151928	Predicate Device K061410 (Primary Predicate)
Intended Use	The PUR 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 PUR Implant is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading. The PUR Implant System is only intended for use with straight abutments. The PUR implant body is intended to be placed such no angle correction is necessary.	For use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Implant Design	Threaded, Root-form implant	Threaded, Root-form implant
Implant Shape	Cylinder	Cylinder
Implant Body Diameter	3.5mm, 4.3mm, 5.0mm, 6.0mm	3.7mm, 4.1mm, 4.7mm, 6.0mm
Implant Length	8mm, 10mm, 12mm, 14mm	10.0mm, 11.5mm, 13.0mm, 16.0mm
Outer Thread	0.136 - 0.140	(Information not provided in table for predicate)

The "acceptance criteria" here are that the subject device's characteristics and performance testing results are comparable to the predicates and meet the established guidance standards for dental implants, demonstrating that it is as safe and effective.

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

This information is not provided in the document. The testing described is "non-clinical testing," which typically refers to benchtop mechanical tests or material characterization rather than human subject trials. Therefore, concepts like "test set" in the context of patient data, data provenance, or retrospective/prospective studies are not applicable.

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)

This is not applicable. The device is a physical dental implant, not a diagnostic AI/ML device requiring expert-labeled medical images for ground truth.

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

This is not applicable. As above, there is no "test set" in the context of expert adjudication for diagnostic accuracy.

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

This is not applicable. This is a physical medical device (dental implant), not an AI/ML software device.

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

This is not applicable. This is a physical medical device (dental implant), not an AI/ML software device.

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

For a physical device like a dental implant, "ground truth" refers to its physical, mechanical, and biological properties meeting established standards and performance expectations. The document indicates:

"Non clinical Testing was performed following 'Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.'" This guidance document essentially defines the "ground truth" or standard for performance.
"Surface analysis was conducted on the final device. SEM photographs confirm that all residue of blasting material had been removed from the treated implant surface, and the surface chemical analysis confirmed that no contaminants remained on the surface." This refers to chemical and microscopy analysis.
The reliance on "sterility, shelf life and biocompatibility testing performed on previous cleared Sterngold devices" based on the subject device having the "same sterilization process and radiation dose, same shelf life and biocompatibility." This means previous testing results and established biological safety are the "ground truth."

8. The sample size for the training set

This is not applicable. This is a physical medical device (dental implant), not an AI/ML software device that relies on a "training set."

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

This is not applicable. As above, there is no "training set" for device performance in this context.

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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three human profiles facing to the right.

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

November 6, 2015

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

Re: K151928

Trade/Device Name: PUR Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 29, 2015 Received: September 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 mav 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,

Erin | Keith -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

Enclosure

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510(k) Number (if known): K151928

PUR Implant System Device Name:

Indications for Use:

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

The PUR Implant System is only intended for use with straight abutments. The PUR 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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510(k) Summary

Trade Name:	PUR Implant System
Sponsor:	Sterngold Dental, LLC23 Frank Mossberg DriveAttleboro, MA 02703
	Contact: Maria Rao, QA/RA DirectorPh: 508-226-5660 ext 1206
Date:	November 1, 2015
Device Generic Name:	Dental endosseous implant system

Classification: 21 CFR 872.3640. Endosseous dental implant, Class II

Product Code: DZE, NHA

Predicate Devices:

The PUR 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.

Zimmer Dental Implants (K061410) - Primary Predicate
Screw Vent and Tapered Screw-Vent® (K013227) Reference Predicate ●
Sterngold Acid Etch Dental Implant System (K023580) Reference Predicate ●
. Implamed UCLA Abutments and Accessories (K933193) - Reference Predicate

Product Description:

The PUR implant system is not intended to include any angled abutments or allow for any correction of angled implant placement.

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The PUR 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

Dimensional requirements for the finished abutment:

Angulation of final abutment: No angles Minimum and Maximum Gingival Height: 1.5 - 3.0mm Minimum abutment post height may be fabricated to: 4.0mm

Indications for Use:

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

Substantial Equivalence:

The proposed PUR 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. While the Indications for Use statements are not identical between the subject and referenced predicates, the difference in verbiage does not alter the intended use of the subject device. The subject and reference devices all provide oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Both the subject device and its primary predicate are intended for delayed loading as well as immediate loading when there is good primary stability and an appropriate occlusal load. Therefore, the differences noted between the subject and predicates Indications for Use verbiage do not render the subject device as not substantially equivalent to its referenced predicates. The intended use, basic design, fundamental operating principles, sterilization process, shelf life and bio-compatibility of the subject device are equivalent to the predicate devices.

Technological Characteristics:

The PUR dental Implant provides the same or similar functions as well as design and technological characteristics as its predicate devices. In addition, the subject device is identical to the cleared Sterngold Acid Etched Implant (K023580).

The abutments for the subject device are the same or similar to the predicate devices, in terms of intended use, design and function. The materials, technology and processes used to produce the PUR dental implants and abutments are the same as other Sterngold Dental devices previously cleared by the FDA. Any differences between the proposed devices and its predicates do not affect the substantial equivalence. See the comparison chart below for list of similarities and differences.

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Performance Testing:

Non clinical Testing was performed following "Guidance for Industry and FDA Staff -Class II 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.

Surface analysis was conducted on the final device. SEM photographs confirm that all residue of blasting material had been removed from the treated implant surface, and the surface chemical analysis confirmed that no contaminants remained on the surface.

PUR Implants have the same sterilization process and radiation dose, same shelf life and biocompatibility as previous cleared Sterngold devices, therefore sterility, shelf life and biocompatibility testing performed on previous cleared Sterngold devices is applicable to the PUR Implants. As a result, the PUR Implant System including abutments is substantial equivalent to its predicates.

Conclusion:

Based on our analysis, technological characteristics and performance testing, the PUR Implant System is substantially equivalent in intended use, material, design and performance to its predicates.

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Property	Subject DeviceK151928	Predicate DeviceK061410	Predicate DeviceK013227	Predicate DeviceK023580	Predicate DeviceK933193
Intended Use	The PUR Implant System can be used in dentalimplant applications, for oral rehabilitation ofedentulous and partially dentate patients in themaxilla and mandible. Implant retained restorationsmay consist of single crowns or bridges as well ascomplete or partial dentures. The PUR Implant isintended for delayed loading. It is also indicated forimmediate loading with good primary stability andappropriate occlusal loading. The PUR ImplantSystem is only intended for use with straightabutments. The PUR implant body is intended to beplaced such no angle correction is necessary.	For use in the maxilla or mandiblefor immediate loading or for loadingafter a conventional healing period.Implants may be used to replace one ormore missing teeth. Immediate loadingis indicated when there is good primarystability and an appropriate occlusalload.	For use in edentulous mandible andmaxilla for attachment of completedenture prostheses, or as a terminal orintermediary abutment for fixed orremovable bridgework or as afreestanding single tooth replacement	Implantation into any area of thepartially and/or fully edentulousmaxilla and mandible for the supportof a removable or fixed dentalprosthesis. Intended for single tooth ormultiple unit prosthesis.	The UCLA Abutments areindicated for use whenfabricating bridges and singletooth restorations andattaching directly to theimplant.
Implant Design	Threaded, Root-form implant	Threaded, Root-form implant	Threaded, Root-form implant	Threaded, Root-form implant	N/A
Implant Shape	Cylinder	Cylinder	Cylinder	Cylinder	N/A
Implant BodyDiameter	3.5mm, 4.3mm, 5.0mm, 6.0mm	3.7mm, 4.1mm, 4.7mm, 6.0mm	3.7mm, 4.1mm, 4.7mm, 6.0mm	3.3mm, 4.0mm, 5.0mm	N/A
Implant Length	8mm, 10mm, 12mm, 14mm	10.0mm, 11.5mm, 13.0mm,16.0mm	8.0mm, 10.0mm, 11.5mm,13.0mm, 16.0mm	8.5mm, 10.0mm, 11.5mm,13.0mm, 15.0mm	N/A
Outer Thread	0.136 - 0.140

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.