PUR Dental Implant System

K151928 · Sterngold Dental, LLC · DZE · Nov 6, 2015 · Dental

Device Facts

• Record ID: K151928
• Device Name: PUR Dental Implant System
• Applicant: Sterngold Dental, LLC
• Product Code: DZE · Dental
• Decision Date: Nov 6, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

PUR Dental Implant System is a self-tapping, double-thread screw implant; used for oral rehabilitation of edentulous/partially dentate patients. Input: surgical placement into maxilla or mandible. Operation: device acts as endosseous anchor for dental prosthetics (crowns, bridges, dentures). Used by dentists/oral surgeons in clinical settings. Output: mechanical support for prosthetic restorations. Benefits: restores dental function/aesthetics. System includes titanium implants and straight abutments; requires no angle correction. Insertion simplified by specialized driver eliminating need for implant mount.

Clinical Evidence

Bench testing only. Performance testing followed FDA Class II Special Controls Guidance for Root-form Endosseous Dental Implants. Surface analysis via SEM confirmed removal of blasting material and absence of contaminants. Sterility, shelf life, and biocompatibility were established via reference to previously cleared Sterngold devices.

Technological Characteristics

Material: Wrought Titanium 6AL-4V ELI (ASTM F136-13) and Gold Alloy. Design: Self-tapping, double-thread screw, root-form cylinder. Surface: Grit-blasted and acid-etched. Diameters: 3.5mm, 4.3mm, 5.0mm, 6.0mm. Abutments: Straight only. Sterilization: Radiation. Connectivity: None (mechanical).

Indications for Use

Indicated for oral rehabilitation of edentulous and partially dentate patients (maxilla and mandible) requiring single crowns, bridges, or complete/partial dentures. Supports delayed or immediate loading (if primary stability and occlusal load are appropriate). Restricted to straight abutments; no angle correction.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Zimmer Dental Implants (K061410)
• Screw Vent and Tapered Screw-Vent (K013227)
• Sterngold Acid Etch Dental Implant System (K023580)
• Implamed UCLA Abutments and Accessories (K933193)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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, LLC<br>23 Frank Mossberg Drive<br>Attleboro, MA 02703 |
| | Contact: Maria Rao, QA/RA Director<br>Ph: 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 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.

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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 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.

#### 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 Device<br>K151928 | Predicate Device<br>K061410 | Predicate Device<br>K013227 | Predicate Device<br>K023580 | Predicate Device<br>K933193 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The PUR Implant System can be used in dental<br>implant applications, for oral rehabilitation of<br>edentulous and partially dentate patients in the<br>maxilla and mandible. Implant retained restorations<br>may consist of single crowns or bridges as well as<br>complete or partial dentures. The PUR Implant is<br>intended for delayed loading. It is also indicated for<br>immediate loading with good primary stability and<br>appropriate occlusal loading. The PUR Implant<br>System is only intended for use with straight<br>abutments. The PUR implant body is intended to be<br>placed such no angle correction is necessary. | For use in the maxilla or mandible<br>for immediate loading or for loading<br>after a conventional healing period.<br>Implants may be used to replace one or<br>more missing teeth. Immediate loading<br>is indicated when there is good primary<br>stability and an appropriate occlusal<br>load. | For use in edentulous mandible and<br>maxilla for attachment of complete<br>denture prostheses, or as a terminal or<br>intermediary abutment for fixed or<br>removable bridgework or as a<br>freestanding single tooth replacement | Implantation into any area of the<br>partially and/or fully edentulous<br>maxilla and mandible for the support<br>of a removable or fixed dental<br>prosthesis. Intended for single tooth or<br>multiple unit prosthesis. | The UCLA Abutments are<br>indicated for use when<br>fabricating bridges and single<br>tooth restorations and<br>attaching directly to the<br>implant. |
| 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 Body<br>Diameter | 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,<br>16.0mm | 8.0mm, 10.0mm, 11.5mm,<br>13.0mm, 16.0mm | 8.5mm, 10.0mm, 11.5mm,<br>13.0mm, 15.0mm | N/A |
| Outer Thread | 0.136 - 0.140 | | | | |