Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm

K142667 · Sterngold Dental, LLC · DZE · Jan 7, 2015 · Dental

Device Facts

• Record ID: K142667
• Device Name: Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm
• Applicant: Sterngold Dental, LLC
• Product Code: DZE · Dental
• Decision Date: Jan 7, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Self-tapping, double-thread, root-form dental implant; manufactured from grade 4 titanium; features flared neck for one-stage, transgingival implantation; internal taper and octagon connection. Used by dental surgeons in clinical settings for oral rehabilitation. Packaged with mount screw in titanium tube for 'Direct Delivery' to implant site. Compatible with specific Straumann and Stern IC abutments. Provides foundation for single crowns, bridges, or dentures. Benefits patients by restoring chewing function and aesthetics. Not intended for angled fixtures; restricted to straight abutments.

Clinical Evidence

Bench testing only. Performance testing conducted per FDA guidance for root-form endosseous dental implants. SEM analysis confirmed removal of blasting material residues. Sterilization validation performed.

Technological Characteristics

Material: Grade 4 CP Titanium. Design: Self-tapping, threaded, root-form. Surface: Blasted with aluminum oxide and acid-etched. Connection: Internal taper and octagon. Form factor: 3.3mm, 4.0mm, 5.0mm diameters; various lengths. Sterilization: Sterile (double blister).

Indications for Use

Indicated for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible requiring single crowns, bridges, or complete/partial dentures. Suitable for delayed or immediate loading given good primary stability and appropriate occlusal loading.

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

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

Reference Devices

• Straumann Rn Synocta (K073628)
• Straumann SynOcta Meso Abutments (K033243)
• Straumann RC Temporary Abutments (K093027)
• Straumann RC Cementable abutments (K072071)

Submission Summary (Full Text)

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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 a stylized depiction of a human figure in profile, with three overlapping faces suggesting community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

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 [phone] or [phone] 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 [phone] or [phone] 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 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.

# (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 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.

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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

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.

### 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 Dental<br>Implant System<br>(Proposed Device) | Sterngold Acid Etch Dental<br>Implant System<br>(K023580) | Sterngold Stern IC Dental<br>Implant System<br>(K111798) |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implant Design | Self-tapping, threaded, Root-form implant | Self-tapping, threaded, Root-form implant | Self-tapping, threaded, Root-form implant |
| Implant Sizes<br>(diameter*) x (length) | 3.3x10.0mm | 3.75x8.5mm | 3.3x1.8x8.0mm |
| | 3.3x11.5mm<br>3.3x13mm<br>4.0x8.5mm<br>4.0x10.0mm<br>4.0x11.5mm<br>4.0x13.0mm<br>4.0x15.0mm<br>5.0x8.5mm<br>5.0x10.0mm | 3.75x10.0mm<br>3.75x11.5mm<br>3.75x12.0mm<br>3.75x13.0mm<br>3.75x15mm<br>4.0x8.5mm<br>4.0x10.0mm<br>4.0x13.0mm | 3.3x1.8x10.0mm<br>3.3x1.8x12.0mm<br>3.3x1.8x14.0mm<br>4.1x1.8x8.0mm<br>4.1x1.8x10.0mm<br>4.1x1.8x12.0mm<br>4.1x1.8x14.0mm |
| Abutment<br>Compatibility | Internal Connection | External Connection | Internal Connection |
| Implant Stage | Stage 1 and Stage 2 | Stage 1 and Stage 2 | Stage 1 and Stage 2 |
| External Screw<br>Threads | Yes | Yes | Yes |
| Placement Accessories | Implant drills, twist drills, countersinks, bone<br>taps, insertion tool | Implant drills, twist drills, countersinks, bone<br>taps, insertion tool | Implant drills, twist drills, countersinks, bone taps,<br>insertion tool |
| Supplied Sterile | Yes | Yes | Yes |
| Intended Use | Dental implant applications for oral<br>rehabilitation of edentulous and partially dentate<br>patients in the maxilla and mandible. Implant<br>retained restorations may consist of single<br>crowns or bridges as well as complete or partial<br>dentures. The Stern AC Dental Implant System<br>is intended for delayed loading. It is also<br>indicated for immediate loading with good<br>primary stability and appropriate occlusal<br>loading. | Implantation into any area of the partially and/or<br>fully edentulous maxilla and mandible for the<br>support of a removable or fixed dental<br>prosthesis. Intended for single tooth or multiple<br>unit prosthesis. | Long term surgical implantation in the bone of the<br>patient's upper or lower arch to provide immediate load<br>or delayed load of prosthetic systems, such as artificial<br>teeth, in order to restore the patient's chewing function.<br>Also indicated for for immediate loading with good<br>primary 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 acid<br>etched | Blasted with aluminum oxide particles and acid<br>etched | 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).