Insight Dental System

K170211 · Insight Dental System · DZE · Apr 27, 2017 · Dental

Device Facts

• Record ID: K170211
• Device Name: Insight Dental System
• Applicant: Insight Dental System
• Product Code: DZE · Dental
• Decision Date: Apr 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Insight Dental Implant System is intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The Insight Dental Implant System is intended for delayed loading.

Device Story

Insight Dental Implant System comprises endosseous root-form dental implants, abutments, and healing caps; used by dentists for prosthetic support in partially or fully edentulous patients. Implants feature titanium construction with blasted threaded surfaces; available in bone-level and tissue-level configurations with straight or tapered bodies. System includes internal connection and antirotation features; utilizes platform switching or standard collars. Components are provided in sterile, single-use kits. Dentist performs surgical implantation into mandible or maxilla; delayed loading protocol followed. System provides artificial root structure for single tooth replacement or fixed bridgework; enables screw-retained restorations. Benefits include restoration of dental function and aesthetics for patients.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing: dynamic fatigue testing per ISO 14801-2007, surface evaluation via SEM and X-ray/Auger electron spectroscopy, cytotoxicity testing per ISO 10993-5, and shelf-life validation via accelerated aging (ASTM F1980-07). Sterilization validated per ISO 11137-1/2.

Technological Characteristics

Materials: Ti-6AL-4V-ELI titanium (implants, abutments, healing caps), stainless steel (accessories). Design: Root-form, screw-type, internal connection, antirotation feature. Dimensions: 3.5-5.4mm diameter, 8.0-12.0mm length. Sterilization: Gamma irradiation (min 25 kGy, SAL 10^-6). Packaging: Tyvek lidded blister tray. Standards: ISO 14801 (fatigue), ISO 10993-5 (cytotoxicity), ASTM F1980-07 (shelf life), ISO 11137 (sterilization).

Indications for Use

Indicated for partially or fully edentulous patients requiring single tooth replacement, fixed bridgework, or dental retention in the mandible or maxilla. Intended for delayed 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

• BioHorizons Tapered Internal Implants (K143022)

Reference Devices

• BioHorizons Laser-Lok 3.0 Implant System (K093321)
• BioHorizons Tapered Internal Implant System (K071638)

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

April 27, 2017

Insight Dental System c/o David Furr Regulatory Correspondent FDC Services 8708 Capehart Cove Austin, Texas 78733

Re: K170211

Trade/Device Name: Insight Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 31, 2017 Received: April 3, 2017

Dear David Furr:

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 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

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the quality systems (OS) 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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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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# Indications for Use

510(k) Number (if known) K170211

Device Name Insight Dental Implant System

The Insight Dental Implant System is intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. The Insight Dental Implant System is intended for delayed loading.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary Pursuant to 21 CFR 807.92

Date: April 17, 2017 K170211

| 1. | Submitted By: | Insight Dental System<br>4766 Research Drive<br>San Antonio, Texas 78240<br>888-255-7935 |
|----|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | David C. Furr<br>FDC Services, LLC<br>8708 Capehart Cove<br>Austin, Texas 78733<br>512-906-9654 |
| 3. | Product: | Insight Dental Implant System<br>Regulation:<br>21CFR§872.3640 Class II<br>Product Codes:<br>DZE Implant, Endosseous, Root Form<br>NHA Abutment, Implant, Dental, Endosseous |
| 4. | Trade Name:<br>Common Name:<br>Regulation Name: | Insight Dental Implant System<br>Dental Implant & Abutment System<br>Endosseous Dental Implant |
| 5. | Primary Predicate: | BioHorizons Tapered Internal Implants K143022 |
| 6. | Reference Predicates: | BioHorizons Laser-Lok 3.0 Implant System K093321<br>BioHorizons Tapered Internal Implant System K071638 |

# Description:

The Insight Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully endetulous patients. The Insight Dental Implant System consists of one-stage and two-stage root form dental implants and abutments, which provide the dentist with screw retained restoration options. The devices covered by this submission are implants, abutments, and healing caps.

Implants are manufactured from titanium and feature a blasted finish on the threaded screw surface. The implants are provided in bone level and tissue level. The diameters of the implant fixtures are 3.5mm, 3.8mm, 4.6mm and 5.4mm; the lengths are 8.0mm, 10.0mm, and 12.0mm and is defined as the threaded implanted portion of the implant.

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#### 510(k) Premarket Notification Insight Dental Implant System

Abutments are available in both standard and angled configurations. Abutments are manufactured from titanium. Standard abutments are straight, 4.6mm in diameter and sized for every implant diameter including 3.5mm, 4.6mm and 5.4mm. Angled abutments are 17°, 4.9mm in diameter and sized for every implant diameter including 3.5mm, 3.8mm, 4.6mm and 5.4mm.

Healing caps are manufactured from titanium. The diameter of each healing cap matches an implant at 3.5mm, 3.8mm, 4.6mm and 5.4mm. Healing caps are straight.

The dental implants provided consist of a straight wall or tapered body type with a basic screw-type design in various platform options and feature an internal connection and antirotation feature. Insight Dental Implant System is available with either prevail platform switching feature or standard collar.

The Insight Dental System is packaged in a two section sterile tray with all of the implants and instruments needed for a single procedure included. All components of the system are intended for single use only.

## Indications for Use:

The Insight Dental Implant System is intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The Insight Dental Implant System is intended for delayed loading.

### Substantial Equivalence/Technological Characteristics:

The subject device is substantially equivalent to the BioHorizons Tapered Internal Implant System which is based on BioHorizons premarket notification (K143022). BioHorizon premarket notifications K071638 and K093321 were also used as reference predicate devices.

The subject device and the predicate devices have a similar intended use, design, technological characteristics, principals of operation, and are made of the same materials. The subject device and predicate devices encompass a similar range of physical dimensions, including diameter and length of the implants and diameter, height, and angle of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using irradiation. Any differences do not raise new issues of substantial equivalence.

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### 510(k) Premarket Notification Insight Dental Implant System

| Element of<br>Comparison | 510(k) Device:<br>Insight Dental System | Primary Predicate Device:<br>BioHorizons Tapered Internal<br>Implant System K143022 | Reference Device:<br>BioHorizons Laser-Lok 3.0<br>Implant System K093321 | Reference Device:<br>BioHorizons Tapered<br>Internal Implant System<br>K071638 | Explanation of<br>Differences |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation and<br>Product<br>Classification<br>Code | 21 CFR 872.3640<br>DZE<br>NHA | 21 CFR 872.3640<br>DZE<br>21 CFR 872.3630<br>NHA | 21 CFR 872.3640<br>DZE<br>21 CFR 872.3630<br>NHA | 21 CFR 872.3640<br>DZE<br>21 CFR 872.3630<br>NHA | None |
| Indications for Use | The Insight Dental Implant<br>System is intended for use in<br>the mandible or maxilla as an<br>artificial root structure for<br>single tooth replacement or<br>for fixed bridgework and<br>dental retention. The Insight<br>Dental Implant System is<br>intended for delayed loading. | The BioHorizons<br>Tapered Internal Implant<br>System is intended for use in<br>the mandible or maxilla as an<br>artificial root structure for<br>single tooth replacement or for<br>fixed bridgework and dental<br>retention. The BioHorizons<br>Tapered Implant System may<br>be restored immediately (1)<br>with a temporary prosthesis<br>that is not in functional<br>occlusion or (2) when splinted<br>together for multiple<br>tooth replacement or when<br>stabilized with an overdenture<br>supported by multiple<br>implants. | The BioHorizons<br>Tapered Internal Implant<br>System is intended for use in<br>the mandible or maxilla as an<br>artificial root structure for<br>single tooth replacement or<br>for fixed bridgework and<br>dental retention. The<br>BioHorizons Tapered Implant<br>System may be restored<br>immediately (1) with a<br>temporary prosthesis that is<br>not in functional occlusion or<br>(2) when splinted together for<br>multiple<br>tooth replacement or when<br>stabilized with an overdenture<br>supported by multiple<br>implants. | The BioHorizons<br>Tapered Internal Implant<br>System is intended for use in<br>the mandible or maxilla as<br>an artificial root structure for<br>single tooth replacement or<br>for fixed bridgework and<br>dental retention. The<br>BioHorizons Tapered<br>Implant System may be<br>restored immediately (1)<br>with a temporary prosthesis<br>that is not in functional<br>occlusion or (2) when<br>splinted together for multiple<br>tooth replacement or when<br>stabilized with an<br>overdenture supported by<br>multiple implants. | The IDS device is<br>intended for<br>delayed loading but<br>differences are not<br>significant when<br>used. |
| Principal Material<br>Formulation of<br>Implants | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Identical |
| Implant Shape,<br>Diameters and<br>Length | Tapered Shape<br>3.5, 3.8, 4.6, 5.4mm diameters<br>8.0, 10.0, 12.0 mm implanted<br>Lengths | Tapered Shape<br>3.0, 3.5, 4.5mm diameters<br>9.0, 10.5, 12.0, 15, 18mm<br>Lengths | Parallel wall with 2.5mm<br>apical taper<br>3.0mm diameter<br>10.5, 12.0, 15mm Lengths | Tapered Shape<br>3.5, 4.5, 5.7mm diameters<br>7.5, 9.0, 10.5, 12.0, 15mm<br>Lengths | BioHorizons has a<br>slightly smaller and<br>larger size, but<br>subject device is<br>bracketed within the<br>limits of the<br>predicate. No<br>significant<br>differences. |
| Element of<br>Comparison | 510(k) Device:<br>Insight Dental System | Primary Predicate Device:<br>BioHorizons Tapered Internal<br>Implant System K143022 | Reference Device:<br>BioHorizons Laser-Lok 3.0<br>Implant System K093321 | Reference Device:<br>BioHorizons Tapered<br>Internal Implant System<br>K071638 | Explanation of<br>Differences |
| Abutments | Abutment diameters<br>3.5, 3.8, 4.6, 5.4mm | N/A (references to K093321) | Abutment diameters<br>3.5, 3.8, 4.2, 4.5, 4.7, 5.5, 5.8,<br>5.9, 6.6, 6.8mm | N/A | BioHorizons has<br>slightly different<br>and larger sizes, but<br>subject device is<br>bracketed within the<br>limits of the<br>predicate. No<br>significant<br>differences. |
| Principal Material<br>Formulation of<br>Abutments | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Identical |
| Healing caps | Healing cap diameters<br>3.5, 3.8, 4.6 and 5.4mm | N/A (references to K093321) | Healing cap diameters<br>3, 3.5, 4.5, 5.7mm | N/A | BioHorizons has<br>slightly different<br>and larger sizes, but<br>subject device is<br>bracketed within the<br>limits of the<br>predicate. No<br>significant<br>differences. |
| Principal Material<br>Formulation of<br>Healing caps | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Identical |
| Principal Material<br>Formulation of<br>Class I Accessories | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel | No significant<br>differences |
| Packaging | Tyvek Lidded Blister Tray | Tyvek Lidded Blister Tray | Tyvek Lidded Blister Tray | Tyvek Lidded Blister Tray | No significant<br>differences |
| Sterility | Single Use Gamma Sterilized | Single Use Gamma Sterilized | Single Use Gamma Sterilized | Single Use Gamma Sterilized | Identical |

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### 510(k) Premarket Notification Insight Dental Implant System

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# Summary of Testing

The technological characteristics of the Insight Dental Implant System have been verified to be essentially the same as the predicate devices based on assessments of material composition, dimensional features, mechanical properties and biocompatibility of the implant and instrument materials. Comparative Dynamic Fatigue testing was performed to show equivalence to the predicate device. This testing was performed according to ISO-14801-2007, Dynamic fatigue test for endosseous dental implants for both bone level and tissue level implants.

Surface treatment was evaluated using SEM images, X-ray spectroscopy and auger electron spectroscopy of titanium surfaces.

Cytotoxicity testing according to ISO 10993-5 was also done on the implants materials to demonstrate that the manufacturing process did not change the biocompatibility profile. No additional biocompatibility testing was deemed necessary since the devices are constructed from medical quality titanium.

Shelf life testing has been conducted by accelerated aging according to ASTMF1980-07 and a 1 year shelf life has been established. Shelf life testing included visual inspection, seal strength and bubble testing.

Insight Dental Implant kits are sterilized by gamma irradiation was done to IS01137-1. The Sterility Assurance Level (SAL) for the product sterilization process is 10 . Dosage is a minimum of 25 kGy exposure. Validation was done using the VDmax 25 method (ISO 11137-2). Devices are not labeled as non-pyrogenic.

No clinical test data was used to support the decision of substantial equivalence.

# Conclusion:

In accordance with the Federal Food. Drug and Cosmetic Act. 21 CFR Part 807, and based on the information provided in this premarket notifications the Insight Dental Implant System is substantially equivalent to predicate devices as described herein.