Neodent Implant System- CM Drive Implants

K150182 · Jjgc Industria E Comercio DE Materiais Dentarios S · DZE · Apr 23, 2015 · Dental

Device Facts

• Record ID: K150182
• Device Name: Neodent Implant System- CM Drive Implants
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S
• Product Code: DZE · Dental
• Decision Date: Apr 23, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Device Story

Neodent Implant System consists of threaded, self-tapping, root-form endosseous dental implants with Morse taper abutment interface. Implants are surgically placed in upper or lower jaw bone by dental professionals to support prosthetic teeth. System includes 18mm length implants, expanding existing range. Features include commercially pure titanium construction; acid-etched or hydrophilic Acqua surface finishes. Abutments include retention grooves for secure transfer tool engagement and modified pilot hole depth for increased wall thickness. Device used in clinical dental settings; provides stable foundation for prosthetic restoration; restores chewing function; improves patient quality of life.

Clinical Evidence

Bench testing only. Dynamic fatigue testing performed per ISO 14801 and FDA guidance for root-form endosseous dental implants. Worst-case scenario testing (angled prosthetic abutments) confirmed performance equivalence. FMEA conducted to validate sterility, packaging, and biocompatibility.

Technological Characteristics

Commercially pure titanium (ASTM F67). Morse taper implant-to-abutment connection. Precision machined one-piece construction. Available in 3.5, 4.3, 5.0 mm diameters and 18.0 mm length. Surface finishes: acid-etched or hydrophilic grit-blasted/acid-etched. Sterilization: Gamma irradiation (25 kGy min).

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw for support of prosthetic devices (artificial teeth) to restore chewing function. Suitable for single or multiple unit restorations using single-stage or two-stage surgical procedures; immediate loading permitted given sufficient 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

• Neodent Implant System (K123022) CM Drive Implants
• Neodent Implant System (K133592) Acqua Surface

Reference Devices

• Neodent Implant System (K101945) Titamax CM EX Implants
• Straumann Screw Retained Abutments (K141871)

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 23, 2015

JJGC Industria e Comercio de Materiais Dentarios SA c/o Mr. Christopher Klaczyk Instradent USA 60 Minuteman Road Andover, MA 01810

Re: K150182

Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 23, 2015 Received: March 24, 2015

Dear Mr. Klaczyk:

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 - Mr. Christopher Klaczyk

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,

Tina
Kiang-S

for 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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## Indications For Use

510(k) Number (if known): K150182

Neodent Implant System Device Name:

Indications for Use:

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Prescription Use____________ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## K150182

## 510(k) Summary

| Submitter: | Instradent USA, Inc. (on behalf of JJGC Indústria e Comércio<br>de Materiais Dentários SA)<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 3010593814<br>Owner/Operator No.: 10045493 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher Klaczyk<br>Acting Director of Regulatory Affairs<br>Tel.: [phone] |
| Date Prepared: | April 23, 2015 |
| Product Code(s): | DZE, NHA |
| Device Class: | II |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental implant (21 CFR 872.3640) |
| Proprietary Name: | Neodent Implant System |
| Predicate Device(s): | • Neodent Implant System (K123022) CM Drive Implants; Primary predicate<br>• Neodent Implant System (K133592) Acqua Surface |
| Reference Device(s): | • Neodent Implant System (K101945) Titamax CM EX Implants<br>• Straumann Screw Retained Abutments (K141871) |
| Device Description: | The subject Neodent Implant System implants are threaded, self-tapping, root form, endosseous dental implants with a Morse taper abutment interface. The proposed CM Drive implants come in three diameters (3.5, 4.3 and 5.0 mm) and a length of 18.0 mm. They are made of commercially pure |

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| | and acid etched surface finish or the Acqua grit blasted,<br>acid etched and hydrophilic, chemically active surface<br>finish. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The CM Drive implants (K123022) have been shown to be<br>compatible with the previously cleared angled abutments<br>(K101945) having the CM implant-to-abutment interface. |
| | The addition of the 18mm lengths to the previously cleared<br>CM Drive Implants has no detrimental impact on device<br>indications or performance. All other attributes are<br>identical. No modifications were made to the coronal<br>features of the implant that would impact dynamic fatigue<br>performance. |
| | A groove has been added to the conic portion of six (6) CM<br>Mini Conical Abutments to ensure that the abutments do not<br>release from the transfer tool during transfer from the package<br>until secured in the implant. This feature also assures secure<br>retention of the abutment in the package during storage and<br>shipment. |
| | The pilot hole depth of the CM Abutments was reduced in order<br>to increase the minimum wall thickness of the abutment. The<br>length of the internally threaded portion of the abutment was<br>not changed, so engagement between the occlusal screw and the<br>abutment is also unchanged. |
| Intended Use: | The Neodent Implant System is intended to be surgically placed<br>in the bone of the upper or lower jaw to provide support for<br>prosthetic devices such as artificial teeth, to restore chewing<br>function. It may be used with single-stage or two-stage<br>procedures, for single or multiple unit restorations, and may be<br>loaded immediately when good primary stability is achieved<br>and with appropriate occlusal loading. |
| Materials: | The subject devices are produced from commercially pure<br>titanium conforming to ASTM F67. This is the same material<br>as for the predicate devices cleared to market per premarket<br>notification submission K123022. |
| Technological<br>Characteristics: | The proposed Neodent Implant System – CM Drive Implants<br>are manufactured using precision machining systems from solid<br>material (i.e. one-piece construction). All technological<br>characteristics of the subject devices are the same as for the<br>predicate devices. |

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| Feature | Subject Devices<br>CM Drive Implants<br>K150182 | Predicate Devices<br>CM Drive Implants<br>K123022 & K133592 | Comparison<br>Summary |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Implant-to-Abutment<br>Connection | Morse Taper | Morse Taper | Same |
| Diameter(s) | 3.5, 4.3 & 5.0 mm | 3.5, 4.3 & 5.0 mm | Same |
| Length(s) | 18 mm | 8, 10, 11.5, 13 & 16 mm | Similar to reference device<br>K101945 |
| Material | Commercially pure titanium,<br>Grade 4 | Commercially pure titanium,<br>Grade 4 | Same |
| Primary Package | Styrene-butadiene copolymer<br>vial with a polystyrene and<br>thermoplastic elastomer cap<br>contained within a PET tray<br>and sealed with a Tyvek lid | Styrene-butadiene copolymer<br>vial with a polystyrene and<br>thermoplastic elastomer cap<br>contained within a PET tray<br>and sealed with a Tyvek lid | Same |
| Sterilization | Gamma irradiation, 25 kGy<br>min. | Gamma irradiation, 25 kGy<br>min. | Same |
| Dynamic Fatigue<br>Test Configuration | 30° Universal CM Exact<br>Abutment | No test data submitted -<br>limited to straight abutments | Similar to reference device<br>K101945 |

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| Performance Data: | Per Guidance for Industry and FDA Staff - Class II Special<br>Controls Guidance Document: Root-form Endosseous Dental<br>Implants and Endosseous Dental Abutments dated May 12,<br>2004, the substantial equivalence of the subject device(s) are<br>satisfactorily addressed via bench studies. Dynamic fatigue test<br>data consistent with FDA guidance and ISO 14801 have been<br>referenced in support of this submission. |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | The load-bearing features of the implant-abutment connection<br>were tested in conjunction with angled prosthetic abutments<br>representative of the worst-case scenario. The results of the<br>fatigue load testing demonstrate that the subject devices are<br>substantially equivalent to the predicate devices. |
| | |
| | A risk analysis in the form of a Failure Modes and Effect<br>Analysis was conducted to assess substantial equivalence of the<br>submission device with respect to the changes to the device and<br>labeling. FMEA demonstrated sterility, packaging, and<br>biocompatibility assessments for the predicate and reference<br>devices are also applicable to the subject devices. |
| Summary: | The primary modification of the subject device is addition of<br>an 18mm length for the device system CM Drive implants,<br>cleared in K123022 (primary predicate) and K133592. While<br>the subject CM Drive implants having 18 mm length exceed<br>the range of previously cleared lengths for predicate devices,<br>the previously cleared reference predicate Titamax CM EX<br>(K101945) series includes implants with length of 19mm. |
| Conclusions: | The subject device and the predicated devices have the same<br>intended use, have similar technological characteristics,<br>identical material composition and encompass a very similar<br>or the exact same range of physical dimensions, including<br>diameter and length of the implants and Implant to Abutment<br>connection and sterilization.Based upon our assessment of the<br>design and applicable performance data, the subject devices<br>have been determined to be substantially equivalent to the<br>identified predicate devices. |