SPECTRA SYSTEM DENTAL IMPLANTS 2008

K090234 · Implant Direct, LLC · DZE · May 15, 2009 · Dental

Device Facts

• Record ID: K090234
• Device Name: SPECTRA SYSTEM DENTAL IMPLANTS 2008
• Applicant: Implant Direct, LLC
• Product Code: DZE · Dental
• Decision Date: May 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The Dental Implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of single-tooth or multiple-tooth restorations, recognizing bone stability and appropriate occusal load requirements.

Device Story

Spectra-System Dental Implants 2008 comprise a two-piece system including fixtures, abutments, healing components, and screws. Used by dental professionals in clinical settings for mandible and maxilla reconstruction. Supports single or multiple-tooth restorations (cement or screw-retained) and overdentures. Enables immediate placement and function when bone stability and occlusal load criteria are met. System integrates into standard dental surgical workflows to restore patient dentition and improve oral function.

Clinical Evidence

No clinical data. Substantial equivalence is based on physical, material, and manufacturing comparisons to previously cleared predicate devices.

Technological Characteristics

Two-piece endosseous dental implant system consisting of fixtures, abutments, healing components, and screws. Materials and manufacturing methods are consistent with previously approved predicate devices.

Indications for Use

Indicated for patients requiring dental restoration in the mandible or maxilla. Supports single or multiple unit cement/screw-retained restorations and overdentures. Suitable for immediate placement and function, contingent on bone stability and occlusal load requirements.

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

• Implant Direct LLC Spectra-System (K061319)
• Implant Direct LLC ReActive Dental Implant System (K080713)
• Implant Direct LLC Legacy Implants With HA Coating (K073033)

Submission Summary (Full Text)

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simply smarter

090237

Spectra-System Dental Im

Spectra-System Dental Implants 2008 Traditional 510(K) Submission

# 510(K) Summary (21CFR 807.92(a))

- 1. Submitter's Information Company Name: Implant Direct LLC Address: 27030 Malibu Hills Rd., Calabasas Hills, CA USA 91301 Telephone Number: 818-444-3300 Fax Number: 818-444-3400 Registration Number: 3001617766 Contact Person: Tom Gottenbos Date Summary Prepared: October 13, 2008 Classification Name: Implant, Dental, Endosseous Common/Usual Name: Endosseous Dental Implant
MAY 15 2003

2. Device Trade Name: Spectra-System Dental Implants 2008

- Predicate Device(s): Implant Direct LLC Spectra-System (K061319), Implant 3. Direct LLC ReActive Dental Implant System (K080713), Implant Direct LLC Legacy Implants With HA Coating (K073033)
### Device Description: র্ব.

The Spectra-System Dental Implants 2008 system consists of implants, abutments, healing components, and screws for use in one or two-stage placement and restorations.

#### 5. Intended Use:

The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The Dental Implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of single-tooth or multiple-tooth restorations, recognizing bone stability and appropriate occusal load requirements.

#### હ. Device Comparison:

This submission is comprised of devices whose physical dimensions, material composition, indications for use and methods of manufacture were previously approved and have the same principles of operation as the cited predicate devices. The differences between the components included in this submission and their predicate devise pose no new or additional issues of safety or effectiveness.

7 030 Malibu Hills Road Calabasas Hills CA USA 9 130 1 - 8 18 . 4 4 . 3 3 17

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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### Public Health Service

MAY 15 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas Gottenbos VP of IT/Regulatory Affairs Implant Direct LLC 27030 Malibu Hills Road Calabasas Hills, California 91301

Re: K090234

Trade/Device Name: Spectra-System Dental Implants 2008 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 11, 2009 Received: May 13, 2009

Dear Mr. Gottenbos:

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.

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

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Page 2- Mr. Gottenbos

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Punner

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K090234

# Indications for Use

510(k) Number (if known): _ Kø 90234

Device Name: Spectra-System Dental Implants 2008

Indications for Use:

Spectra-System Dental Implants 2008 are comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of singletooth or multiple-tooth restorations, recognizing bone stability and appropriate occusal load requirements.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muliy for MSR

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(Division Sign-Off) (Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K090234

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