SPECTRA-SYSTEM ABUTMENTS 2008

K081101 · Implant Direct, LLC · NHA · Jan 14, 2009 · Dental

Device Facts

• Record ID: K081101
• Device Name: SPECTRA-SYSTEM ABUTMENTS 2008
• Applicant: Implant Direct, LLC
• Product Code: NHA · Dental
• Decision Date: Jan 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The intended uses of the Spectra-System Abutments are identical to the intended use of the predicate implants. The included abutments are accessories to endosseous dental implants designed to support a prosthesis in the partially or fully endentulous mandible or maxilla. The laboratory components in this submission are used in a dental laboratory to aid in the fabrication of a final prosthetic appliance.

Device Story

Spectra-System Abutments 2008 are dental implant accessories used to support prosthetic restorations. The system includes various configurations: non-engaging titanium temporary abutments, angled screw-receiving abutments, narrow series abutments, and non-engaging plastic or gold abutments. These components are used by dental professionals in clinical settings or dental laboratories to facilitate the fabrication and attachment of final dental prostheses (crowns, bridges, overdentures) to endosseous dental implants. The abutments provide the interface between the implant and the prosthetic appliance, which may be screw or cement-retained. By providing a stable connection, the device enables the restoration of function and aesthetics for edentulous patients.

Clinical Evidence

No clinical data. Substantial equivalence is based on physical, material, and design comparisons to legally marketed predicate devices.

Technological Characteristics

Components include titanium, plastic, and gold abutments. The system functions as an interface for endosseous dental implants. No software, energy source, or active sensing components are involved. Sterilization and specific material standards are not detailed in the provided text.

Indications for Use

Indicated for use in partially or completely edentulous patients requiring support for prosthetic restorations (crowns, bridges, overdentures, or custom fabrications) in the mandible or maxilla, attached to dental implants via screw or cement retention.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• Implant Direct Spectra-System Dental Implant System (K061319)
• Sulzer Dental Screw-Vent Dental Implant System Custom Cast Abutments (K011028)
• Nobel Replace Tapered Groovy Custom Cast Abutments (K050258)
• Nobel Replace Tapered Groovy Multi Unit Abutments (K050258)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a logo for Implant Direct LLC. The logo features a large letter "D" with a screw design on the left side. To the right of the "D" is the text "Implant Direct LLC" in a bold, sans-serif font. Below the "D" is the website address "www.implantdirect.com".

JAN 1 4 2009

Spectra-System Abutments 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: March 13, 2008 Classification Name: Abutment, Implant, Dental, Endosseous Common/Usual Name: Endosseous Dental Implant Abutment

2. Device Trade Name: Spectra-System Abutments 2008

- Predicate Device(s): Implant Direct Spectra-System Dental Implant System 3. (K061319), Sulzer Dental Screw-Vent Dental Implant System Custom Cast Abutments (K011028), Nobel Replace Tapered Groovy Custom Cast Abutments (K050258), Nobel Replace Tapered Groovy Multi Unit Abutments (K050258)
#### 4. Device Description:

Spectra-System Abutments 2008 consist of a number abutment used in conjunction with dental implants for provisional, permanent or laboratory fabrication of a final dental prosthesis. The system includes Non-Engaging Titanium Temporary Abutments, Angled Screw-Receiving Abutments, Narrow ("N" Series) Abutments, Non-Engaging Plastic Abutments, Non-Engaging Gold Abutments and related components.

#### 5. Intended Use:

The intended uses of the Spectra-System Abutments are identical to the intended use of the predicate implants. The included abutments are accessories to endosseous dental implants designed to support a prosthesis in the partially or fully endentulous mandible or maxilla. The laboratory components in this submission are used in a dental laboratory to aid in the fabrication of a final prosthetic appliance.

#### 6. Device Comparison:

This submission is comprised of abutments 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.

7030Malibu Hills Road CalabasasHills CA USA91301 -818.444.3317

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features an eagle with its wings spread, clutching a staff with a snake wrapped around it, which is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas Gottenbos Vice President of IT / Regulatory Affairs Implant Direct L.L.C. 27030 Malibu Hills Road Calabasas Hills, California 91301

JAN 1 4 2009

Re: K081101

Trade/Device Name: Spectra-System Abutments 2008 Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 22, 2008 Received: December 29, 2008

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 such 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. Gottenbos

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 Runnes
Chiu Lin, Ph.D.

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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# Indications for Use

510(k) Number (if known): Ko 8 110 (

Device Name: Spectra-System Abutments 2008

Indications for Use:

Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandible or maxilla. Prostheses can be screw or cement retained to the abutment.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumer

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

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510(k) Number: Kas 1101.