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DEPARTMENT OFBHEALTH &HUMLANSERVICES Public Health Service

7,111 ~ ~~~~~~~~~~~~~~~~~~~Food and Drug Administration9200 Corporate BoulevardRockville MD 20850

SEP 2 6 2006

Ms. Patty McMahonVice PresidentImplant Direct, LLC27030 Malibu Hills RoadCalabasas Hills, California 91301

Re: K061319Trade/Device Namne: Spectra Dental Implant SystemRegulation Number: 872.3640Rcgulation Name: Endosseous Dental ImplantRegulatory Class: ILProduct Code: DZEDated: July 28, 2006Received: July 31, 2006

Dear Ms. McMahon:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for theindications for use stated in the enclosure) to legally marketed predicate devices marketed ininterstate commerce prior to May 28, 1976, the enactment date of the Medical DeviceAmendments, or to devices that have been reclassified in accordance with the provisions ofthe Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a prcmnarketapproval application (PMA). You may, therefore, market the device, sub~ject to the generalcontrols provisions of the Act. The general controls provisions ofthe;Act includerequirements 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 1I (Special Controls) or class IIl(IPMA), it may be subject to such additional controls. lixisting major regulations affectingyour device can be fbund in the Code of Federal Regulations, Title 2 1. larts 800 to 898. Inaddition, FDA may publish further announcements concerning your device in the FederalRci~ster.

Page 2 - Ms. McMahon

Please be advised that FDA's issuance of a substantial equivalence determination does notmean that FDA has made a determination that your device complies with other requirementsof 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: registrationand listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practicerequirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and ifapplicable, the electronic product radiation control provizions (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 alegally marketed predicate device results in a classification for your device and thus, permitsyour 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 Office of Compliance at (240) 276-0115. Also, please note the regulationentitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Youmay obtain other general information on your responsibilities under the Act fi-om theDivision of Small Manufacturers, International and Consumer Assistance at its toll-fieenumber (800) 638-2041 or (301) 443-6597 or at its Internet addresshttp://www.fda.gov/cdrh/industry/support/index.htrnl.

Sincerely yours,

Ch0iu Lin, Ph.i D.DirectorDivision of Anesthesiology, General Hospital,

Infection Control and Dental DevicesOffice of Device EvaluationCenter for Devices and

Radiological Health

Enclosure

Indications for Use

510(k) Number (if known): K061319

Device Name: Spectra Dental Implant System

Indications for Use:

The Spectra Dental Implant System consists of one-piece or two-piece implants for single-stage or two-stage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae,in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixedbridgework. They may be placed in immediate function if initial implant stability can be established.

The ScrewDirect 3.0rmm implant is indicated for:

1. An artificial root structure for single tooth replacement of mandibular central and lateral incisorsand maxillary lateral incisors.

2. Multiple tooth replacements or denture stabilization.

The Screw Redirect implant is intended for support and retention of fixed single tooth and fixedpartial denture restorations in the premolar, cuspid, and incisor regions of the partiallyedentulous maxillary jaw. It is indicated for immediate functional loading when four or moreimplants are splinted together in the endentulous upper or lower jaw.

The Screw Indirect implant is indicated for the support and retention of bar overdentures or as aterminal or intermediary attachment for screw-retained fixed bridgework. It is indicated forimmediate functional loading when four or more implants are splinted together in the edentulousupper or lower jaw. This implant model is not indicated for use with abutments, only with a 2mmextender.

Prescription Use A / Over-The-Counter Use(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

21 Anesttiestotogy, Generral Ilosp ,*..sn Control, Dental Devicea

<imnber: <0 '§3/