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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K061319
Device Name SPECTRA SYSTEM
Applicant
Implant Direct, LLC
27030 Malibu Hills Rd.
Calabasas,  CA  91301
Applicant Contact LESLIE TERRY
Correspondent
Implant Direct, LLC
27030 Malibu Hills Rd.
Calabasas,  CA  91301
Correspondent Contact LESLIE TERRY
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/11/2006
Decision Date 09/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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