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FDA 510(k)

SPECTRA SYSTEM

K-Number: K061319 · 2006-09-29

ApplicantImplant Direct, LLC
Decision Date2006-09-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPECTRA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct, LLC. It received FDA 510(k) clearance on 2006-09-29 under 510(k) number K061319. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRA SYSTEM?

SPECTRA SYSTEM is a medical device that received FDA 510(k) clearance on 2006-09-29. The listed applicant is Implant Direct, LLC. The 510(k) number is K061319.

When did SPECTRA SYSTEM receive FDA 510(k) clearance?

SPECTRA SYSTEM received FDA 510(k) clearance on 2006-09-29, under 510(k) number K061319.

Who is the listed applicant for SPECTRA SYSTEM?

The FDA 510(k) record lists Implant Direct, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRA SYSTEM?

The FDA product code for SPECTRA SYSTEM is DZE.

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Other records listing Implant Direct, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090234SPECTRA SYSTEM DENTAL IMPLANTS 2008K081101SPECTRA-SYSTEM ABUTMENTS 2008K081396SWISSPLANT DENTAL IMPLANT SYSTEMK080633SCREWINDIRECT DENTAL IMPLANTSK080713REACTIVE DENTAL IMPLANT SYSTEMK073161REPLUS DENTAL IMPLANTS (HA)

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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