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FDA 510(k)

SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)

K-Number: K032454 · 2004-03-04

ApplicantBio-Lok Intl., Inc.
Decision Date2004-03-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Lok Intl., Inc.. It received FDA 510(k) clearance on 2004-03-04 under 510(k) number K032454. 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 SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)?

SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) is a medical device that received FDA 510(k) clearance on 2004-03-04. The listed applicant is Bio-Lok Intl., Inc.. The 510(k) number is K032454.

When did SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) receive FDA 510(k) clearance?

SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) received FDA 510(k) clearance on 2004-03-04, under 510(k) number K032454.

Who is the listed applicant for SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)?

The FDA 510(k) record lists Bio-Lok Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)?

The FDA product code for SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) is DZE.

Related Clinical Trials

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.

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Other records listing Bio-Lok Intl., Inc. 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.

K060285BONEGEN - TRK041136MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS

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

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

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