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FDA 510(k)

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

K-Number: K041136 · 2004-10-22

ApplicantBio-Lok Intl., Inc.
Decision Date2004-10-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS 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 2004-10-22 under 510(k) number K041136. 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 MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS?

MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS is a medical device that received FDA 510(k) clearance on 2004-10-22. The listed applicant is Bio-Lok Intl., Inc.. The 510(k) number is K041136.

When did MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS receive FDA 510(k) clearance?

MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS received FDA 510(k) clearance on 2004-10-22, under 510(k) number K041136.

Who is the listed applicant for MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS?

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

The FDA product code for MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS 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 - TRK032454SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)

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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