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FDA 510(k)

INTRA-LOCK OP DENTAL IMPLANT

K-Number: K130140 · 2013-08-01

ApplicantIntra-Lock International
Decision Date2013-08-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTRA-LOCK OP DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Intra-Lock International. It received FDA 510(k) clearance on 2013-08-01 under 510(k) number K130140. 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 INTRA-LOCK OP DENTAL IMPLANT?

INTRA-LOCK OP DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 2013-08-01. The listed applicant is Intra-Lock International. The 510(k) number is K130140.

When did INTRA-LOCK OP DENTAL IMPLANT receive FDA 510(k) clearance?

INTRA-LOCK OP DENTAL IMPLANT received FDA 510(k) clearance on 2013-08-01, under 510(k) number K130140.

Who is the listed applicant for INTRA-LOCK OP DENTAL IMPLANT?

The FDA 510(k) record lists Intra-Lock International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRA-LOCK OP DENTAL IMPLANT?

The FDA product code for INTRA-LOCK OP DENTAL IMPLANT is DZE.

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Other records listing Intra-Lock International 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.

K080598MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICSK070601MINI DRIVE-LOCK DENTAL IMPLANT SYSTEMK050970MILO DENTAL IMPLANT SYSTEMK040205INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTSK031322INTRA-LOCK HYDROXYAPATITE COATED IMPLANTSK021915TRANSITIONAL IMPLANTS

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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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