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FDA 510(k)

INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS

K-Number: K031322 · 2003-12-23

ApplicantIntra-Lock International
Decision Date2003-12-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS 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 2003-12-23 under 510(k) number K031322. 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 HYDROXYAPATITE COATED IMPLANTS?

INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS is a medical device that received FDA 510(k) clearance on 2003-12-23. The listed applicant is Intra-Lock International. The 510(k) number is K031322.

When did INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS receive FDA 510(k) clearance?

INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS received FDA 510(k) clearance on 2003-12-23, under 510(k) number K031322.

Who is the listed applicant for INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS?

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 HYDROXYAPATITE COATED IMPLANTS?

The FDA product code for INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS 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.

K130140INTRA-LOCK OP DENTAL IMPLANTK080598MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICSK070601MINI DRIVE-LOCK DENTAL IMPLANT SYSTEMK050970MILO DENTAL IMPLANT SYSTEMK040205INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTSK021915TRANSITIONAL 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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