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FDA 510(k)

HEX-LOCK TEMPORARY ABUTMENT

K-Number: K014050 · 2002-11-13

ApplicantSulzer Dental, Inc.
Decision Date2002-11-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HEX-LOCK TEMPORARY ABUTMENT is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Dental, Inc.. It received FDA 510(k) clearance on 2002-11-13 under 510(k) number K014050. 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 HEX-LOCK TEMPORARY ABUTMENT?

HEX-LOCK TEMPORARY ABUTMENT is a medical device that received FDA 510(k) clearance on 2002-11-13. The listed applicant is Sulzer Dental, Inc.. The 510(k) number is K014050.

When did HEX-LOCK TEMPORARY ABUTMENT receive FDA 510(k) clearance?

HEX-LOCK TEMPORARY ABUTMENT received FDA 510(k) clearance on 2002-11-13, under 510(k) number K014050.

Who is the listed applicant for HEX-LOCK TEMPORARY ABUTMENT?

The FDA 510(k) record lists Sulzer Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEX-LOCK TEMPORARY ABUTMENT?

The FDA product code for HEX-LOCK TEMPORARY ABUTMENT is DZE.

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Other records listing Sulzer Dental, Inc. as applicant

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K014175SULZER DENTAL CERAMIC SYSTEM-HEXLOCKK014214SULZER DENTAL CERAMIC SYSTEM-SPLINEK0134943.75MM AND 5.0MM SPLINE TWIST IMPLANTK013227SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANTK0120553.25MM SPLINE TWIST IMPLANTK011245ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM

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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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