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FDA 510(k)

TAPER-LOCK DENTAL IMPLANT SYSTEM

K-Number: K011038 · 2001-05-15

ApplicantSulzer Dental, Inc.
Decision Date2001-05-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TAPER-LOCK DENTAL IMPLANT SYSTEM 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 2001-05-15 under 510(k) number K011038. 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 TAPER-LOCK DENTAL IMPLANT SYSTEM?

TAPER-LOCK DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-15. The listed applicant is Sulzer Dental, Inc.. The 510(k) number is K011038.

When did TAPER-LOCK DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

TAPER-LOCK DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2001-05-15, under 510(k) number K011038.

Who is the listed applicant for TAPER-LOCK DENTAL IMPLANT SYSTEM?

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 TAPER-LOCK DENTAL IMPLANT SYSTEM?

The FDA product code for TAPER-LOCK DENTAL IMPLANT SYSTEM is DZE.

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Other records listing Sulzer Dental, 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.

K014050HEX-LOCK TEMPORARY ABUTMENTK014175SULZER DENTAL CERAMIC SYSTEM-HEXLOCKK014214SULZER DENTAL CERAMIC SYSTEM-SPLINEK0134943.75MM AND 5.0MM SPLINE TWIST IMPLANTK013227SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANTK0120553.25MM SPLINE TWIST IMPLANT

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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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