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FDA 510(k)

SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT

K-Number: K013227 · 2001-11-19

ApplicantSulzer Dental, Inc.
Decision Date2001-11-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT 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 2001-11-19 under 510(k) number K013227. 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 SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT?

SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT is a medical device that received FDA 510(k) clearance on 2001-11-19. The listed applicant is Sulzer Dental, Inc.. The 510(k) number is K013227.

When did SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT receive FDA 510(k) clearance?

SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT received FDA 510(k) clearance on 2001-11-19, under 510(k) number K013227.

Who is the listed applicant for SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT?

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 SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT?

The FDA product code for SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT 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 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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