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FDA 510(k)

SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT

K-Number: K061410 · 2006-09-08

ApplicantZimmer Dental, Inc.
Decision Date2006-09-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Dental, Inc.. It received FDA 510(k) clearance on 2006-09-08 under 510(k) number K061410. 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 SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT?

SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT is a medical device that received FDA 510(k) clearance on 2006-09-08. The listed applicant is Zimmer Dental, Inc.. The 510(k) number is K061410.

When did SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT receive FDA 510(k) clearance?

SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT received FDA 510(k) clearance on 2006-09-08, under 510(k) number K061410.

Who is the listed applicant for SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT?

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

What is the FDA product code for SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT?

The FDA product code for SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT is DZE.

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Other records listing Zimmer 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.

K160398MRI Compatibility for Existing Zimmer Dental Implant SystemsK132258ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEMK120873ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEMK121709ZFX DENTAL CAD SYSTEMK113753ZIMMER DENTAL TAPERED SCREW-VENT XK113092ZIMMER CONTOUR PROVISIONAL COPING

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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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