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FDA 510(k)

TAPERED SCREW-VENT X IMPLANT

K-Number: K112160 · 2011-12-14

ApplicantZimmer Dental, Inc.
Decision Date2011-12-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TAPERED SCREW-VENT X 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 2011-12-14 under 510(k) number K112160. 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 TAPERED SCREW-VENT X IMPLANT?

TAPERED SCREW-VENT X IMPLANT is a medical device that received FDA 510(k) clearance on 2011-12-14. The listed applicant is Zimmer Dental, Inc.. The 510(k) number is K112160.

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

TAPERED SCREW-VENT X IMPLANT received FDA 510(k) clearance on 2011-12-14, under 510(k) number K112160.

Who is the listed applicant for TAPERED SCREW-VENT X 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 TAPERED SCREW-VENT X IMPLANT?

The FDA product code for TAPERED SCREW-VENT X 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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