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FDA 510(k)

ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM

K-Number: K132258 · 2013-11-19

ApplicantZimmer Dental, Inc.
Decision Date2013-11-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM 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 2013-11-19 under 510(k) number K132258. 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 ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM?

ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-19. The listed applicant is Zimmer Dental, Inc.. The 510(k) number is K132258.

When did ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM receive FDA 510(k) clearance?

ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM received FDA 510(k) clearance on 2013-11-19, under 510(k) number K132258.

Who is the listed applicant for ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM?

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 ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM?

The FDA product code for ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM 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 SystemsK120873ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEMK121709ZFX DENTAL CAD SYSTEMK113753ZIMMER DENTAL TAPERED SCREW-VENT XK113092ZIMMER CONTOUR PROVISIONAL COPINGK112160TAPERED SCREW-VENT X 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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