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FDA 510(k)

ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13

K-Number: K071235 · 2007-05-30

ApplicantZimmer Dental, Inc.
Decision Date2007-05-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 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 2007-05-30 under 510(k) number K071235. 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 ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13?

ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 is a medical device that received FDA 510(k) clearance on 2007-05-30. The listed applicant is Zimmer Dental, Inc.. The 510(k) number is K071235.

When did ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 receive FDA 510(k) clearance?

ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 received FDA 510(k) clearance on 2007-05-30, under 510(k) number K071235.

Who is the listed applicant for ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13?

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 ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13?

The FDA product code for ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 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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