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FDA 510(k)

IMZ - DENTAL IMPLANT COMPONENTS

K-Number: K951615 · 1995-07-26

ApplicantImz, GmbH
Decision Date1995-07-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMZ - DENTAL IMPLANT COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Imz, GmbH. It received FDA 510(k) clearance on 1995-07-26 under 510(k) number K951615. 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 IMZ - DENTAL IMPLANT COMPONENTS?

IMZ - DENTAL IMPLANT COMPONENTS is a medical device that received FDA 510(k) clearance on 1995-07-26. The listed applicant is Imz, GmbH. The 510(k) number is K951615.

When did IMZ - DENTAL IMPLANT COMPONENTS receive FDA 510(k) clearance?

IMZ - DENTAL IMPLANT COMPONENTS received FDA 510(k) clearance on 1995-07-26, under 510(k) number K951615.

Who is the listed applicant for IMZ - DENTAL IMPLANT COMPONENTS?

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

What is the FDA product code for IMZ - DENTAL IMPLANT COMPONENTS?

The FDA product code for IMZ - DENTAL IMPLANT COMPONENTS is DZE.

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Other records listing Imz, GmbH 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.

K963520IMZ TWIN PLUS SCREWK963521IMZ TWIN PLUS - CYLINDERK963495IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEMK963522IMZ 2000 INTERLOCK 12/3 - SCREWK951609IMZ - DENTAL IMPLANT SURGICAL TRAYK951611IMZ - DENTAL IMPLANT SINGLE TOOTH ATTACHMENT

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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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