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FDA 510(k)

IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM

K-Number: K963495 · 1997-03-03

ApplicantImz, GmbH
Decision Date1997-03-03
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Imz, GmbH. It received FDA 510(k) clearance on 1997-03-03 under 510(k) number K963495. 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 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM?

IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-03. The listed applicant is Imz, GmbH. The 510(k) number is K963495.

When did IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 1997-03-03, under 510(k) number K963495.

Who is the listed applicant for IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM?

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 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM?

The FDA product code for IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM 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 - CYLINDERK963522IMZ 2000 INTERLOCK 12/3 - SCREWK951609IMZ - DENTAL IMPLANT SURGICAL TRAYK951611IMZ - DENTAL IMPLANT SINGLE TOOTH ATTACHMENTK951614IMZ - DENTAL 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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