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FDA 510(k)

IMZ TWIN PLUS SCREW

K-Number: K963520 · 1997-08-12

ApplicantImz, GmbH
Decision Date1997-08-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMZ TWIN PLUS SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Imz, GmbH. It received FDA 510(k) clearance on 1997-08-12 under 510(k) number K963520. 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 TWIN PLUS SCREW?

IMZ TWIN PLUS SCREW is a medical device that received FDA 510(k) clearance on 1997-08-12. The listed applicant is Imz, GmbH. The 510(k) number is K963520.

When did IMZ TWIN PLUS SCREW receive FDA 510(k) clearance?

IMZ TWIN PLUS SCREW received FDA 510(k) clearance on 1997-08-12, under 510(k) number K963520.

Who is the listed applicant for IMZ TWIN PLUS SCREW?

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 TWIN PLUS SCREW?

The FDA product code for IMZ TWIN PLUS SCREW 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.

K963521IMZ TWIN PLUS - CYLINDERK963522IMZ 2000 INTERLOCK 12/3 - SCREWK963495IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEMK951609IMZ - DENTAL IMPLANT SURGICAL TRAYK951611IMZ - DENTAL IMPLANT SINGLE TOOTH ATTACHMENTK951615IMZ - DENTAL IMPLANT COMPONENTS

View all 12 devices →

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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