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FDA 510(k)

CUI PREMAXILLARY IMPLANT

K-Number: K903328 · 1990-09-10

ApplicantCui Corp.
Decision Date1990-09-10
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUI PREMAXILLARY IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Cui Corp.. It received FDA 510(k) clearance on 1990-09-10 under 510(k) number K903328. The device is classified under product code FZE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUI PREMAXILLARY IMPLANT?

CUI PREMAXILLARY IMPLANT is a medical device that received FDA 510(k) clearance on 1990-09-10. The listed applicant is Cui Corp.. The 510(k) number is K903328.

When did CUI PREMAXILLARY IMPLANT receive FDA 510(k) clearance?

CUI PREMAXILLARY IMPLANT received FDA 510(k) clearance on 1990-09-10, under 510(k) number K903328.

Who is the listed applicant for CUI PREMAXILLARY IMPLANT?

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

What is the FDA product code for CUI PREMAXILLARY IMPLANT?

The FDA product code for CUI PREMAXILLARY IMPLANT is FZE.

Related Clinical Trials

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.

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Other records listing Cui Corp. 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.

K913140SILICONE GEL SHEETINGK904348CUI FEATHERED SILICONE MALARK904349CUI CURVILINEAR SILICONE CHINK904350CUI DORSAL COLUMELLA PROSTHESISK903329CUI ANATOMICAL SILICONE MALARK903327CUI ARTICULATED SILICONE CHIN

View all 7 devices →

Related Devices (Code: FZE)

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.

K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc.K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd.K090803HANSON MEDICAL FACIAL IMPLANTSHanson Medical, Inc.K090630NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)Nobel Biocare ABK071018MONARCH NASAL IMPLANTHanson Medical, Inc.K041690MONARCH NASAL IMPLANTHanson Medical, 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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