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FDA 510(k)

BRINK PRE-MAXILLARY IMPLANT

K-Number: K921580 · 1992-05-06

ApplicantImplantech Associates, Inc.
Decision Date1992-05-06
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BRINK PRE-MAXILLARY IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Implantech Associates, Inc.. It received FDA 510(k) clearance on 1992-05-06 under 510(k) number K921580. 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 BRINK PRE-MAXILLARY IMPLANT?

BRINK PRE-MAXILLARY IMPLANT is a medical device that received FDA 510(k) clearance on 1992-05-06. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K921580.

When did BRINK PRE-MAXILLARY IMPLANT receive FDA 510(k) clearance?

BRINK PRE-MAXILLARY IMPLANT received FDA 510(k) clearance on 1992-05-06, under 510(k) number K921580.

Who is the listed applicant for BRINK PRE-MAXILLARY IMPLANT?

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

What is the FDA product code for BRINK PRE-MAXILLARY IMPLANT?

The FDA product code for BRINK PRE-MAXILLARY IMPLANT is FZE.

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Other records listing Implantech Associates, 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.

K200610Customized Contour ImplantK191130Customized Contour ImplantK172389ePTFE-Coated Auricular ImplantK071470IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXXK052504GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-XK052505CALF IMPLANT, MODEL EC17-X

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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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