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FDA 510(k)

BUD MAXILLOFACIAL IMPLANT SYSTEM

K-Number: K913688 · 1992-05-05

ApplicantBud Industries, Inc.
Decision Date1992-05-05
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BUD MAXILLOFACIAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bud Industries, Inc.. It received FDA 510(k) clearance on 1992-05-05 under 510(k) number K913688. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUD MAXILLOFACIAL IMPLANT SYSTEM?

BUD MAXILLOFACIAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1992-05-05. The listed applicant is Bud Industries, Inc.. The 510(k) number is K913688.

When did BUD MAXILLOFACIAL IMPLANT SYSTEM receive FDA 510(k) clearance?

BUD MAXILLOFACIAL IMPLANT SYSTEM received FDA 510(k) clearance on 1992-05-05, under 510(k) number K913688.

Who is the listed applicant for BUD MAXILLOFACIAL IMPLANT SYSTEM?

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

What is the FDA product code for BUD MAXILLOFACIAL IMPLANT SYSTEM?

The FDA product code for BUD MAXILLOFACIAL IMPLANT SYSTEM is JEY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bud Industries, 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.

K912521DENTAL IMPLANT SYSTEM 4.0MM AND 5.5MM LENGTHK902331BUD DENTAL IMPLANT SYSTEM

Related Devices (Code: JEY)

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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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