Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BRANEMARK SYSTEM-5.0MM FIXTURE

K-Number: K911961 · 1991-07-25

ApplicantNobelpharma USA, Inc.
Decision Date1991-07-25
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRANEMARK SYSTEM-5.0MM FIXTURE is the device name listed in this FDA 510(k) record. The listed applicant is Nobelpharma USA, Inc.. It received FDA 510(k) clearance on 1991-07-25 under 510(k) number K911961. 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 BRANEMARK SYSTEM-5.0MM FIXTURE?

BRANEMARK SYSTEM-5.0MM FIXTURE is a medical device that received FDA 510(k) clearance on 1991-07-25. The listed applicant is Nobelpharma USA, Inc.. The 510(k) number is K911961.

When did BRANEMARK SYSTEM-5.0MM FIXTURE receive FDA 510(k) clearance?

BRANEMARK SYSTEM-5.0MM FIXTURE received FDA 510(k) clearance on 1991-07-25, under 510(k) number K911961.

Who is the listed applicant for BRANEMARK SYSTEM-5.0MM FIXTURE?

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

What is the FDA product code for BRANEMARK SYSTEM-5.0MM FIXTURE?

The FDA product code for BRANEMARK SYSTEM-5.0MM FIXTURE is DZE.

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 Nobelpharma USA, 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.

K984162BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USEK962403NOBLEPHARMA WIDE ACCESSORIESK955713NOBELPHARMA BONE ANCHORED HEARING AIDK962130BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTUREK96173617 ANGULATED ABUTMENTK961737CERA ONE ABUTMENT SYSTEM

View all 64 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.

↑