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)

STRAUMANN GUIDED INSTRUMENTS

K-Number: K082532 · 2008-10-21

ApplicantStraumann USA
Decision Date2008-10-21
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRAUMANN GUIDED INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA. It received FDA 510(k) clearance on 2008-10-21 under 510(k) number K082532. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRAUMANN GUIDED INSTRUMENTS?

STRAUMANN GUIDED INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2008-10-21. The listed applicant is Straumann USA. The 510(k) number is K082532.

When did STRAUMANN GUIDED INSTRUMENTS receive FDA 510(k) clearance?

STRAUMANN GUIDED INSTRUMENTS received FDA 510(k) clearance on 2008-10-21, under 510(k) number K082532.

Who is the listed applicant for STRAUMANN GUIDED INSTRUMENTS?

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

What is the FDA product code for STRAUMANN GUIDED INSTRUMENTS?

The FDA product code for STRAUMANN GUIDED INSTRUMENTS is DZI.

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 Straumann USA 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.

K151328PURE Ceramic ImplantsK130724CODIAGNOSTIX IMPLANT PLANNING SOFTWAREK130808STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWSK122855TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTSK121131BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MMK113606NNC GOLD ABUTMENT FOR BRIDGES

View all 41 devices →

Related Devices (Code: DZI)

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.

K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbHK253776Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbHK254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC

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.

↑