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)

ODONTOSURGE 2

K-Number: K981390 · 1998-06-11

ApplicantPeriogiene
Decision Date1998-06-11
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ODONTOSURGE 2 is the device name listed in this FDA 510(k) record. The listed applicant is Periogiene. It received FDA 510(k) clearance on 1998-06-11 under 510(k) number K981390. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ODONTOSURGE 2?

ODONTOSURGE 2 is a medical device that received FDA 510(k) clearance on 1998-06-11. The listed applicant is Periogiene. The 510(k) number is K981390.

When did ODONTOSURGE 2 receive FDA 510(k) clearance?

ODONTOSURGE 2 received FDA 510(k) clearance on 1998-06-11, under 510(k) number K981390.

Who is the listed applicant for ODONTOSURGE 2?

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

What is the FDA product code for ODONTOSURGE 2?

The FDA product code for ODONTOSURGE 2 is EKZ.

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

Related Devices (Code: EKZ)

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.

K213477Root ZX3J. Morita USA, Inc.K071632PERFECT TISSUE CONTOURING SYSTEM IIColtene/Whaledent, Inc.K063468THE FUGO BLADE FOR DENTISTRYMedisurg , Ltd.K052622MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNITMacan Engineering Co.K050735MC6AMacan Engineering Co.K023672X O ODONTOSURGE 4Xo Care A/S

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.

↑