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)

RTR SYRINGE

K-Number: K063634 · 2007-05-11

ApplicantSeptodont
Decision Date2007-05-11
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RTR SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Septodont. It received FDA 510(k) clearance on 2007-05-11 under 510(k) number K063634. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RTR SYRINGE?

RTR SYRINGE is a medical device that received FDA 510(k) clearance on 2007-05-11. The listed applicant is Septodont. The 510(k) number is K063634.

When did RTR SYRINGE receive FDA 510(k) clearance?

RTR SYRINGE received FDA 510(k) clearance on 2007-05-11, under 510(k) number K063634.

Who is the listed applicant for RTR SYRINGE?

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

What is the FDA product code for RTR SYRINGE?

The FDA product code for RTR SYRINGE is LYC.

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 Septodont 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.

K212283BioRoot Flow 0.5g, BioRoot Flow 2gK211799Biodentine XP 500, Biodentine XP 200K172839ENDOSOLVK093711RACEGELK092251BIODENTINEK051010SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70

View all 8 devices →

Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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.

↑