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)

KERR SEALAPEX ROOT CANAL SEALER

K-Number: K841910 · 1984-07-13

ApplicantSybron Corp.
Decision Date1984-07-13
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KERR SEALAPEX ROOT CANAL SEALER is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Corp.. It received FDA 510(k) clearance on 1984-07-13 under 510(k) number K841910. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KERR SEALAPEX ROOT CANAL SEALER?

KERR SEALAPEX ROOT CANAL SEALER is a medical device that received FDA 510(k) clearance on 1984-07-13. The listed applicant is Sybron Corp.. The 510(k) number is K841910.

When did KERR SEALAPEX ROOT CANAL SEALER receive FDA 510(k) clearance?

KERR SEALAPEX ROOT CANAL SEALER received FDA 510(k) clearance on 1984-07-13, under 510(k) number K841910.

Who is the listed applicant for KERR SEALAPEX ROOT CANAL SEALER?

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

What is the FDA product code for KERR SEALAPEX ROOT CANAL SEALER?

The FDA product code for KERR SEALAPEX ROOT CANAL SEALER is EJK.

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 Sybron Corp. 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.

K862284SEALITEK854855PROOF ALGINATE IMPRESSION MATERIALK844092DIAGNOSTIC MICROSOPCE SLIDESK842132TYCOS SELF-CHECK/DIGITAL FEVER THERMOK841732LIEBEL-FLARSHEIM AFC 1000 X-RAY FILMK840407KERR RESIN BONDED BRIDGE CEMENT

View all 37 devices →

Related Devices (Code: EJK)

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.

K261728One-Fil LCMediclus Co., Ltd.K253248Bright Cavity LinerDmp Dental Industry S.A.K2302703M™ VitCal Liner/Base3M Espe Dental ProductsK212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro LimitedK201799CleaniCalMaruchiK202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH

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.

↑