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)

VISIO-SEAL

K-Number: K810950 · 1981-04-29

ApplicantEspe Dental Products
Decision Date1981-04-29
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VISIO-SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Espe Dental Products. It received FDA 510(k) clearance on 1981-04-29 under 510(k) number K810950. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISIO-SEAL?

VISIO-SEAL is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Espe Dental Products. The 510(k) number is K810950.

When did VISIO-SEAL receive FDA 510(k) clearance?

VISIO-SEAL received FDA 510(k) clearance on 1981-04-29, under 510(k) number K810950.

Who is the listed applicant for VISIO-SEAL?

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

What is the FDA product code for VISIO-SEAL?

The FDA product code for VISIO-SEAL is EBC.

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 Espe Dental Products 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.

K802819KETAC-CEM IN REF. TO K802048K802049NIMETIC-DISPERSK800031PERMADYNE POLYETHER RUBBER IMPRESSIONK771901CAPMIXK771889UNIOLITEK771120IMPREFLEX ALGINATE IMPRESSION MATERIAL

View all 8 devices →

Related Devices (Code: EBC)

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.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG

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.

↑