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)

PAINT-ON-RESTORATIVE W/FISSURE SEALER

K-Number: K800391 · 1980-04-10

ApplicantAmerican Dental Research
Decision Date1980-04-10
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PAINT-ON-RESTORATIVE W/FISSURE SEALER is the device name listed in this FDA 510(k) record. The listed applicant is American Dental Research. It received FDA 510(k) clearance on 1980-04-10 under 510(k) number K800391. 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 PAINT-ON-RESTORATIVE W/FISSURE SEALER?

PAINT-ON-RESTORATIVE W/FISSURE SEALER is a medical device that received FDA 510(k) clearance on 1980-04-10. The listed applicant is American Dental Research. The 510(k) number is K800391.

When did PAINT-ON-RESTORATIVE W/FISSURE SEALER receive FDA 510(k) clearance?

PAINT-ON-RESTORATIVE W/FISSURE SEALER received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800391.

Who is the listed applicant for PAINT-ON-RESTORATIVE W/FISSURE SEALER?

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

What is the FDA product code for PAINT-ON-RESTORATIVE W/FISSURE SEALER?

The FDA product code for PAINT-ON-RESTORATIVE W/FISSURE SEALER 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 American Dental Research 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.

K800389ANTERIOR & POST. RESTORATIVE PASTE SYS.K800390ANT. & POST. RESTORATIVE POWDER LIQ.K800393POLY SULFIDE IMPRESSION PASTE W/CATALYSTK800392BRACKET BONDING SYSTEM METAL & PLASTIC

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.

↑