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)

FISSURE SEALER

K-Number: K913853 · 1992-08-27

ApplicantOrtho Source
Decision Date1992-08-27
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FISSURE SEALER is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Source. It received FDA 510(k) clearance on 1992-08-27 under 510(k) number K913853. 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 FISSURE SEALER?

FISSURE SEALER is a medical device that received FDA 510(k) clearance on 1992-08-27. The listed applicant is Ortho Source. The 510(k) number is K913853.

When did FISSURE SEALER receive FDA 510(k) clearance?

FISSURE SEALER received FDA 510(k) clearance on 1992-08-27, under 510(k) number K913853.

Who is the listed applicant for FISSURE SEALER?

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

What is the FDA product code for FISSURE SEALER?

The FDA product code for 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 Ortho Source 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.

K913854ORTHO LIGHT CUREK913519SUMO GLASS IONOMER CEMENTK884949VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINERK884575MAXIBONDK861118ORTHOJOIN, ORTHODONTIC ADHESIVEK861258PERMABAND (ORTHODONTIC ADHESIVE)

View all 9 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.

↑