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)

ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE

K-Number: K921600 · 1992-09-28

ApplicantUltradent Products, Inc.
Decision Date1992-09-28
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 1992-09-28 under 510(k) number K921600. 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 ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE?

ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE is a medical device that received FDA 510(k) clearance on 1992-09-28. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K921600.

When did ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE receive FDA 510(k) clearance?

ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE received FDA 510(k) clearance on 1992-09-28, under 510(k) number K921600.

Who is the listed applicant for ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE?

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

What is the FDA product code for ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE?

The FDA product code for ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE 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 Ultradent Products, Inc. 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.

K262228Transcend Bulk Fill Flowable CompositeK261404UltraEZK240743Peak Universal BondK240694FORMA Composite (Shade A3D)K221909J-TempK220471VALO X, VALO X Accessory Lenses

View all 102 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.

↑