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)

PREMIER SELF-ETCHING ENAMEL SEALANT

K-Number: K061997 · 2006-10-04

ApplicantPremier Dental Products Co.
Decision Date2006-10-04
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIER SELF-ETCHING ENAMEL SEALANT is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Co.. It received FDA 510(k) clearance on 2006-10-04 under 510(k) number K061997. 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 PREMIER SELF-ETCHING ENAMEL SEALANT?

PREMIER SELF-ETCHING ENAMEL SEALANT is a medical device that received FDA 510(k) clearance on 2006-10-04. The listed applicant is Premier Dental Products Co.. The 510(k) number is K061997.

When did PREMIER SELF-ETCHING ENAMEL SEALANT receive FDA 510(k) clearance?

PREMIER SELF-ETCHING ENAMEL SEALANT received FDA 510(k) clearance on 2006-10-04, under 510(k) number K061997.

Who is the listed applicant for PREMIER SELF-ETCHING ENAMEL SEALANT?

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

What is the FDA product code for PREMIER SELF-ETCHING ENAMEL SEALANT?

The FDA product code for PREMIER SELF-ETCHING ENAMEL SEALANT 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 Premier Dental Products Co. 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.

K132526KNIT-PAK+K131212PREMIER CERAMIC PRIMERK083695TRAXODENTK062683ENAMEL PRO VARNISHK062166ENAMEL PROK061998PREMIER SELF-ETCHING BOND ENHANCER

View all 40 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.

↑