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)

LUCITONE FRS FLEXIBEL DENTAL RESIN

K-Number: K992956 · 1999-10-06

ApplicantDentsply Intl.
Decision Date1999-10-06
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUCITONE FRS FLEXIBEL DENTAL RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1999-10-06 under 510(k) number K992956. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUCITONE FRS FLEXIBEL DENTAL RESIN?

LUCITONE FRS FLEXIBEL DENTAL RESIN is a medical device that received FDA 510(k) clearance on 1999-10-06. The listed applicant is Dentsply Intl.. The 510(k) number is K992956.

When did LUCITONE FRS FLEXIBEL DENTAL RESIN receive FDA 510(k) clearance?

LUCITONE FRS FLEXIBEL DENTAL RESIN received FDA 510(k) clearance on 1999-10-06, under 510(k) number K992956.

Who is the listed applicant for LUCITONE FRS FLEXIBEL DENTAL RESIN?

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

What is the FDA product code for LUCITONE FRS FLEXIBEL DENTAL RESIN?

The FDA product code for LUCITONE FRS FLEXIBEL DENTAL RESIN is EBI.

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 Dentsply Intl. 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.

K123615IRIS - HIGH STRENGTH GLASS CERAMICK072730FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTSK070538XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVEK070019CARRARA VOLUMIAK061427PRE-IMPRESSION CONDITIONING SOLUTIONK052334CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131

View all 279 devices →

Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

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.

↑