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)

DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER

K-Number: K881245 · 1988-07-21

ApplicantCadco Dental Products, Inc.
Decision Date1988-07-21
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER is the device name listed in this FDA 510(k) record. The listed applicant is Cadco Dental Products, Inc.. It received FDA 510(k) clearance on 1988-07-21 under 510(k) number K881245. 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 DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER?

DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER is a medical device that received FDA 510(k) clearance on 1988-07-21. The listed applicant is Cadco Dental Products, Inc.. The 510(k) number is K881245.

When did DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER receive FDA 510(k) clearance?

DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER received FDA 510(k) clearance on 1988-07-21, under 510(k) number K881245.

Who is the listed applicant for DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER?

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

What is the FDA product code for DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER?

The FDA product code for DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER 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 Cadco Dental 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.

K860487URENAMEL, POSTERIOR RESTORATIVE MATERIAL

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.

↑