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)

WILEY/ESPOSITO DENTAL GUARD

K-Number: K935713 · 1994-01-05

ApplicantFvtnks
Decision Date1994-01-05
Product CodeBRW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WILEY/ESPOSITO DENTAL GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Fvtnks. It received FDA 510(k) clearance on 1994-01-05 under 510(k) number K935713. The device is classified under product code BRW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WILEY/ESPOSITO DENTAL GUARD?

WILEY/ESPOSITO DENTAL GUARD is a medical device that received FDA 510(k) clearance on 1994-01-05. The listed applicant is Fvtnks. The 510(k) number is K935713.

When did WILEY/ESPOSITO DENTAL GUARD receive FDA 510(k) clearance?

WILEY/ESPOSITO DENTAL GUARD received FDA 510(k) clearance on 1994-01-05, under 510(k) number K935713.

Who is the listed applicant for WILEY/ESPOSITO DENTAL GUARD?

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

What is the FDA product code for WILEY/ESPOSITO DENTAL GUARD?

The FDA product code for WILEY/ESPOSITO DENTAL GUARD is BRW.

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 Fvtnks 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.

K945482DISPOSABLE, CPAP OXYGEN MASKK945440DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASKK940544DOUBLE TRACH SEIVEL CONNECTOR

Related Devices (Code: BRW)

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.

K945727CATCO NEONATAL PALATE GUARDCatco Medical, Inc.K851640TIP TOLEDO INCISOR PROTECTOREdward O. Goodwich

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.

↑