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)

TROLL-BITE

K-Number: K853451 · 1986-01-21

ApplicantTrollplast, Inc.
Decision Date1986-01-21
Product CodeEGZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TROLL-BITE is the device name listed in this FDA 510(k) record. The listed applicant is Trollplast, Inc.. It received FDA 510(k) clearance on 1986-01-21 under 510(k) number K853451. The device is classified under product code EGZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROLL-BITE?

TROLL-BITE is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Trollplast, Inc.. The 510(k) number is K853451.

When did TROLL-BITE receive FDA 510(k) clearance?

TROLL-BITE received FDA 510(k) clearance on 1986-01-21, under 510(k) number K853451.

Who is the listed applicant for TROLL-BITE?

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

What is the FDA product code for TROLL-BITE?

The FDA product code for TROLL-BITE is EGZ.

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

Related Devices (Code: EGZ)

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.

K913168SALIBAGNix Co. , Ltd.K913160ID-TABNix Co. , Ltd.K890355DENTAL X-RAY BITE BLOCKBite-A-BlockK852170EZX YELLOW, BLUE OR ORANGEStrong MarketingK853005S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARMThe S. S. White Co.K813378UNI-BITE DENTAL X-RAY FILM HOLDERRinn Corp.

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.

↑