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)

THERMOCRAFT PORCELAIN

K-Number: K840642 · 1984-03-30

ApplicantAmerican Thermocraft Corp.
Decision Date1984-03-30
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THERMOCRAFT PORCELAIN is the device name listed in this FDA 510(k) record. The listed applicant is American Thermocraft Corp.. It received FDA 510(k) clearance on 1984-03-30 under 510(k) number K840642. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOCRAFT PORCELAIN?

THERMOCRAFT PORCELAIN is a medical device that received FDA 510(k) clearance on 1984-03-30. The listed applicant is American Thermocraft Corp.. The 510(k) number is K840642.

When did THERMOCRAFT PORCELAIN receive FDA 510(k) clearance?

THERMOCRAFT PORCELAIN received FDA 510(k) clearance on 1984-03-30, under 510(k) number K840642.

Who is the listed applicant for THERMOCRAFT PORCELAIN?

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

What is the FDA product code for THERMOCRAFT PORCELAIN?

The FDA product code for THERMOCRAFT PORCELAIN is ELL.

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: ELL)

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.

K240586Additive Manufacturing Zirconia Customized RestorationHangzhou Thales Medtech Co., Ltd.K203072Franz Zirconia Dental CrownFranz Biotech, Inc.K162043NobelProcera HT ML FCZ BridgeNobel Biocare ABK153534NobelProcera HT ML Full Contour Zirconia CrownNobel Biocare ABK071182PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013Nobel Biocare ABK060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.Lifecore Biomedical, 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.

↑