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)

EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804

K-Number: K014144 · 2002-02-07

ApplicantAfp Imaging Corp.
Decision Date2002-02-07
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 is the device name listed in this FDA 510(k) record. The listed applicant is Afp Imaging Corp.. It received FDA 510(k) clearance on 2002-02-07 under 510(k) number K014144. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804?

EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 is a medical device that received FDA 510(k) clearance on 2002-02-07. The listed applicant is Afp Imaging Corp.. The 510(k) number is K014144.

When did EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 receive FDA 510(k) clearance?

EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 received FDA 510(k) clearance on 2002-02-07, under 510(k) number K014144.

Who is the listed applicant for EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804?

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

What is the FDA product code for EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804?

The FDA product code for EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 is EBF.

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 Afp Imaging Corp. 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.

K123419EVA SELECT DIGITAL DENTAL IMAGING SYSTEMK072357NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEMK041120EV APAN DIGITAL, MODEL K1VSM2000K030647EVA DIGITAL DENTAL X-RAY SYSTEMK013176MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWAREK974619SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM

View all 13 devices →

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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.

↑