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FDA 510(k)

TEMPFIL

K-Number: K013895 · 2002-02-04

ApplicantSybron Dental Specialties, Inc.
Decision Date2002-02-04
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPFIL is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 2002-02-04 under 510(k) number K013895. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPFIL?

TEMPFIL is a medical device that received FDA 510(k) clearance on 2002-02-04. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K013895.

When did TEMPFIL receive FDA 510(k) clearance?

TEMPFIL received FDA 510(k) clearance on 2002-02-04, under 510(k) number K013895.

Who is the listed applicant for TEMPFIL?

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

What is the FDA product code for TEMPFIL?

The FDA product code for TEMPFIL is EBG.

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Other records listing Sybron Dental Specialties, Inc. as applicant

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Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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.

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