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FDA 510(k)

SILANIT

K-Number: K802679 · 1980-12-17

ApplicantVivadent (Usa), Inc.
Decision Date1980-12-17
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILANIT is the device name listed in this FDA 510(k) record. The listed applicant is Vivadent (Usa), Inc.. It received FDA 510(k) clearance on 1980-12-17 under 510(k) number K802679. 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 SILANIT?

SILANIT is a medical device that received FDA 510(k) clearance on 1980-12-17. The listed applicant is Vivadent (Usa), Inc.. The 510(k) number is K802679.

When did SILANIT receive FDA 510(k) clearance?

SILANIT received FDA 510(k) clearance on 1980-12-17, under 510(k) number K802679.

Who is the listed applicant for SILANIT?

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

What is the FDA product code for SILANIT?

The FDA product code for SILANIT is EBG.

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.

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Other records listing Vivadent (Usa), Inc. 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.

K863831VIVADENT FILPINK823409HELIOSIT-ORTHODONTICK813015HELIOSEALK802683HELIOSITK802681HELIOBONDK802682CONTACT SEAL

View all 17 devices →

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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