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FDA 510(k)

TCB TEMPORARY CROWN AND BRIDGE MATERIAL

K-Number: K964691 · 1997-02-04

ApplicantScican
Decision Date1997-02-04
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TCB TEMPORARY CROWN AND BRIDGE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Scican. It received FDA 510(k) clearance on 1997-02-04 under 510(k) number K964691. 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 TCB TEMPORARY CROWN AND BRIDGE MATERIAL?

TCB TEMPORARY CROWN AND BRIDGE MATERIAL is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Scican. The 510(k) number is K964691.

When did TCB TEMPORARY CROWN AND BRIDGE MATERIAL receive FDA 510(k) clearance?

TCB TEMPORARY CROWN AND BRIDGE MATERIAL received FDA 510(k) clearance on 1997-02-04, under 510(k) number K964691.

Who is the listed applicant for TCB TEMPORARY CROWN AND BRIDGE MATERIAL?

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

What is the FDA product code for TCB TEMPORARY CROWN AND BRIDGE MATERIAL?

The FDA product code for TCB TEMPORARY CROWN AND BRIDGE MATERIAL is EBG.

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Other records listing Scican 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.

K062418K-SPRAY, MODEL 085-2715K021064QUANTIM 16 AUTOCLAVEK983679STATIM 5000 CASSETTE AUTOCLAVEK962179STAT IM 5000 CASSETTE AUTOCLAVEK944036STERIMASTER AUTOCLAVEK945142POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)

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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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