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FDA 510(k)

SOLARCRY/TEMPORARY CROWN & BRIDGE MAT

K-Number: K831294 · 1983-08-31

ApplicantSolar Dental Co., Inc.
Decision Date1983-08-31
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLARCRY/TEMPORARY CROWN & BRIDGE MAT is the device name listed in this FDA 510(k) record. The listed applicant is Solar Dental Co., Inc.. It received FDA 510(k) clearance on 1983-08-31 under 510(k) number K831294. 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 SOLARCRY/TEMPORARY CROWN & BRIDGE MAT?

SOLARCRY/TEMPORARY CROWN & BRIDGE MAT is a medical device that received FDA 510(k) clearance on 1983-08-31. The listed applicant is Solar Dental Co., Inc.. The 510(k) number is K831294.

When did SOLARCRY/TEMPORARY CROWN & BRIDGE MAT receive FDA 510(k) clearance?

SOLARCRY/TEMPORARY CROWN & BRIDGE MAT received FDA 510(k) clearance on 1983-08-31, under 510(k) number K831294.

Who is the listed applicant for SOLARCRY/TEMPORARY CROWN & BRIDGE MAT?

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

What is the FDA product code for SOLARCRY/TEMPORARY CROWN & BRIDGE MAT?

The FDA product code for SOLARCRY/TEMPORARY CROWN & BRIDGE MAT 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.

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 Solar Dental Co., 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.

K871980D-23 DENTURE ADHESIVEK861846HYDRON ROOT CANAL FILLING & MARK IV STARTER KITK852926DENTOLOCK II DENTURE ADHESIVE CREAMK831293SOLARCRYL CUSTOM TRAY MATERIALK831265DENTOLOCK DENTURE ADHESIVE CREAM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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