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FDA 510(k)

PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT)

K-Number: K901077 · 1990-05-29

ApplicantScientific Pharmaceuticals, Inc.
Decision Date1990-05-29
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT) is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1990-05-29 under 510(k) number K901077. 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 PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT)?

PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT) is a medical device that received FDA 510(k) clearance on 1990-05-29. The listed applicant is Scientific Pharmaceuticals, Inc.. The 510(k) number is K901077.

When did PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT) receive FDA 510(k) clearance?

PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT) received FDA 510(k) clearance on 1990-05-29, under 510(k) number K901077.

Who is the listed applicant for PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT)?

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

What is the FDA product code for PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT)?

The FDA product code for PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT) is EBG.

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Other records listing Scientific Pharmaceuticals, 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.

K051952EUGENONEK041886PROVISOK013555SCI-PHARM POST SECUREK001446LIGHT-CURED ORTHODONTIC BAND CEMENTK993324CARBOCEM ZINC POLYCARBOXYLATE CEMENTK982915SCI-PHARM DFV VARNISH

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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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