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FDA 510(k)

MULTI-PRIME AKA/MONO-PRIME

K-Number: K953476 · 1995-09-22

ApplicantSilicon-Und Composite Spezialitaten GmbH
Decision Date1995-09-22
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MULTI-PRIME AKA/MONO-PRIME is the device name listed in this FDA 510(k) record. The listed applicant is Silicon-Und Composite Spezialitaten GmbH. It received FDA 510(k) clearance on 1995-09-22 under 510(k) number K953476. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTI-PRIME AKA/MONO-PRIME?

MULTI-PRIME AKA/MONO-PRIME is a medical device that received FDA 510(k) clearance on 1995-09-22. The listed applicant is Silicon-Und Composite Spezialitaten GmbH. The 510(k) number is K953476.

When did MULTI-PRIME AKA/MONO-PRIME receive FDA 510(k) clearance?

MULTI-PRIME AKA/MONO-PRIME received FDA 510(k) clearance on 1995-09-22, under 510(k) number K953476.

Who is the listed applicant for MULTI-PRIME AKA/MONO-PRIME?

The FDA 510(k) record lists Silicon-Und Composite Spezialitaten GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTI-PRIME AKA/MONO-PRIME?

The FDA product code for MULTI-PRIME AKA/MONO-PRIME is KLE.

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 Silicon-Und Composite Spezialitaten GmbH 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.

K992001TRAY-LINKK991450ETCHING GELK960938PROV-KB

Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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