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FDA 510(k)

ETCHING GEL

K-Number: K991450 · 1999-07-09

ApplicantSilicon-Und Composite Spezialitaten GmbH
Decision Date1999-07-09
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ETCHING GEL 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 1999-07-09 under 510(k) number K991450. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETCHING GEL?

ETCHING GEL is a medical device that received FDA 510(k) clearance on 1999-07-09. The listed applicant is Silicon-Und Composite Spezialitaten GmbH. The 510(k) number is K991450.

When did ETCHING GEL receive FDA 510(k) clearance?

ETCHING GEL received FDA 510(k) clearance on 1999-07-09, under 510(k) number K991450.

Who is the listed applicant for ETCHING GEL?

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 ETCHING GEL?

The FDA product code for ETCHING GEL is EBF.

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-LINKK960938PROV-KBK953476MULTI-PRIME AKA/MONO-PRIME

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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