Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HIGH-Q-BOND

K-Number: K933766 · 1994-01-26

ApplicantSilmet U.S.A. Corp.
Decision Date1994-01-26
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HIGH-Q-BOND is the device name listed in this FDA 510(k) record. The listed applicant is Silmet U.S.A. Corp.. It received FDA 510(k) clearance on 1994-01-26 under 510(k) number K933766. 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 HIGH-Q-BOND?

HIGH-Q-BOND is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is Silmet U.S.A. Corp.. The 510(k) number is K933766.

When did HIGH-Q-BOND receive FDA 510(k) clearance?

HIGH-Q-BOND received FDA 510(k) clearance on 1994-01-26, under 510(k) number K933766.

Who is the listed applicant for HIGH-Q-BOND?

The FDA 510(k) record lists Silmet U.S.A. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIGH-Q-BOND?

The FDA product code for HIGH-Q-BOND is EBF.

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.

↑