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)

ALPHA-BOND DENTIN BONDING SYSTEM

K-Number: K954177 · 1995-09-27

ApplicantAlpha-Bond, Inc.
Decision Date1995-09-27
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALPHA-BOND DENTIN BONDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alpha-Bond, Inc.. It received FDA 510(k) clearance on 1995-09-27 under 510(k) number K954177. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA-BOND DENTIN BONDING SYSTEM?

ALPHA-BOND DENTIN BONDING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-27. The listed applicant is Alpha-Bond, Inc.. The 510(k) number is K954177.

When did ALPHA-BOND DENTIN BONDING SYSTEM receive FDA 510(k) clearance?

ALPHA-BOND DENTIN BONDING SYSTEM received FDA 510(k) clearance on 1995-09-27, under 510(k) number K954177.

Who is the listed applicant for ALPHA-BOND DENTIN BONDING SYSTEM?

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

What is the FDA product code for ALPHA-BOND DENTIN BONDING SYSTEM?

The FDA product code for ALPHA-BOND DENTIN BONDING SYSTEM is EMA.

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

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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.

↑