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)

GLUMA(TM) BONDING SYSTEM

K-Number: K871164 · 1987-07-02

ApplicantColumbus Dental Mfg. Co.
Decision Date1987-07-02
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLUMA(TM) BONDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Columbus Dental Mfg. Co.. It received FDA 510(k) clearance on 1987-07-02 under 510(k) number K871164. 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 GLUMA(TM) BONDING SYSTEM?

GLUMA(TM) BONDING SYSTEM is a medical device that received FDA 510(k) clearance on 1987-07-02. The listed applicant is Columbus Dental Mfg. Co.. The 510(k) number is K871164.

When did GLUMA(TM) BONDING SYSTEM receive FDA 510(k) clearance?

GLUMA(TM) BONDING SYSTEM received FDA 510(k) clearance on 1987-07-02, under 510(k) number K871164.

Who is the listed applicant for GLUMA(TM) BONDING SYSTEM?

The FDA 510(k) record lists Columbus Dental Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUMA(TM) BONDING SYSTEM?

The FDA product code for GLUMA(TM) BONDING SYSTEM 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 Columbus Dental Mfg. Co. 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.

K880754DRI-CLAVE LIQUID KLEENZALLK880607UTILITY WAX STRIPS, SPEARMINTK880606UTILITY WAX STRIPS, CINNAMONK872243PEKALUX(TM)K872272PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYSK871165LUMIFOR(TM) COMPOSITE

View all 11 devices →

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.

↑