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)

BONDALCAP (CARBOXYLATE)

K-Number: K801229 · 1980-06-04

ApplicantVivadent (Usa), Inc.
Decision Date1980-06-04
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONDALCAP (CARBOXYLATE) is the device name listed in this FDA 510(k) record. The listed applicant is Vivadent (Usa), Inc.. It received FDA 510(k) clearance on 1980-06-04 under 510(k) number K801229. 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 BONDALCAP (CARBOXYLATE)?

BONDALCAP (CARBOXYLATE) is a medical device that received FDA 510(k) clearance on 1980-06-04. The listed applicant is Vivadent (Usa), Inc.. The 510(k) number is K801229.

When did BONDALCAP (CARBOXYLATE) receive FDA 510(k) clearance?

BONDALCAP (CARBOXYLATE) received FDA 510(k) clearance on 1980-06-04, under 510(k) number K801229.

Who is the listed applicant for BONDALCAP (CARBOXYLATE)?

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

What is the FDA product code for BONDALCAP (CARBOXYLATE)?

The FDA product code for BONDALCAP (CARBOXYLATE) 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

Other records listing Vivadent (Usa), Inc. 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.

K863831VIVADENT FILPINK823409HELIOSIT-ORTHODONTICK813015HELIOSEALK802679SILANITK802682CONTACT SEALK802684HELIOMAT

View all 17 devices →

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.

↑