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FDA 510(k)

DENTAL ORAL CARE SYSTEMS & COMPONENTS

K-Number: K844480 · 1985-06-19

ApplicantAdvanced Bio Systems, Inc.
Decision Date1985-06-19
Product CodeEBO
Advisory CommitteeDE
DecisionSubstantially Equivalent for Some Indications

Device Summary

DENTAL ORAL CARE SYSTEMS & COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Bio Systems, Inc.. It received FDA 510(k) clearance on 1985-06-19 under 510(k) number K844480. The device is classified under product code EBO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DENTAL ORAL CARE SYSTEMS & COMPONENTS?

DENTAL ORAL CARE SYSTEMS & COMPONENTS is a medical device that received FDA 510(k) clearance on 1985-06-19. The listed applicant is Advanced Bio Systems, Inc.. The 510(k) number is K844480.

When did DENTAL ORAL CARE SYSTEMS & COMPONENTS receive FDA 510(k) clearance?

DENTAL ORAL CARE SYSTEMS & COMPONENTS received FDA 510(k) clearance on 1985-06-19, under 510(k) number K844480.

Who is the listed applicant for DENTAL ORAL CARE SYSTEMS & COMPONENTS?

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

What is the FDA product code for DENTAL ORAL CARE SYSTEMS & COMPONENTS?

The FDA product code for DENTAL ORAL CARE SYSTEMS & COMPONENTS is EBO.

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 Advanced Bio Systems, 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.

K840616MINI-PUMP U-100

Related Devices (Code: EBO)

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.

K850927COMPLETE DENTURE REPAIR KITTooth Aid Lab, Inc.K833056UNIVERSAL LINE-A-PLATELaurentian LaboratoriesK833057UNIVERSAL FIX-A-PLATELaurentian LaboratoriesK820245SAFE TDENTProfessional Dental StudiosK820685DENTURE ADJUSTMENT KITCamdent LaboratoriesK770091EMERGENCY FAST-FIX DENTURE REPAIR KITMr. Clarence Hurst

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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