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FDA 510(k)

DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED

K-Number: K963548 · 1997-01-22

ApplicantMrlb Intl., Inc.
Decision Date1997-01-22
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED is the device name listed in this FDA 510(k) record. The listed applicant is Mrlb Intl., Inc.. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K963548. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED?

DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Mrlb Intl., Inc.. The 510(k) number is K963548.

When did DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED receive FDA 510(k) clearance?

DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED received FDA 510(k) clearance on 1997-01-22, under 510(k) number K963548.

Who is the listed applicant for DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED?

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

What is the FDA product code for DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED?

The FDA product code for DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED is EIA.

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 Mrlb Intl., 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.

K992893DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGEK992868DENTAPURE DP40 CARTRIDGE

Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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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