免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

TheraBreath干口口腔漱口水，TheraBreath干口含片

K号: K171542 · 2018-03-16

申请人Dr. Harold Katz, LLC (Dba Therabreath
决定日期2018-03-16
产品代码LFD
决定实质等同

器械摘要

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Harold Katz, LLC (Dba Therabreath. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K171542. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

常见问题

What is the TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges?

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Dr. Harold Katz, LLC (Dba Therabreath. The 510(k) number is K171542.

When did TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges receive FDA 510(k) clearance?

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges received FDA 510(k) clearance on 2018-03-16, under 510(k) number K171542.

Who is the listed applicant for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges?

The FDA 510(k) record lists Dr. Harold Katz, LLC (Dba Therabreath as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges?

The FDA product code for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges is LFD.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：LFD）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253778Allday 润肤漱口水Elevate Oral CareK250390CloSYS®干口敏感漱口水Rowpar Pharmaceuticals, Inc.K240508Salivea干口保湿凝胶（干口保湿凝胶）Laclede, Inc.K234015Caphosol® 人工唾液 (32 剂量袋装盒)Eusa Pharma (Uk) LimitedK231205GuruNanda干口口腔漱口水及GuruNanda干口口腔喷雾剂Gurunanda, LLCK202689Dentilube SprayOxy2plus, LLC

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

↑