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FDA 510(k)

PROPHYLAXIS CUP.

K-Number: K803155 · 1981-01-08

ApplicantTeledyne Densco
Decision Date1981-01-08
Product CodeEHK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROPHYLAXIS CUP. is the device name listed in this FDA 510(k) record. The listed applicant is Teledyne Densco. It received FDA 510(k) clearance on 1981-01-08 under 510(k) number K803155. The device is classified under product code EHK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPHYLAXIS CUP.?

PROPHYLAXIS CUP. is a medical device that received FDA 510(k) clearance on 1981-01-08. The listed applicant is Teledyne Densco. The 510(k) number is K803155.

When did PROPHYLAXIS CUP. receive FDA 510(k) clearance?

PROPHYLAXIS CUP. received FDA 510(k) clearance on 1981-01-08, under 510(k) number K803155.

Who is the listed applicant for PROPHYLAXIS CUP.?

The FDA 510(k) record lists Teledyne Densco as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROPHYLAXIS CUP.?

The FDA product code for PROPHYLAXIS CUP. is EHK.

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 Teledyne Densco 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.

K821686DENSCO PROPHY ANGLEK821364PROFLEX FLEXIBLE SCALERK780641DENTAL ROTARY CARBIDE BURS 76EJL

Related Devices (Code: EHK)

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.

K953628PROPHY ANGLERolence Enterprise Co. , Ltd.K951016DISPOSABLE PROPHYLAXIS ANGLEPreventive Technologies, Inc.K900507DISPOSABLE SCREW TYPE PROPHY BRUSHDentsply Intl.K864059DENTAL PROPHY CUPS (VARIOUS TYPES)Mission White Dental, Inc.K790723PROPHYLAXIS CUPS AND POLISHERSYoung Dental Manufacturing Co. 1, LLCK780198PROPHY CUPS, R&RRansom and Randolph

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.

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