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FDA 510(k)

PRE-DENT SYSTEM OR PRE-DENT II

K-Number: K801386 · 1980-07-14

ApplicantPre-Dent System
Decision Date1980-07-14
Product CodeKSS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PRE-DENT SYSTEM OR PRE-DENT II is the device name listed in this FDA 510(k) record. The listed applicant is Pre-Dent System. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801386. The device is classified under product code KSS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-DENT SYSTEM OR PRE-DENT II?

PRE-DENT SYSTEM OR PRE-DENT II is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Pre-Dent System. The 510(k) number is K801386.

When did PRE-DENT SYSTEM OR PRE-DENT II receive FDA 510(k) clearance?

PRE-DENT SYSTEM OR PRE-DENT II received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801386.

Who is the listed applicant for PRE-DENT SYSTEM OR PRE-DENT II?

The FDA 510(k) record lists Pre-Dent System as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRE-DENT SYSTEM OR PRE-DENT II?

The FDA product code for PRE-DENT SYSTEM OR PRE-DENT II is KSS.

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 Pre-Dent System 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.

K801516PRE-DENT SYSTEM MODIFIEDK800736PRE-DENT SYSTEM

Related Devices (Code: KSS)

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.

K874436FLUID SAMPLING PACKU.S. Mfg. & Management, Inc.K812892S/P SERUM DROPPER PIPETSAmerican DadeK801516PRE-DENT SYSTEM MODIFIEDPre-Dent SystemK800736PRE-DENT SYSTEMPre-Dent SystemK761303IMMU-SAL IMMUNOHEMATOLOGICAL SALINEDade, Baxter Travenol Diagnostics, Inc.

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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