Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SAFE TDENT

K-Number: K820245 · 1982-04-09

ApplicantProfessional Dental Studios
Decision Date1982-04-09
Product CodeEBO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAFE TDENT is the device name listed in this FDA 510(k) record. The listed applicant is Professional Dental Studios. It received FDA 510(k) clearance on 1982-04-09 under 510(k) number K820245. The device is classified under product code EBO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFE TDENT?

SAFE TDENT is a medical device that received FDA 510(k) clearance on 1982-04-09. The listed applicant is Professional Dental Studios. The 510(k) number is K820245.

When did SAFE TDENT receive FDA 510(k) clearance?

SAFE TDENT received FDA 510(k) clearance on 1982-04-09, under 510(k) number K820245.

Who is the listed applicant for SAFE TDENT?

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

What is the FDA product code for SAFE TDENT?

The FDA product code for SAFE TDENT 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

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.K844480DENTAL ORAL CARE SYSTEMS & COMPONENTSAdvanced Bio Systems, Inc.K833056UNIVERSAL LINE-A-PLATELaurentian LaboratoriesK833057UNIVERSAL FIX-A-PLATELaurentian LaboratoriesK820685DENTURE ADJUSTMENT KITCamdent LaboratoriesK770091EMERGENCY FAST-FIX DENTURE REPAIR KITMr. Clarence Hurst

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.

↑