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)

AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM

K-Number: K022217 · 2002-10-24

ApplicantAseptico, Inc.
Decision Date2002-10-24
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aseptico, Inc.. It received FDA 510(k) clearance on 2002-10-24 under 510(k) number K022217. 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 AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM?

AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM is a medical device that received FDA 510(k) clearance on 2002-10-24. The listed applicant is Aseptico, Inc.. The 510(k) number is K022217.

When did AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM receive FDA 510(k) clearance?

AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM received FDA 510(k) clearance on 2002-10-24, under 510(k) number K022217.

Who is the listed applicant for AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM?

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

What is the FDA product code for AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM?

The FDA product code for AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM 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 Aseptico, 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.

K130693AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEMK111078AEU-26L ELCTRONIC ENDODONTIC SYSTEMK101332AMC-20 PORTABLE DENTAL CART MODEL AMC-20K103399GENERAL DENISTRY MOTORK070866ASC-12 PIEZOELECTRIC SCALERK051077E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101

View all 16 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑