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)

PORTA MAXIMUM, MODEL# 2066

K-Number: K012835 · 2001-11-01

ApplicantWieland Edelmetalle GmbH & Co.
Decision Date2001-11-01
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PORTA MAXIMUM, MODEL# 2066 is the device name listed in this FDA 510(k) record. The listed applicant is Wieland Edelmetalle GmbH & Co.. It received FDA 510(k) clearance on 2001-11-01 under 510(k) number K012835. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTA MAXIMUM, MODEL# 2066?

PORTA MAXIMUM, MODEL# 2066 is a medical device that received FDA 510(k) clearance on 2001-11-01. The listed applicant is Wieland Edelmetalle GmbH & Co.. The 510(k) number is K012835.

When did PORTA MAXIMUM, MODEL# 2066 receive FDA 510(k) clearance?

PORTA MAXIMUM, MODEL# 2066 received FDA 510(k) clearance on 2001-11-01, under 510(k) number K012835.

Who is the listed applicant for PORTA MAXIMUM, MODEL# 2066?

The FDA 510(k) record lists Wieland Edelmetalle GmbH & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTA MAXIMUM, MODEL# 2066?

The FDA product code for PORTA MAXIMUM, MODEL# 2066 is EJT.

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 Wieland Edelmetalle GmbH & Co. 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.

K020347AGC SPEZIALLEGIERUNGK012839AUROPAL, ORDER-NO.: 2101K012841DUO PAL 6, ORDER-NO.: 2154K012843PORTADUR P 2, MODEL #2031K012827PORTA AURIUM, MODEL 2067K012828PORTA SMK 82, MODEL 2032

View all 14 devices →

Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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.

↑