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FDA 510(k)

STROBEX ULTRON ELECTROSURGE-DENTAL UNIT

K-Number: K850666 · 1985-05-29

ApplicantIpco Corp.
Decision Date1985-05-29
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STROBEX ULTRON ELECTROSURGE-DENTAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Ipco Corp.. It received FDA 510(k) clearance on 1985-05-29 under 510(k) number K850666. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STROBEX ULTRON ELECTROSURGE-DENTAL UNIT?

STROBEX ULTRON ELECTROSURGE-DENTAL UNIT is a medical device that received FDA 510(k) clearance on 1985-05-29. The listed applicant is Ipco Corp.. The 510(k) number is K850666.

When did STROBEX ULTRON ELECTROSURGE-DENTAL UNIT receive FDA 510(k) clearance?

STROBEX ULTRON ELECTROSURGE-DENTAL UNIT received FDA 510(k) clearance on 1985-05-29, under 510(k) number K850666.

Who is the listed applicant for STROBEX ULTRON ELECTROSURGE-DENTAL UNIT?

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

What is the FDA product code for STROBEX ULTRON ELECTROSURGE-DENTAL UNIT?

The FDA product code for STROBEX ULTRON ELECTROSURGE-DENTAL UNIT is EKZ.

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Other records listing Ipco Corp. 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.

K871270PERFORM DENTURE BASE RESINK850906TACTILE PLUS DENTAL ELEVATORSK842836SAFE & SOFT MINI PADS & MAXI PADSK842837SAFE & SOFT MAXI SHILEDSK842838SAFE & SOFT PANTY SHIELDSK841953ULTRA SHIELD BRIEFS

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Related Devices (Code: EKZ)

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.

K213477Root ZX3J. Morita USA, Inc.K071632PERFECT TISSUE CONTOURING SYSTEM IIColtene/Whaledent, Inc.K063468THE FUGO BLADE FOR DENTISTRYMedisurg , Ltd.K052622MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNITMacan Engineering Co.K050735MC6AMacan Engineering Co.K023672X O ODONTOSURGE 4Xo Care A/S

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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