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FDA 510(k)

SOLID CORE GUTTA PERCHA CARRIER

K-Number: K905640 · 1991-03-05

ApplicantThe Hygenic Corp.
Decision Date1991-03-05
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLID CORE GUTTA PERCHA CARRIER is the device name listed in this FDA 510(k) record. The listed applicant is The Hygenic Corp.. It received FDA 510(k) clearance on 1991-03-05 under 510(k) number K905640. The device is classified under product code EKS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLID CORE GUTTA PERCHA CARRIER?

SOLID CORE GUTTA PERCHA CARRIER is a medical device that received FDA 510(k) clearance on 1991-03-05. The listed applicant is The Hygenic Corp.. The 510(k) number is K905640.

When did SOLID CORE GUTTA PERCHA CARRIER receive FDA 510(k) clearance?

SOLID CORE GUTTA PERCHA CARRIER received FDA 510(k) clearance on 1991-03-05, under 510(k) number K905640.

Who is the listed applicant for SOLID CORE GUTTA PERCHA CARRIER?

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

What is the FDA product code for SOLID CORE GUTTA PERCHA CARRIER?

The FDA product code for SOLID CORE GUTTA PERCHA CARRIER is EKS.

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Other records listing The Hygenic 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.

K954990DENTAL DAMK930764ENDO-ICE-PULP TESTER-THERMALK905418GATES GLIDDEN DRILLSK911225TRAY DOUGHK900301NOVUS BONDING AGENTK900844WEDJETS

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Related Devices (Code: EKS)

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.

K062856TF ROTARY NICKEL TITANIUM FILEOrmco Corp.K004031NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILESDental Power, Inc.K971319NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTycom DentalK970649HERO 642Micro-MegaK962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom DentalK953604SHAPING HEDSTROM N.T.Sybron Dental Specialties, Inc.

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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