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FDA 510(k)

ULTRAFIL-LT (GUTTA PERCHA)

K-Number: K850863 · 1985-04-16

ApplicantThe Hygenic Corp.
Decision Date1985-04-16
Product CodeEKM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRAFIL-LT (GUTTA PERCHA) 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 1985-04-16 under 510(k) number K850863. The device is classified under product code EKM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAFIL-LT (GUTTA PERCHA)?

ULTRAFIL-LT (GUTTA PERCHA) is a medical device that received FDA 510(k) clearance on 1985-04-16. The listed applicant is The Hygenic Corp.. The 510(k) number is K850863.

When did ULTRAFIL-LT (GUTTA PERCHA) receive FDA 510(k) clearance?

ULTRAFIL-LT (GUTTA PERCHA) received FDA 510(k) clearance on 1985-04-16, under 510(k) number K850863.

Who is the listed applicant for ULTRAFIL-LT (GUTTA PERCHA)?

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 ULTRAFIL-LT (GUTTA PERCHA)?

The FDA product code for ULTRAFIL-LT (GUTTA PERCHA) is EKM.

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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 DOUGHK905640SOLID CORE GUTTA PERCHA CARRIERK900301NOVUS BONDING AGENT

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Related Devices (Code: EKM)

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.

K073369EI DOWNPAK BARRIER SLEEVESHu-Friedy Mfg. Co., Inc.K070246DOWN PAKEndo Twinn B.V.K051573TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)Dr. Howard Martin, P.A.K042870ENDO TWINNEndo Twinn B.V.K023819FIBERFILL SGPPentron Clinical TechnologiesK971641ANTIBACTERIAL GUTTA PERCHADr. Howard Martin, P.A.

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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