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FDA 510(k)

GUTTA PERCHA

K-Number: K863411 · 1986-10-30

ApplicantEndodent, Inc.
Decision Date1986-10-30
Product CodeEKM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GUTTA PERCHA is the device name listed in this FDA 510(k) record. The listed applicant is Endodent, Inc.. It received FDA 510(k) clearance on 1986-10-30 under 510(k) number K863411. 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 GUTTA PERCHA?

GUTTA PERCHA is a medical device that received FDA 510(k) clearance on 1986-10-30. The listed applicant is Endodent, Inc.. The 510(k) number is K863411.

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

GUTTA PERCHA received FDA 510(k) clearance on 1986-10-30, under 510(k) number K863411.

Who is the listed applicant for GUTTA PERCHA?

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

What is the FDA product code for GUTTA PERCHA?

The FDA product code for GUTTA PERCHA is EKM.

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 Endodent, 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.

K863638GUTTA PERCHA POINTSK830814POINT, PAPER ENDODONTIC

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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