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FDA 510(k)

ANTIBACTERIAL GUTTA PERCHA

K-Number: K971641 · 1997-07-21

ApplicantDr. Howard Martin, P.A.
Decision Date1997-07-21
Product CodeEKM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ANTIBACTERIAL GUTTA PERCHA is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Howard Martin, P.A.. It received FDA 510(k) clearance on 1997-07-21 under 510(k) number K971641. 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 ANTIBACTERIAL GUTTA PERCHA?

ANTIBACTERIAL GUTTA PERCHA is a medical device that received FDA 510(k) clearance on 1997-07-21. The listed applicant is Dr. Howard Martin, P.A.. The 510(k) number is K971641.

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

ANTIBACTERIAL GUTTA PERCHA received FDA 510(k) clearance on 1997-07-21, under 510(k) number K971641.

Who is the listed applicant for ANTIBACTERIAL GUTTA PERCHA?

The FDA 510(k) record lists Dr. Howard Martin, P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTIBACTERIAL GUTTA PERCHA?

The FDA product code for ANTIBACTERIAL 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 Dr. Howard Martin, P.A. 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.

K051573TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)K973636MCS-MEDICATED CANAL SEALER

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 TechnologiesK970134THERMAPREP PLUS OVENTulsa Dental Products, Ltd.

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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