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FDA 510(k)

GUTTA PERCHA POINTS

K-Number: K830114 · 1983-03-01

ApplicantNorth Pacific Dental, Inc.
Decision Date1983-03-01
Product CodeEKM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GUTTA PERCHA POINTS is the device name listed in this FDA 510(k) record. The listed applicant is North Pacific Dental, Inc.. It received FDA 510(k) clearance on 1983-03-01 under 510(k) number K830114. 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 POINTS?

GUTTA PERCHA POINTS is a medical device that received FDA 510(k) clearance on 1983-03-01. The listed applicant is North Pacific Dental, Inc.. The 510(k) number is K830114.

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

GUTTA PERCHA POINTS received FDA 510(k) clearance on 1983-03-01, under 510(k) number K830114.

Who is the listed applicant for GUTTA PERCHA POINTS?

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

What is the FDA product code for GUTTA PERCHA POINTS?

The FDA product code for GUTTA PERCHA POINTS is EKM.

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Other records listing North Pacific Dental, 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.

K830113SEPTOPACKK830111SEPTOCALK830106UNICIDEK830117ENDOMETK830109CIMPATK830105VITATHYL

View all 11 devices →

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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