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FDA 510(k)

BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL

K-Number: K842720 · 1985-05-21

ApplicantPenn-Med Technology, Inc.
Decision Date1985-05-21
Product CodeEJL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL is the device name listed in this FDA 510(k) record. The listed applicant is Penn-Med Technology, Inc.. It received FDA 510(k) clearance on 1985-05-21 under 510(k) number K842720. The device is classified under product code EJL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL?

BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL is a medical device that received FDA 510(k) clearance on 1985-05-21. The listed applicant is Penn-Med Technology, Inc.. The 510(k) number is K842720.

When did BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL receive FDA 510(k) clearance?

BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL received FDA 510(k) clearance on 1985-05-21, under 510(k) number K842720.

Who is the listed applicant for BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL?

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

What is the FDA product code for BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL?

The FDA product code for BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL is EJL.

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Other records listing Penn-Med Technology, 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.

K843049CURING LIGHT

Related Devices (Code: EJL)

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.

K080687SMARTBURSS.S. White Burs, Inc.K071352CERADRILLGebr. Brasseler GmbH & Co. KGK061383BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPSB.T.I. Biotechnology Institute, Sl.K943273TRI HAWK BUR, FG BURTri Hawk Corp.K926205MONOSTERYLUtensili Super AbrasiviK923883DENTAL OR SURGICAL BURStratum Dental Technologies, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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