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FDA 510(k)

DENTAL OR SURGICAL BUR

K-Number: K923883 · 1993-07-27

ApplicantStratum Dental Technologies, Inc.
Decision Date1993-07-27
Product CodeEJL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL OR SURGICAL BUR is the device name listed in this FDA 510(k) record. The listed applicant is Stratum Dental Technologies, Inc.. It received FDA 510(k) clearance on 1993-07-27 under 510(k) number K923883. 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 DENTAL OR SURGICAL BUR?

DENTAL OR SURGICAL BUR is a medical device that received FDA 510(k) clearance on 1993-07-27. The listed applicant is Stratum Dental Technologies, Inc.. The 510(k) number is K923883.

When did DENTAL OR SURGICAL BUR receive FDA 510(k) clearance?

DENTAL OR SURGICAL BUR received FDA 510(k) clearance on 1993-07-27, under 510(k) number K923883.

Who is the listed applicant for DENTAL OR SURGICAL BUR?

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

What is the FDA product code for DENTAL OR SURGICAL BUR?

The FDA product code for DENTAL OR SURGICAL BUR is EJL.

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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 AbrasiviK921406SILICONT BUR BLOCKInnovators, 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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