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FDA 510(k)

SILICONT BUR BLOCK

K-Number: K921406 · 1992-04-28

ApplicantInnovators, Inc.
Decision Date1992-04-28
Product CodeEJL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILICONT BUR BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Innovators, Inc.. It received FDA 510(k) clearance on 1992-04-28 under 510(k) number K921406. 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 SILICONT BUR BLOCK?

SILICONT BUR BLOCK is a medical device that received FDA 510(k) clearance on 1992-04-28. The listed applicant is Innovators, Inc.. The 510(k) number is K921406.

When did SILICONT BUR BLOCK receive FDA 510(k) clearance?

SILICONT BUR BLOCK received FDA 510(k) clearance on 1992-04-28, under 510(k) number K921406.

Who is the listed applicant for SILICONT BUR BLOCK?

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

What is the FDA product code for SILICONT BUR BLOCK?

The FDA product code for SILICONT BUR BLOCK is EJL.

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Other records listing Innovators, 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.

K921355WINGMASTERK921354BLUNT TIP IRRIGATION NEEDLESK844351OPTI-LITEK830042E-Z JECTORK790984KLIP-LITE

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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