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FDA 510(k)

DENTAL INSTRUMENTS

K-Number: K823314 · 1982-11-24

ApplicantMiltex, Inc.
Decision Date1982-11-24
Product CodeEJL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Miltex, Inc.. It received FDA 510(k) clearance on 1982-11-24 under 510(k) number K823314. 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 INSTRUMENTS?

DENTAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1982-11-24. The listed applicant is Miltex, Inc.. The 510(k) number is K823314.

When did DENTAL INSTRUMENTS receive FDA 510(k) clearance?

DENTAL INSTRUMENTS received FDA 510(k) clearance on 1982-11-24, under 510(k) number K823314.

Who is the listed applicant for DENTAL INSTRUMENTS?

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

What is the FDA product code for DENTAL INSTRUMENTS?

The FDA product code for DENTAL INSTRUMENTS is EJL.

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Other records listing Miltex, 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.

K101653MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTESK092855MILTEX MEMBRANE TACK KITK083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTK072563MILTEX RIGID CONTAINER SYSTEMSK061033MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)K052018MILTEX LIGATING CLIP

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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 AbrasiviK923883DENTAL OR SURGICAL BURStratum Dental Technologies, Inc.

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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