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FDA 510(k)

DENTAL INSTRUMENTS - CUTTING INSTRUMENT

K-Number: K823326 · 1982-11-24

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

Device Summary

DENTAL INSTRUMENTS - CUTTING INSTRUMENT 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 K823326. The device is classified under product code ELA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL INSTRUMENTS - CUTTING INSTRUMENT?

DENTAL INSTRUMENTS - CUTTING INSTRUMENT 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 K823326.

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

DENTAL INSTRUMENTS - CUTTING INSTRUMENT received FDA 510(k) clearance on 1982-11-24, under 510(k) number K823326.

Who is the listed applicant for DENTAL INSTRUMENTS - CUTTING INSTRUMENT?

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 - CUTTING INSTRUMENT?

The FDA product code for DENTAL INSTRUMENTS - CUTTING INSTRUMENT is ELA.

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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: ELA)

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.

K952363OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)Ela Medical, Inc.K854168TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTESTravenol Laboratories, S.A.K801974ANALYTIC TECH. METAL POINT HEATER #3001Analytic Technology

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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