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FDA 510(k)

DENTAL INSTRUMENTS - SCALERS

K-Number: K823319 · 1982-11-24

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

Device Summary

DENTAL INSTRUMENTS - SCALERS 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 K823319. The device is classified under product code EMS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL INSTRUMENTS - SCALERS?

DENTAL INSTRUMENTS - SCALERS 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 K823319.

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

DENTAL INSTRUMENTS - SCALERS received FDA 510(k) clearance on 1982-11-24, under 510(k) number K823319.

Who is the listed applicant for DENTAL INSTRUMENTS - SCALERS?

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 - SCALERS?

The FDA product code for DENTAL INSTRUMENTS - SCALERS is EMS.

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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: EMS)

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.

K931329DENTAL INSTRUMENTS CURETTE PERIODONTALMinnesota Prophy Power, Inc.K872091CURRETTES, ALVEOLAR (MOLT AND MILLER)Military Engineering, Inc.K870590CURETTE, PERIODONTAL, COLUMBIA UNIVERSITYMilitary Engineering, Inc.K841011ELEVATOR - VARIOUSPremier Dental Products Co.K834072INSTRUMENT, DENTALVenture Technology, Inc.K821789BEACH CURETTE NO. 2 AND NO. 3 T.G.Pacific Dental Corp.

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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