Dental Instruments - Cutting Instrument

FDA 510(k) K823326 · Miltex, Inc.

Substantially Equivalent

510(k) numberK823326

Submission

Device name
Dental Instruments - Cutting Instrument
Applicant
Miltex, Inc.
Mchenry, IL, US
Received
November 8, 1982
Decision date
November 24, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ELA – Instrument, Hand, Calculus Removal
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code ELA

510(k)DeviceApplicantDecision
K952363Opus Pacemakers (Models 4021, 4033, and 4034)ELA · Traditional Ela Medical, Inc.08/15/1995SE
K854168Travenol Disposable Dental Scalers/CurettesELA · Traditional Travenol Laboratories, S.A.03/13/1986SE
K801974Analytic Tech. Metal Point Heater #3001ELA · Traditional Analytic Technology11/12/1980SE

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Questions and answers

When was Dental Instruments - Cutting Instrument cleared by the FDA?

Dental Instruments - Cutting Instrument (K823326) received a 510(k) decision of Substantially Equivalent on November 24, 1982, 16 days after the submission was received.

What is the product code of K823326?

The FDA product code is ELA – Instrument, Hand, Calculus Removal, a Class I (low risk) device regulated under 21 CFR 872.4565.