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FDA 510(k)

PROFLEX FLEXIBLE SCALER

K-Number: K821364 · 1982-05-28

ApplicantTeledyne Densco
Decision Date1982-05-28
Product CodeEHM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROFLEX FLEXIBLE SCALER is the device name listed in this FDA 510(k) record. The listed applicant is Teledyne Densco. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821364. The device is classified under product code EHM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFLEX FLEXIBLE SCALER?

PROFLEX FLEXIBLE SCALER is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is Teledyne Densco. The 510(k) number is K821364.

When did PROFLEX FLEXIBLE SCALER receive FDA 510(k) clearance?

PROFLEX FLEXIBLE SCALER received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821364.

Who is the listed applicant for PROFLEX FLEXIBLE SCALER?

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

What is the FDA product code for PROFLEX FLEXIBLE SCALER?

The FDA product code for PROFLEX FLEXIBLE SCALER is EHM.

Related Clinical Trials

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Other records listing Teledyne Densco 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.

K821686DENSCO PROPHY ANGLEK803155PROPHYLAXIS CUP.K780641DENTAL ROTARY CARBIDE BURS 76EJL

Related Devices (Code: EHM)

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.

K790598RUWA FINISHING STRIPSHowmedica Corp.

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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