PROFLEX FLEXIBLE SCALER— 510(k) K821364

Substantially Equivalent

Teledyne Densco

FDA 510(k) clearance K821364 for PROFLEX FLEXIBLE SCALER, Substantially Equivalent on 1982-05-28. Applicant: Teledyne Densco. Device class: 1.

Clearance details

Applicant: Teledyne Densco
Product code: Code EHM
Device class: Class 1
Regulation: 21 CFR 872.6010
Advisory panel: Dental
Date received: 1982-05-07
Decision date: 1982-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code EHM

K790598 — RUWA FINISHING STRIPS1979-05-21

More clearances from Teledyne Densco

K821686 — DENSCO PROPHY ANGLE1982-06-25
K803155 — PROPHYLAXIS CUP.1981-01-08
K780641 — DENTAL ROTARY CARBIDE BURS 76EJL1978-04-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.