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ERL

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Product code
ERL
Device name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device class
Class 2
21 CFR
21 CFR 874.4250
Medical specialty
Ear, Nose, Throat
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
91 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-07-03.

NumberDecision dateApplicantDevice nameSummary
K2432802025-07-03W&H Dentalwerk Buermoos GmbHPiezomed Pro (Piezomed Pro module M-PM100 incl. hand…PDF
K2339582024-03-14Zethon, Ltd.hekaDrillPDF

2 summaries are archived here for direct download.

Official FDA classification page: ERL
Classification and pathway per current FDA publications. Data from openFDA (CC0).