510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213221Substantially Equivalent

AMADEO, M-UK1015 (incl. attachments and accessories)

W&H Dentalwerk Buermoss GmbH, Buermoos, AT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213221 is the FDA 510(k) clearance record for AMADEO, M-UK1015 (incl. attachments and accessories), a class II device, cleared for W&H Dentalwerk Buermoss GmbH on under FDA product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece). FDA records list 2 510(k) clearances for W&H Dentalwerk Buermoss GmbH, from to . As of , FDA records show no recalls naming K213221.

Clearance record

Decision date
Received
(239 days to decision)
Product code
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Regulation
21 CFR 874.4250
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
W&H Dentalwerk Buermoss GmbH Ignaz-Glaser-Strasse 53, Buermoos, AT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ERL

Trailing 12 months

FDA records hold no clearances under product code ERL in the trailing twelve months.

FDA records show no clearances under product code ERL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ERL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260