510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161957Substantially Equivalent

W&H Implantmed SI-1015 incl. Accessories

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

K161957 is the FDA 510(k) clearance record for W&H Implantmed SI-1015 incl. Accessories, a class I device, cleared for W&H Dentalwerk Burmoos GmbH on under FDA product code EBW (Controller, Foot, Handpiece And Cord). FDA records list 5 510(k) clearances for W&H Dentalwerk Burmoos GmbH, from to . As of , FDA records show no recalls naming K161957.

Clearance record

Decision date
Received
(128 days to decision)
Product code
EBW Controller, Foot, Handpiece And Cord
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
W&H Dentalwerk Burmoos GmbH Ignaz-Glaser-Strabe 53, Buermoos, AT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EBW

Trailing 12 months
2 clearances under product code EBW in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EBW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260