FDA-Device2024-02-28Class II
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
W&H DENTALWERK BUERMOOS GMBH
Hazard
1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Philippines, Sweden.
Affected count
160 pieces
Manufactured in
Ignaz Glaser Strase 53, 53 IGNAZ-GLASER-STRASSE, BUERMOOS, N/A, Austria
Products
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1168-2024Don't want to check this manually?
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