W&H Implantmed SI-1015 incl. Accessories

FDA 510(k) K161957 · W&H Dentalwerk Burmoos GmbH

Substantially Equivalent

510(k) numberK161957

Submission

Device name
W&H Implantmed SI-1015 incl. Accessories
Applicant
W&H Dentalwerk Burmoos GmbH
Buermoos, AT
Received
July 18, 2016
Decision date
November 23, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EBW – Controller, Foot, Handpiece And Cord
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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Questions and answers

When was W&H Implantmed SI-1015 incl. Accessories cleared by the FDA?

W&H Implantmed SI-1015 incl. Accessories (K161957) received a 510(k) decision of Substantially Equivalent on November 23, 2016, 128 days after the submission was received.

What is the product code of K161957?

The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.