W&H Implantmed SI-1015 incl. Accessories
K-Number: K161957 · 2016-11-23
ApplicantW&H Dentalwerk Burmoos GmbH
Decision Date2016-11-23
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
W&H Implantmed SI-1015 incl. Accessories is a medical device manufactured by W&H Dentalwerk Burmoos GmbH. It received FDA 510(k) clearance on 2016-11-23 under approval number K161957. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the W&H Implantmed SI-1015 incl. Accessories?
W&H Implantmed SI-1015 incl. Accessories is a medical device that received FDA 510(k) clearance on 2016-11-23. It is manufactured by W&H Dentalwerk Burmoos GmbH. The 510(k) number is K161957.
When was W&H Implantmed SI-1015 incl. Accessories approved by the FDA?
W&H Implantmed SI-1015 incl. Accessories received FDA 510(k) clearance on 2016-11-23, under approval number K161957.
What company makes W&H Implantmed SI-1015 incl. Accessories?
W&H Implantmed SI-1015 incl. Accessories is manufactured by W&H Dentalwerk Burmoos GmbH.
What is the FDA product code for W&H Implantmed SI-1015 incl. Accessories?
The FDA product code for W&H Implantmed SI-1015 incl. Accessories is EBW.
Other Devices by W&H Dentalwerk Burmoos GmbH
Related Devices (Code: EBW)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.