A-Silicone for Bite Registration
K-Number: K201684 · 2020-09-24
Decision Date2020-09-24
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
A-Silicone for Bite Registration is a medical device manufactured by Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2020-09-24 under approval number K201684. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the A-Silicone for Bite Registration?
A-Silicone for Bite Registration is a medical device that received FDA 510(k) clearance on 2020-09-24. It is manufactured by Shandong Huge Dental Material Corporation. The 510(k) number is K201684.
When was A-Silicone for Bite Registration approved by the FDA?
A-Silicone for Bite Registration received FDA 510(k) clearance on 2020-09-24, under approval number K201684.
What company makes A-Silicone for Bite Registration?
A-Silicone for Bite Registration is manufactured by Shandong Huge Dental Material Corporation.
What is the FDA product code for A-Silicone for Bite Registration?
The FDA product code for A-Silicone for Bite Registration is ELW.
Other Devices by Shandong Huge Dental Material Corporation
Related Devices (Code: ELW)
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.