SAVE GBR
K-Number: K222367 · 2023-03-23
ApplicantDentis Co., Ltd.
Decision Date2023-03-23
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SAVE GBR is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2023-03-23 under approval number K222367. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SAVE GBR?
SAVE GBR is a medical device that received FDA 510(k) clearance on 2023-03-23. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K222367.
When was SAVE GBR approved by the FDA?
SAVE GBR received FDA 510(k) clearance on 2023-03-23, under approval number K222367.
What company makes SAVE GBR?
SAVE GBR is manufactured by Dentis Co., Ltd..
What is the FDA product code for SAVE GBR?
The FDA product code for SAVE GBR is DZL.
Other Devices by Dentis Co., Ltd.
Related Devices (Code: DZL)
K151540MC BIO Supertack Tack 3mm, 4mm and 5mmEli-Ka Technologies
K171831Intra-Lock Bone Fixation SystemIntra-Lock International, Inc.
K161857Salvin Tenting Screw SystemSalvin Dental Specialties
K160991Neo GBR SystemNeobiotech Co., Ltd.
K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.
K181854OssBuilder SystemOsstem Implant Co., Ltd.
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.