Dental Direkt GmbH is one of 470 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Dental Direkt GmbH - FDA 510(k) Cleared Devices
Recent clearances: DD Hybridlayer (multicolored zirconia), DD medical polymers (PMMA), DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
9
Total
9
Cleared
0
Denied
Dental Direkt GmbH has 9 FDA 510(k) cleared medical devices. Based in Spenge, DE.
Latest FDA clearance: Sep 2024. Active since 2015. Primary specialty: Dental.
Browse the FDA 510(k) cleared devices submitted by Dental Direkt GmbH Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Dental Direkt GmbH (Former Dental Direkt of Amerika Ug) as regulatory consultant.
FDA 510(k) Regulatory Record - Dental Direkt GmbH
9 devices
Cleared
Sep 06, 2024
DD Hybridlayer (multicolored zirconia)
Dental
95d
Cleared
Jun 23, 2023
DD medical polymers (PMMA)
Dental
128d
Cleared
Apr 25, 2023
DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
Dental
89d
Cleared
Jan 11, 2023
DD Solid Connect® CAD/CAM Abutments
Dental
1356d
Cleared
Apr 16, 2020
DD Contrast
Dental
115d
Cleared
Feb 14, 2019
DD cube ONE ML
Dental
55d
Cleared
Aug 01, 2017
DD cubeX2 HS
Dental
127d
Cleared
May 13, 2016
DD medical polymers
Dental
161d
Cleared
Mar 26, 2015
DD cubeX2
Dental
56d