Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

179 results for "Straumann USA"
25–48 of 179
Search insights Median review: 131d Cleared: 100% Top manufacturer: Institut Straumann AG Lead specialty: Dental
Cleared Dec 22, 2023
Anthogyr INTEGRAL Guided Surgery Cassettes
K233264 · KCT
Anthogyr
General Hospital · 84d
Cleared Oct 31, 2023
Neodent Implant System - GM Zygomatic Implant System
K232099 · DZE
JJGC Ind?stria e Com?rcio de...
Dental · 110d
Cleared Oct 16, 2023
Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
K230104 · DZE
Anthogyr
Dental · 276d
Cleared Sep 14, 2023
Straumann® BLC and TLC Implants
K230108 · DZE
Institut Straumann AG
Dental · 244d
Cleared Jul 14, 2023
Neodent Implant System - Zirconia Implant System
K222026 · NHA
Jjgc Industria E Comercio DE...
Dental · 368d
Cleared Jul 11, 2023
Anthogyr Surgical Cassettes
K230680 · KCT
Anthogyr
General Hospital · 120d
Cleared Jul 07, 2023
Complement Kit Cases
K230804 · KCT
JJGC Ind?stria e Com?rcio de...
General Hospital · 106d
Cleared Jun 23, 2023
Neodent Implant System - Helix Short Implant System
K223638 · DZE
Jjgc Industria E Comercio DE...
Dental · 200d
Cleared Jun 22, 2023
Straumann SLActive labeling changes
K223083 · DZE
Institut Straumann AG
Dental · 265d
Cleared May 15, 2023
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
K222836 · NHA
Institut Straumann AG
Dental · 237d
Cleared Apr 20, 2023
Neodent Implant System - Helix Short Surgical Kit Cases
K223662 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 135d
Cleared Sep 06, 2022
Neodent Implant System - GM Narrow Implant System
K220251 · DZE
Jjgc Industria E Comercio DE...
Dental · 218d
Cleared Jun 16, 2022
Straumann TLX Variobase C
K220878 · NHA
Institut Straumann AG
Dental · 83d
Cleared Jun 02, 2022
Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
K220751 · NHA
Institut Straumann AG
Dental · 79d
Cleared Apr 13, 2022
Neodent Implant System-Helix NGM Compact Surgical Kit Cases
K214051 · KCT
JJGC Ind?stria e Com?rcio de...
General Hospital · 107d
Cleared Apr 08, 2022
TLX SRAs and TLX Gold Abutments
K213063 · NHA
Institut Straumann AG
Dental · 197d
Cleared Jan 28, 2022
BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
K212533 · DZE
Institut Straumann AG
Dental · 170d
Cleared Oct 09, 2021
Straumann CARES P-Series CAD/CAM System
K203750 · NHA
Institut Straumann AG
Dental · 290d
Cleared Aug 13, 2021
Neodent Implant System - Zirconia Implant System
K210336 · DZE
Jjgc Industria E Comercio DE...
Dental · 189d
Cleared Aug 02, 2021
Neodent Implant System - Mini Abutment 60°
K203542 · NHA
Jjgc Industria E Comercio DE...
Dental · 242d
Cleared Jul 29, 2021
Straumann Surgical Cassettes
K203753 · KCT
Straumann USA, LLC
General Hospital · 218d
Cleared Jul 08, 2021
Straumann RidgeFit Implants
K211052 · DZE
Institut Straumann AG
Dental · 90d
Cleared Jul 06, 2021
NUVO CF Implant System
K203309 · DZE
JJGC Ind?stria e Com?rcio de...
Dental · 238d
Cleared Jun 23, 2021
Straumann CARES M-Series CAD/CAM System
K203456 · NHA
Institut Straumann AG
Dental · 212d