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

Filters: Dental ×
12,659 results
625–648 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared May 10, 2024
Bioceramic Root Repair Material (C-Root BP)
K240365 · KIF
Beijing C-Root Dental Medical Devices...
Dental · 94d
Cleared May 09, 2024
Customized Abutment
K234112 · NHA
Arum Dentistry Co., Ltd.
Dental · 134d
Cleared May 09, 2024
Dental Barrier and Sleeves
K233918 · PEM
Yongqing Huaguan Dental Instruments...
Dental · 148d
Cleared May 09, 2024
Hushd Pro Avera
K232025 · LRK
Good Sleep CO Pte , Ltd.
Dental · 307d
Cleared May 07, 2024
CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System
K234018 · NHA
Dentsply Sirona
Dental · 139d
Cleared May 03, 2024
EMA 3D
K232735 · LRK
Ema Sleep Incorporated
Dental · 239d
Cleared May 02, 2024
Neodent Implant System – Custom Abutments
K233857 · NHA
JJGC Ind?stria e Com?rcio de...
Dental · 149d
Cleared May 01, 2024
BruxZir® Esthetic
K240882 · EIH
Prismatik Dentalcraft, Inc.
Dental · 30d
Cleared May 01, 2024
Soft Tissue Augmentation Resorbable Matrix
K233203 · NPL
Collagen Matrix, Inc.
Dental · 216d
Cleared May 01, 2024
SmarTooth
K231722 · NBL
Smartooth Co., Ltd.
Dental · 323d
Cleared Apr 30, 2024
Dental Implants and Abutments
K233231 · DZE
Ditron Dental, Ltd.
Dental · 215d
Cleared Apr 30, 2024
High Speed Air Turbine Handpiece...
K233122 · EFB
Litu Tech , Ltd.
Dental · 216d
Cleared Apr 30, 2024
METICULY Patient-specific titanium maxillofacial mesh implant
K232889 · JEY
Meticuly Co., Ltd.
Dental · 225d
Cleared Apr 30, 2024
Protective Cap
K232528 · NHA
Neobiotech Co., Ltd.
Dental · 253d
Cleared Apr 26, 2024
NB Mini Implant System
K240091 · DZE
Arum Dentistry Co., Ltd.
Dental · 105d
Cleared Apr 25, 2024
Air Motor (Model name: FX204 M4)
K233308 · EFB
Nakanishi, Inc.
Dental · 209d
Cleared Apr 25, 2024
Temporis, Irix Plus
K231142 · EBF
Dws S.R.L.
Dental · 370d
Cleared Apr 24, 2024
DESS Dental Smart Solutions
K240208 · NHA
Terrats Medical SL
Dental · 90d
Cleared Apr 19, 2024
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
K240508 · LFD
Laclede, Inc.
Dental · 58d
Cleared Apr 18, 2024
Difiney Anti Snoring Device
K233850 · LRK
Fissiontech, LLC
Dental · 135d
Cleared Apr 17, 2024
Goyo Mouthpiece S
K232238 · OBR
Dimedikorea
Dental · 264d
Cleared Apr 15, 2024
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM...
K223113 · NHA
Medentika GmbH
Dental · 560d
Cleared Apr 12, 2024
UltraThineer Zirconia Slurry (5Y-B)
K240419 · EIH
Boston Micro Fabrication
Dental · 59d
Cleared Apr 11, 2024
Ni2 Implant System
K221847 · DZE
Newton Implant Systems, Inc.
Dental · 657d