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
97–120 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 11, 2026
Snorbliss® Anti-Snoring Device
K261251 · LRK
Endeavor Commerce, LLC
Dental · 56d
Cleared Jun 11, 2026
Rosetta SM, Rosetta SP
K260859 · EIH
Hass Corp.
Dental · 87d
Cleared Jun 11, 2026
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)
K254145 · NHA
Smart Denture Conversions, LLC
Dental · 171d
Cleared Jun 11, 2026
Fluoride Varnish (Type A,Type C)
K253052 · LBH
Nagy Oral Technology Qinhuangdao Co.,...
Dental · 262d
Cleared Jun 09, 2026
DESS Dental Smart Solutions
K260564 · NHA
Terrats Medical SL
Dental · 110d
Cleared Jun 03, 2026
BracePaste Prime Plus
K261840 · DYH
American Orthodontics
Dental · 1d
Cleared Jun 03, 2026
VSP System (Titanium Palatal Splint)
K261826 · DZJ
3D Systems, Inc.
Dental · 2d
Cleared Jun 03, 2026
SIC Abutments including CAD/CAM Solutions
K252904 · NHA
Sic Invent AG
Dental · 265d
Cleared Jun 02, 2026
DIAFIL
K261093 · EBF
DiaDent Group International
Dental · 61d
Cleared Jun 02, 2026
DB 4000 High Impact Denture Base
K260569 · EBI
Carbon, Inc.
Dental · 103d
Cleared May 29, 2026
LUNE PureHygiene
K260138 · GEX
Enamel Pure
Dental · 133d
Cleared May 21, 2026
MuCover (proposed name) Oral Wound Dressing
K253816 · OLR
MoleculeX Co., Ltd.
Dental · 174d
Cleared May 21, 2026
DCMhotbond zircon
K253191 · EIH
Dental Creativ Management GmbH
Dental · 237d
Cleared May 20, 2026
Elos Accurate® Denture Fixation System
K253774 · NHA
Elos Medtech Pinol A/S
Dental · 175d
Cleared May 19, 2026
DIAFIL Bulk FLOW (Economic Package)
K261071 · EBF
DiaDent Group International
Dental · 48d
Cleared May 19, 2026
OrthoEasy Pal
K260268 · OAT
Bernhard Förster GmbH (Bernhard...
Dental · 111d
Cleared May 19, 2026
SOGA Lasers therapy system family of Aurora handpiece (Aurora-S)
K253309 · NVK
Shenzhen Soga Technology Co., Ltd.
Dental · 232d
Cleared May 18, 2026
G-CEM UNIVERSAL
K254109 · EMA
GC America, Inc.
Dental · 150d
Cleared May 14, 2026
Dormiva Anti-Snoring Mouth Guard
K261134 · LRK
Koncept Innovators, Inc.
Dental · 37d
Cleared May 14, 2026
Any-Etch
K260485 · KLE
Mediclus Co., Ltd.
Dental · 90d
Cleared May 14, 2026
Bonalive Maxillofacial
K253883 · LYC
Bonalive , Ltd.
Dental · 161d
Cleared May 14, 2026
ET Healing Abutments
K253372 · NHA
Hiossen, Inc.
Dental · 226d
Cleared May 12, 2026
Promimic ZrP Surface Dental Implant
K252731 · DZE
Promimic AB
Dental · 257d
Cleared May 11, 2026
Dual Core
K260805 · EBF
Vericom Co., Ltd.
Dental · 60d