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
241–264 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Nov 03, 2025
NightGuard Aire Max
K252698 · LRK
Nightguard Express, LLC
Dental · 68d
Cleared Nov 03, 2025
Midmark Dental Delivery System
K251626 · EIA
Midmark Corporation
Dental · 159d
Cleared Oct 31, 2025
Hydro Print Premium Fast Set - 454g (1lb) (052037)
K253501 · ELW
Vigodent Ind?stria E Comercio Ltda
Dental · 1d
Cleared Oct 31, 2025
DESS Dental Smart Solutions
K251547 · NHA
Terrats Medical SL
Dental · 163d
Cleared Oct 30, 2025
Freeprint® denture flex
K252430 · EBI
Detax GmbH
Dental · 90d
Cleared Oct 30, 2025
GEN5 and GEN5+ Dental Implant System
K251938 · DZE
Paragon Implant Mfg., LLC
Dental · 128d
Cleared Oct 29, 2025
Difiney Advanced Anti Snoring Device 4.0
K253355 · LRK
Fissiontech, LLC
Dental · 29d
Cleared Oct 28, 2025
Yomi S Robotic System
K252376 · PLV
Neocis, Inc.
Dental · 90d
Cleared Oct 28, 2025
ZIRCONOMER P
K252165 · EMA
Shofu Dental Corporation
Dental · 110d
Cleared Oct 24, 2025
Hushd Pro Z-Link
K251784 · LRK
Good Sleep CO Pte , Ltd.
Dental · 135d
Cleared Oct 23, 2025
Invisalign® Palatal Expander System
K252931 · NXC
Align Technology, Inc.
Dental · 38d
Cleared Oct 23, 2025
Silatrix Oral Gel
K252425 · OLR
Sa3, LLC
Dental · 83d
Cleared Oct 23, 2025
DESS® Dental Smart Solutions
K252384 · NHA
Terrats Medical SL
Dental · 84d
Cleared Oct 22, 2025
Mandibular Advancement Device L07
K251628 · LRK
Dcstar, Inc.
Dental · 147d
Cleared Oct 17, 2025
S.I.N. Dental Implant System
K252266 · NHA
S.I.N. Implant System Ltda
Dental · 88d
Cleared Oct 17, 2025
Remi Custom Night Guard
K251778 · OBR
Remi
Dental · 129d
Cleared Oct 17, 2025
Adin Customized Abutments
K250178 · NHA
Adin Dental Implant Systems , Ltd.
Dental · 268d
Cleared Oct 16, 2025
Alpha Endo Handpiece (Alpha Endo)
K252223 · EKX
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Dental · 92d
Cleared Oct 16, 2025
Elos Accurate Hybrid Base
K251497 · NHA
Elos Medtech Pinol A/S
Dental · 154d
Cleared Oct 16, 2025
MateLaser Medical Diode Laser Systems (ML-DLS-30)
K250731 · NVK
Matelaser, Inc.
Dental · 219d
Cleared Oct 15, 2025
LOCATOR® Angled Abutment
K252944 · NHA
Zest Anchors, LLC
Dental · 30d
Cleared Oct 15, 2025
Bonafix Implant Abutments
K251294 · NHA
Zentek Medical, LLC
Dental · 173d
Cleared Oct 14, 2025
Demi Pro
K253461 · EBZ
Meta Systems Co., Ltd.
Dental · 7d
Cleared Oct 10, 2025
Yomi Robotic System
K251835 · PLV
Neocis, Inc.
Dental · 116d