FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,595 results
169–192 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Nov 20, 2025
UltraPrint-Dental Denture UV
K253324 · EBI
Guangzhou Heygears IMC., Inc.
Dental · 51d
Cleared Nov 18, 2025
Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant...
K252582 · NHA
Prismatik Dentalcraft, Inc.
Dental · 95d
Cleared Nov 07, 2025
MultiMatch Flow Chameleon AntiMicrobial Composite
K253513 · EBF
Premier Dental Products Company
Dental · 1d
Cleared Nov 07, 2025
Inion CPS 1.5 Baby Bioabsorbable Fixation System
K251441 · JEY
Inion OY
Dental · 182d
Cleared Nov 07, 2025
S.I.N. Tapered Pro Conical Zygoma Implant System
K251129 · DZE
S.I.N. Implant System Ltda
Dental · 210d
Cleared Nov 07, 2025
Primeprint Direct Aligner
K250739 · NXC
Dreve Dentamid GmbH
Dental · 241d
Cleared Nov 06, 2025
AIO Breathe
K252525 · LRK
Aiomega, LLC
Dental · 87d
Cleared Nov 06, 2025
MAGNABOND SE
K252469 · KLE
Dmp Dental Industry S.A.
Dental · 92d
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