FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,611 results
97–120 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Apr 06, 2026
GLOSSY COAT (15ML)
K254091 · EBD
YAMAHACHI DENTAL MFG., Co.
Dental · 108d
Cleared Apr 06, 2026
Light-curing Coloring Materials (ALCM)
K253036 · EBF
Aidite (Qinhuangdao) Technology Co.,...
Dental · 196d
Cleared Apr 06, 2026
ProSomnus RPMO2 OSA Device (RPMO2 OSA)
K252765 · PLC
Prosomnus Sleep Technologies
Dental · 220d
Cleared Apr 02, 2026
Leforte MMF System
K252246 · JEY
Jeil Medical Corporation
Dental · 258d
Cleared Mar 27, 2026
CyClean Cord
K254239 · MVL
SS GLOBAL
Dental · 88d
Cleared Mar 23, 2026
Adin Long Dental Implant System
K252031 · DZE
Adin Dental Implant Systems , Ltd.
Dental · 266d
Cleared Mar 20, 2026
Bifix Veneer LC, Bifix Veneer Try-In
K252606 · EMA
Voco GmbH
Dental · 214d
Cleared Mar 19, 2026
Dia-X Sil Bite
K254112 · ELW
DiaDent Group International
Dental · 90d
Cleared Mar 18, 2026
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
K260830 · LBH
Sangi Co, Ltd.
Dental · 5d
Cleared Mar 17, 2026
enCore Impression Material
K251926 · SHI
Encore Guards
Dental · 267d
Cleared Mar 16, 2026
ZENEX Implant System_Short (R-System)
K253334 · DZE
Izenimplant Co., Ltd.
Dental · 167d
Cleared Mar 11, 2026
Venus Diamond
K260783 · EBF
Kulzer, LLC
Dental · 1d
Cleared Mar 10, 2026
Varios Combi Pro2
K260773 · ELC
Nakanishi, Inc.
Dental · 1d
Cleared Mar 10, 2026
Gemini NOVA 810+980 Soft Tissue Laser
K260765 · NVK
Azena Medical, LLC
Dental · 1d
Cleared Mar 10, 2026
IPS e.max Zirconia
K253953 · EIH
Ivoclar Vivadent, Inc.
Dental · 90d
Cleared Mar 10, 2026
Straumann® BLC Implants - Indication Widening
K252168 · DZE
Institut Straumann AG
Dental · 243d
Cleared Mar 06, 2026
BONTREE PLUS
K251818 · LYC
Hudens Bio Co., Ltd.
Dental · 266d
Cleared Mar 05, 2026
Adhese 2
K252450 · KLE
Ivoclar Vivadent, Inc.
Dental · 213d
Cleared Mar 04, 2026
SureSmile Software
K253565 · PNN
Dentsply Sirona, Inc.
Dental · 107d
Cleared Mar 04, 2026
Dentis SQ-SL AXEL Fixture
K253493 · DZE
Dentis Co., Ltd.
Dental · 128d
Cleared Mar 04, 2026
Healing Abutment System
K251434 · NHA
Osstem Implant Co., Ltd.
Dental · 300d
Cleared Mar 03, 2026
Bond-PR™ Universal Adhesive
K260682 · KLE
Premier Dental Products Company
Dental · 1d
Cleared Mar 03, 2026
ZAFIRA®
K254245 · EBF
New Stetic, SA
Dental · 64d
Cleared Mar 03, 2026
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
K253845 · LRK
Ram.Shaw Pte. , Ltd.
Dental · 91d