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
97–120 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
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
Cleared Mar 02, 2026
UltraPrint-Dental Hard Splint UV
K253798 · MQC
Guangzhou Heygears IMC., Inc.
Dental · 94d
Cleared Mar 02, 2026
“FLNT Base” and “FLNT Temp”
K253380 · EBG
Liaoning Upcera Co., Ltd.
Dental · 153d
Cleared Mar 02, 2026
Myosa (S1H, S1, S2, S3, S1M, S2M)
K252531 · LRK
Myofunctional Research Co.
Dental · 202d
Cleared Feb 27, 2026
One-Stop
K253797 · MVL
Mediclus Co., Ltd.
Dental · 91d
Cleared Feb 27, 2026
Allday Moisturizing Rinse
K253778 · LFD
Elevate Oral Care
Dental · 93d
Cleared Feb 26, 2026
Owl Night Guard
K253641 · OBR
Owl Dental Lab, Inc.
Dental · 99d
Cleared Feb 25, 2026
Remi Impression Material
K251724 · SHI
Grindguard, Inc.
Dental · 266d
Cleared Feb 23, 2026
VITA VMLC Primer
K251587 · KLE
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
Dental · 276d
Cleared Feb 18, 2026
Nobel Biocare S Series Implants
K252197 · DZE
Nobel Biocare AB
Dental · 219d
Cleared Feb 10, 2026
Solidex® Ti-Links and Screws
K251515 · NHA
CreoDent Hudson Valley
Dental · 270d
Cleared Feb 03, 2026
ZSmile System
K253282 · NXC
Dror Orthodesign , Ltd.
Dental · 127d
Cleared Feb 02, 2026
BIORES Dental Implant System
K252286 · DZE
Chengdu Besmile Medical Technology...
Dental · 194d
Cleared Jan 30, 2026
BruxZir® Shaded 16 PLUS
K254283 · EIH
Prismatik Dentalcraft, Inc.
Dental · 30d
Cleared Jan 30, 2026
Motor Handpiece and Control Unit (SDI10)
K251407 · EBW
Saeshin Precision Co., Ltd.
Dental · 269d
Cleared Jan 29, 2026
EK MULTI ANGLED 30 ABUTMENT
K251427 · NHA
Hiossen, Inc.
Dental · 266d
Cleared Jan 29, 2026
Multi-Unit DAS System
K243732 · NHA
Talladium Espa?a, SL
Dental · 421d