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
1153–1176 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jan 07, 2022
EK Implants and Abutments System
K203360 · DZE
Hiossen, Inc.
Dental · 417d
Cleared Jan 05, 2022
Jplant
K211978 · DZE
Jj Medical Co., Ltd.
Dental · 194d
Cleared Dec 22, 2021
EdgePro
K213428 · NVK
Biolase, Inc.
Dental · 62d
Cleared Dec 22, 2021
Encore System
K213159 · ORY
Siesta Medical, Inc.
Dental · 85d
Cleared Dec 22, 2021
SleepRight Select-Comfort Dental Guard
K212767 · MQC
Splintek, Inc.
Dental · 113d
Cleared Dec 22, 2021
Neocis Guidance System (NGS) with Yomi Plan v2.0.1
K210711 · PLV
Neocis, Inc.
Dental · 287d
Cleared Dec 21, 2021
SURGmatic S15 L Pro
K213139 · EGS
Kavo Dental GmbH
Dental · 85d
Cleared Dec 21, 2021
Vision
K212770 · PNN
Softsmile, Inc.
Dental · 112d
Cleared Dec 21, 2021
BellaTek Encode Emergence Healing Abutments
K212730 · NHA
Biomet 3i, LLC
Dental · 113d
Cleared Dec 21, 2021
N1 TiUltra TCC Implant System
K211109 · DZE
Nobel Biocare Services AG
Dental · 251d
Cleared Dec 21, 2021
TRI-matrix Implant Line
K203660 · DZE
Tri Dental Implants Int. AG
Dental · 371d
Cleared Dec 19, 2021
ATOZ Mini-Screw
K210559 · OAT
Mk Meditech, Inc.
Dental · 297d
Cleared Dec 17, 2021
Cordless Prophy System, Model: i-Polish
K211531 · EKX
Guilin Woodpecker Medical Instrument...
Dental · 214d
Cleared Dec 16, 2021
ArchForm Orthodontic Software System
K213916 · PNN
Archform, Inc.
Dental · 1d
Cleared Dec 14, 2021
DESS Dental Implants
K212538 · DZE
Terrats Medical SL
Dental · 124d
Cleared Dec 13, 2021
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
K212706 · OBR
Splintek, Inc.
Dental · 109d
Cleared Dec 10, 2021
DESS Dental Smart Solutions
K212577 · NHA
Terrats Medical SL
Dental · 116d
Cleared Dec 10, 2021
Dental Scaler and Air Polisher
K203615 · ELC
Guilin Woodpecker Medical Instrument...
Dental · 365d
Cleared Dec 09, 2021
VOCO Retraction Paste
K213149 · MVL
Voco GmbH
Dental · 73d
Cleared Dec 08, 2021
Injectable Root Canal Bioceramic Sealer
K212983 · KIF
Beijing C-Root Dental Medical Devices...
Dental · 82d
Cleared Dec 08, 2021
C&B 5.0 Hybrid
K210817 · EBG
Arum Dentistry Co., Ltd.
Dental · 265d
Cleared Dec 06, 2021
LUXEN CL Dental Liquid
K212548 · EIH
Dentalmax Co., Ltd.
Dental · 115d
Cleared Dec 06, 2021
3Delta Crown
K211804 · EBF
Deltamed GmbH
Dental · 178d
Cleared Dec 02, 2021
PS System
K211721 · NYL
Inter-Med, Inc.
Dental · 181d