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
1225–1248 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Nov 30, 2021
Sherlock
K212664 · NHA
Open Implants, LLC
Dental · 99d
Cleared Nov 30, 2021
Paltop Narrow Implant
K210117 · DZE
Paltop Advanced Dental Solutions, Ltd.
Dental · 315d
Cleared Nov 24, 2021
C-30 Crown Kit
K211345 · EBF
Perfect Fit Crowns, LLC
Dental · 205d
Cleared Nov 22, 2021
VITA Akzent LC
K211854 · EBD
Vita Zahnfabrik GmbH H Rauter & CO
Dental · 159d
Cleared Nov 18, 2021
FAICO Dental Implant System and CAD/CAM Abutments
K211871 · NHA
Faico Medical, LLC
Dental · 154d
Cleared Nov 18, 2021
Gemini 2 810+980 Soft Tissue Laser
K210350 · NVK
Azena Medical, LLC
Dental · 283d
Cleared Nov 17, 2021
BruxZir Esthetic
K213425 · EIH
Prismatik Dentalcraft, Inc.
Dental · 27d
Cleared Nov 15, 2021
DS Implants abutments provided with the EV connection
K213449 · NHA
Dentsply Sirona
Dental · 20d
Cleared Nov 15, 2021
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K212765 · EIH
Bloomden Bioceramics (Hunan) Co., Ltd.
Dental · 76d
Cleared Nov 12, 2021
NightGuard Flex
K212448 · MQC
Sprintray, Inc.
Dental · 99d
Cleared Nov 12, 2021
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K212259 · EIH
Zirdent New Material Co., Ltd.
Dental · 115d
Cleared Nov 08, 2021
Highspeed Airturbine Handpiece
K202371 · EFB
Beijing Dongbo Dental Handpiece Co.,...
Dental · 446d
Cleared Nov 04, 2021
Ortho Aligner System
K212496 · NXC
Ortho Lab Services, LLC
Dental · 87d
Cleared Nov 02, 2021
Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF,...
K210473 · EMA
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 258d
Cleared Nov 01, 2021
Alpha Dent Implants Dental Implants System
K210499 · DZE
Alpha Dent Implants GmbH
Dental · 252d
Cleared Oct 26, 2021
QuickAligners
K211537 · NXC
Oral Image, Inc.
Dental · 161d
Cleared Oct 26, 2021
EndSnorZ Sleep Appliance
K211069 · LRK
Prismatik Dentalcraft, Inc.
Dental · 197d
Cleared Oct 21, 2021
GR Splint Resin System
K211415 · MQC
Pro3dure Medical GmbH
Dental · 168d
Cleared Oct 20, 2021
S.I.N. Dental Implant System
K211921 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 121d
Cleared Oct 20, 2021
EQ-PEX
K210789 · LQY
Meta Systems Co., Ltd.
Dental · 218d
Cleared Oct 20, 2021
Multi-unit Abutment, Multi-unit Angled Abutment
K203808 · NHA
Megagen Implant Co., Ltd.
Dental · 296d
Cleared Oct 15, 2021
Magicore System
K212517 · DZE
Innobiosurg Co., Ltd.
Dental · 66d
Cleared Oct 15, 2021
Ortho MI System
K211992 · OAT
Osteonic Co., Ltd.
Dental · 109d
Cleared Oct 14, 2021
Vittra APS Unique
K210231 · EBF
Dentscare Ltda
Dental · 259d