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
1153–1176 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
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
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