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
1–24 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Aug 28, 2026
X-Guide Surgical Navigation System
K253954 · QRY
X-Nav Technologies, LLC
Dental · 261d
Cleared Aug 27, 2026
Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
K262104 · LRK
Ram.Shaw Pte. , Ltd.
Dental · 65d
Cleared Aug 27, 2026
Glidewell™ Denture Base Resin
K261802 · EBI
Prismatik Dentalcraft, Inc.
Dental · 87d
Cleared Aug 25, 2026
Calcium Hydroxide Temporary Filling Material (KP-Cal)
K261514 · KIF
Guilin Kevin Peter Technology Co., Ltd.
Dental · 110d
Cleared Aug 25, 2026
iNOS intraoral biosensor
K254304 · PLC
Achaemenid, LLC
Dental · 237d
Cleared Aug 24, 2026
Guided Bone Regeneration System
K254286 · DZL
DentalMaster(Xiamen)Medical...
Dental · 236d
Cleared Aug 21, 2026
Any-Zircos
K262074 · EIH
Mediclus Co., Ltd.
Dental · 60d
Cleared Aug 19, 2026
ZEROS Dental Implant System
K260463 · DZE
Zeros Co., Ltd.
Dental · 188d
Cleared Aug 17, 2026
KLS Martin IPS Oral-Max Implants - MR Conditional
K260137 · JEY
KLS-Martin L.P.
Dental · 213d
Cleared Aug 13, 2026
UltraPrint Flexible Denture UV
K261626 · EBI
Guangzhou Heygears IMC., Inc.
Dental · 90d
Cleared Aug 13, 2026
Any-Cem
K254201 · EMA
Mediclus Co., Ltd.
Dental · 227d
Cleared Aug 07, 2026
PacTemp Automix NE
K261937 · EMA
The Belport Company Inc., DBA Gingi-Pak
Dental · 58d
Cleared Aug 07, 2026
Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)
K251544 · EIA
Lakong Medical Devices Co., Ltd.
Dental · 444d
Cleared Aug 06, 2026
Universal Base ASC Engaging
K253999 · NHA
Nobel Biocare AB
Dental · 234d
Cleared Aug 05, 2026
Ruthinium Disc
K261456 · POW
Dental Manufacturing S.P.A
Dental · 96d
Cleared Aug 05, 2026
NaturaJel™ Oral Wound Care Kit
K260120 · OLR
HCS Innovation, LLC
Dental · 202d
Cleared Jul 31, 2026
NanoCeram Resin
K262681 · EBI
3BFAB TEKNOLOJI A.S.
Dental · 1d
Cleared Jul 31, 2026
SnØreNegatØr
K261912 · LRK
DnB Innovations, LLC
Dental · 53d
Cleared Jul 31, 2026
Angled Screwdriver MED (M-SD090)
K253655 · DZI
W&H Dentalwerk B?rmoos GmbH
Dental · 253d
Cleared Jul 30, 2026
Obsidian® Press Over Zirconia
K262239 · EIH
Prismatik Dentalcraft, Inc.
Dental · 29d
Cleared Jul 29, 2026
Emanate Tray
K251908 · OLR
Emanate Biomedical
Dental · 404d
Cleared Jul 25, 2026
METICULY Patient-specific CMF solution
K253206 · JEY
Meticuly Co., Ltd.
Dental · 302d
Cleared Jul 21, 2026
One-Fil LC
K261728 · EJK
Mediclus Co., Ltd.
Dental · 56d
Cleared Jul 17, 2026
Dental Zirconia Blank & Coloring Liquid
K261046 · EIH
Hunan Qinghao Puzhong Technology Co.,...
Dental · 108d