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
49–72 of 12,659
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