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
25–48 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Sep 30, 2026
Elos Accurate Hybrid Base
K261327 · NHA
Elos Medtech Pinol A/S
Dental · 161d
Cleared Sep 29, 2026
THERMEO® I MSI
K260031 · MQC
Pro3dure Medical GmbH
Dental · 266d
Cleared Sep 25, 2026
EsTemp Implant
K262983 · EMA
Spident Co., Ltd.
Dental · 29d
Cleared Sep 25, 2026
Invisalign System
K262196 · PNN
Align Technology, Inc.
Dental · 88d
Cleared Sep 25, 2026
REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)
K254210 · NPM
Hyundai Bioland Co., Ltd.
Dental · 270d
Cleared Sep 24, 2026
MPa Max adhesive
K262252 · KLE
Den-Mat Holdings, LLC
Dental · 84d
Cleared Sep 23, 2026
Cemented Plus Abutment
K262207 · NHA
Unidental Co., Ltd.
Dental · 85d
Cleared Sep 23, 2026
DIAMED Handpiece
K262144 · EFB
SETAGAYA SEIKI Co., Ltd.
Dental · 90d
Cleared Sep 21, 2026
Core·it Dual
K262982 · EBF
Spident Co., Ltd.
Dental · 25d
Cleared Sep 21, 2026
BellaTek Bars
K260940 · NHA
ZimVie US Corp, LLC
Dental · 185d
Cleared Sep 18, 2026
Dental Diode Laser Device (Laser-Pen)
K261047 · GEX
Guilin Kevin Peter Technology Co., Ltd.
Dental · 171d
Cleared Sep 17, 2026
Hygienic Protective Bite Cover (2207-010-50)
K262073 · PEM
D?rr Dental SE
Dental · 87d
Cleared Sep 17, 2026
TriActive Dental Implant System
K261392 · DZE
Paragon Implant Mfg., LLC
Dental · 141d
Cleared Sep 16, 2026
Mouth Guard
K262559 · OBR
ChangSha ChuangDuoLe E-Commerce Co.,...
Dental · 54d
Cleared Sep 16, 2026
ClearClub Impression Material
K261888 · SHI
ClearClub
Dental · 103d
Cleared Sep 16, 2026
Dia-X Sil Light Body
K254152 · ELW
DiaDent Group International
Dental · 268d
Cleared Sep 16, 2026
Dia-X Sil Heavy Body
K254142 · ELW
DiaDent Group International
Dental · 268d
Cleared Sep 11, 2026
Vioseal X
K262050 · KIF
Spident Co., Ltd.
Dental · 85d
Cleared Sep 10, 2026
Cerasmart Forte
K262202 · EBF
GC America, Inc.
Dental · 73d
Cleared Sep 10, 2026
Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)
K254009 · SJH
Lakong Medical Devices Co., Ltd.
Dental · 269d
Cleared Sep 08, 2026
Reusable SmartPeg
K261987 · EKX
Osstell AB
Dental · 88d
Cleared Sep 08, 2026
Dental Barriers and Sleeves (AB0006)
K261956 · PEM
ANI Co., Ltd.
Dental · 89d
Cleared Sep 04, 2026
NeoPEX™ Pre-Mixed Obturation Paste
K253909 · KIF
NuSmile, Ltd.
Dental · 270d
Cleared Sep 03, 2026
Profisil Free
K262243 · LBH
Kettenbach GmbH & Co. KG
Dental · 64d