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
5305–5328 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Dec 15, 2004
TORPICALGIN
K043131 · ELW
Zhermack S.P.A.
Dental · 33d
Cleared Dec 14, 2004
EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON...
K040671 · EJI
Anthogyr
Dental · 274d
Cleared Dec 14, 2004
SYSTEMP.C&B PLUS
K042820 · EBG
Ivoclar Vivadent, Inc.
Dental · 63d
Cleared Dec 14, 2004
SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K043190 · NHA
Innova Life Sciences Corp.
Dental · 27d
Cleared Dec 08, 2004
TUF LINK SILICONE RELINER
K042931 · EBI
Dentatus USA , Ltd.
Dental · 47d
Cleared Dec 07, 2004
RIVA SILVER
K042452 · EMA
Southern Dental Industries, Inc.
Dental · 88d
Cleared Dec 06, 2004
OSTIM
K030052 · LYC
Heraeus Kulzer, Inc.
Dental · 700d
Cleared Dec 06, 2004
ESTENIA C&B
K042929 · EBF
Kuraray Medical Kurashiki Plant
Dental · 45d
Cleared Dec 03, 2004
CERASYS - ZR
K042548 · EIH
Cerasys, Inc.
Dental · 74d
Cleared Dec 03, 2004
CORRECT DENTAL IMPRESSION MATERIAL
K042860 · ELW
Handae Chemical Co., Ltd.
Dental · 49d
Cleared Dec 01, 2004
COSMEDENT PIT & FISSURE SEALANT
K042823 · EBC
Cosmedent, Inc.
Dental · 50d
Cleared Dec 01, 2004
OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700
K042828 · EKR
Young O/S, LLC
Dental · 50d
Cleared Nov 26, 2004
CLEARFIL TRI-S BOND
K042913 · KLE
Kuraray Medical, Inc.
Dental · 36d
Cleared Nov 24, 2004
X-2 IMPLANT ABUTMENT
K042466 · NHA
Zest Anchors, Inc.
Dental · 72d
Cleared Nov 24, 2004
ADSEAL ROOT CANAL SEALER
K042769 · KIF
Meta Biomed Co., Ltd.
Dental · 50d
Cleared Nov 24, 2004
QUADRANT UNIT-1-BOND
K042806 · KLE
Cavex Holland BV
Dental · 43d
Cleared Nov 23, 2004
BICONITE SURFACE TREATMENT
K031568 · DZE
Bicon, Inc.
Dental · 553d
Cleared Nov 23, 2004
RONDOFLEX PLUS 360
K042872 · KOJ
Kavo America Corporation
Dental · 36d
Cleared Nov 23, 2004
MODIFICATION TO SYNTHES CRANIAL PLATES
K042987 · JEY
Synthes (Usa)
Dental · 25d
Cleared Nov 22, 2004
VIZILITE-BLUE ORAL EXAM KIT
K033033 · EAZ
Trylon Corp.
Dental · 423d
Cleared Nov 22, 2004
S&C-SELF ETCH PR-BOND
K042614 · KLE
S & C Polymer GmbH
Dental · 59d
Cleared Nov 22, 2004
FRC POSTEC PLUS
K042848 · ELR
Ivoclar Vivadent, Inc.
Dental · 38d
Cleared Nov 18, 2004
GRADIA DIRECT LOFLO
K042348 · EBF
GC America, Inc.
Dental · 80d
Cleared Nov 18, 2004
SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM
K042365 · JEY
Synthes (Usa)
Dental · 79d