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
6025–6048 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared May 16, 2002
STERNGOLD 66, MODEL #1180230
K021367 · EJS
Sterngold
Dental · 16d
Cleared May 16, 2002
SYNTHES (USA) AUTOMATED TACK DRIVER
K021382 · JEY
Synthes (Usa)
Dental · 14d
Cleared May 14, 2002
BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS
K013587 · KKO
Babies Best, Inc.
Dental · 196d
Cleared May 13, 2002
EVERSTICK ORTHO
K021126 · EBI
Stick Tech , Ltd.
Dental · 35d
Cleared May 13, 2002
AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
K021416 · ELW
Dentsply Intl.
Dental · 10d
Cleared May 10, 2002
NSI HEXED AND NON-HEXED IMPLANT SYSTEM
K020617 · DZE
Nsi
Dental · 74d
Cleared May 10, 2002
GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
K021258 · MCF
Germ Terminator Corporation
Dental · 21d
Cleared May 10, 2002
AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL
K021413 · ELW
Dentsply Intl.
Dental · 7d
Cleared May 08, 2002
AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
K021410 · ELW
Dentsply Intl.
Dental · 5d
Cleared May 07, 2002
HIGH SILVER CONVENTIONAL
K020452 · EJJ
Ab Ardent
Dental · 85d
Cleared May 07, 2002
OSSIFORM
K020720 · LYC
Unicare Biomedical, Inc.
Dental · 63d
Cleared May 03, 2002
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
K014068 · EBW
W&H Dentalwerk Buermoos GmbH
Dental · 144d
Cleared May 03, 2002
STARFLOW HV
K020760 · EBF
Danville Materials, Inc.
Dental · 57d
Cleared May 03, 2002
GC ELITE CEMENT 100
K021038 · EMA
GC America, Inc.
Dental · 32d
Cleared May 03, 2002
ACE HA SCREW DENTAL IMPLANT SYSTEM
K021244 · DZE
Ace Surgical Supply Co., Inc.
Dental · 14d
Cleared May 01, 2002
FRC POSTEC
K013802 · ELR
Ivoclar Vivadent, Inc.
Dental · 167d
Cleared May 01, 2002
SOLO ORTHO 3
K020502 · DYH
Sybron Dental Specialties, Inc.
Dental · 76d
Cleared May 01, 2002
GRIDLOCK 195 ADHESIVE
K020648 · DYH
Allodex Systems
Dental · 62d
Cleared Apr 26, 2002
GC FUJI ORTHO BAND PASTE PAK
K020578 · DYH
GC America, Inc.
Dental · 64d
Cleared Apr 24, 2002
AGC SPEZIALLEGIERUNG
K020347 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 79d
Cleared Apr 24, 2002
SIMPLICITY
K020570 · KLE
Apex Dental Materials, Inc.
Dental · 62d
Cleared Apr 23, 2002
SYNTHES TRANSLATING MAXILLARY DISTRACTOR
K020505 · JEY
Synthes (Usa)
Dental · 67d
Cleared Apr 22, 2002
BOND-3 ADHESIVE
K020499 · KLE
Jeneric/Pentron, Inc.
Dental · 67d
Cleared Apr 22, 2002
SONATA MICRO HYBRID COMPOSITE
K020555 · EBF
Pentron Laboratory Technologies
Dental · 61d