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
4729–4752 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Mar 02, 2007
OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM
K063792 · MQN
Osteomed LP
Dental · 70d
Cleared Mar 02, 2007
APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W
K070373 · EBZ
Apoza Enterprise Co., Ltd.
Dental · 22d
Cleared Mar 01, 2007
CREATION CP-ZI PORCELAIN
K070114 · EIH
Jensen Industries, Inc.
Dental · 48d
Cleared Feb 28, 2007
ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI
K062197 · NHA
Atlantis Components, Inc.
Dental · 211d
Cleared Feb 27, 2007
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
K062789 · JEY
Synthes (Usa)
Dental · 162d
Cleared Feb 27, 2007
ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP,...
K063592 · NHA
Nobel Biocare AB
Dental · 85d
Cleared Feb 26, 2007
GC FUJI IX GP EXTRA
K070319 · EMA
GC America, Inc.
Dental · 24d
Cleared Feb 23, 2007
CERTAIN PREVAIL DENTAL IMPLANT
K061629 · DZE
Implant Innovations, Inc.
Dental · 256d
Cleared Feb 22, 2007
NANOTITE DENTAL IMPLANTS
K062432 · DZE
Implant Innovations, Inc.
Dental · 185d
Cleared Feb 22, 2007
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL
K063596 · LYC
Novabone Products, LLC
Dental · 80d
Cleared Feb 20, 2007
BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101
K063704 · EEG
Beks Incorporated
Dental · 69d
Cleared Feb 16, 2007
BETA-POWDER
K063236 · KOJ
Brainbase Corporation
Dental · 114d
Cleared Feb 16, 2007
ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16
K063523 · DZE
Zimmer Dental, Inc.
Dental · 86d
Cleared Feb 16, 2007
DOWN PAK
K070246 · EKM
Endo Twinn B.V.
Dental · 22d
Cleared Feb 14, 2007
EXCEL CONTRA ANGLE HANDPIECE
K061897 · EGS
Orthosource, Inc.
Dental · 226d
Cleared Feb 14, 2007
ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT
K062069 · NHA
Atlantis Components, Inc.
Dental · 208d
Cleared Feb 12, 2007
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM
K061252 · DYH
Primus Consulting
Dental · 284d
Cleared Feb 12, 2007
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K063549 · LYC
Novabone Products, LLC
Dental · 80d
Cleared Feb 12, 2007
PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
K070287 · EBA
Photonic Optische Gerate GmbH & Cokg
Dental · 14d
Cleared Feb 09, 2007
LORENZ ORTHODONTIC ANCHORAGE SYSTEM
K063386 · OAT
Walter Lorenz Surgical, Inc.
Dental · 93d
Cleared Feb 09, 2007
CLEARFIL MAJESTY POSTERIOR
K063595 · EBF
Kuraray America, Inc.
Dental · 67d
Cleared Feb 08, 2007
MICROLUX TRANSILLUMINATOR
K062961 · NTK
Addent, Inc.
Dental · 132d
Cleared Feb 08, 2007
KAVO EVEREST C-TEMP
K063624 · EBG
Kavo America
Dental · 64d
Cleared Feb 08, 2007
DURAFLEX
K063626 · EBI
Cosmetic Dental Materials, Inc.
Dental · 64d