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
5113–5136 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Sep 23, 2005
ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS
K052245 · NJM
Lar Mfg., LLC
Dental · 37d
Cleared Sep 20, 2005
BLUEPHASE 16I
K051782 · EBZ
Ivoclar Vivadent, Inc.
Dental · 81d
Cleared Sep 20, 2005
MAXIMUS 3.0 AND OS IMPLANTS
K052419 · DZE
BioHorizons Implant Systems, Inc.
Dental · 18d
Cleared Sep 20, 2005
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
K052444 · JEY
Inion , Ltd.
Dental · 14d
Cleared Sep 19, 2005
O.A.S.I. SYSTEM
K051552 · DZE
Lancer Orthodontics, Inc.
Dental · 98d
Cleared Sep 19, 2005
FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502
K051750 · LBH
Ultradent Products, Inc.
Dental · 82d
Cleared Sep 16, 2005
MBCP
K051885 · LYC
Biomatlante
Dental · 66d
Cleared Sep 15, 2005
3I OSSEOTITE DENTAL IMPLANTS
K051461 · DZE
Implant Innovations, Inc.
Dental · 104d
Cleared Sep 09, 2005
PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL...
K051614 · DZE
Lifecore Biomedical, Inc.
Dental · 84d
Cleared Sep 07, 2005
EUGENONE
K051952 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 51d
Cleared Sep 06, 2005
IMPLANT HANDPIECES
K051661 · EKX
Sirona Dental Systems GmbH
Dental · 76d
Cleared Sep 06, 2005
PREMIER TEMPORARY CEMENT
K051866 · EMA
Premier Dental Products Co.
Dental · 57d
Cleared Sep 02, 2005
DOLOTENS DENTAL TM 1
K043373 · KZM
Neuromuscular Technologies, Inc.
Dental · 268d
Cleared Sep 02, 2005
INTERMEZZO IMPLANT SYSTEMS
K051018 · DZE
Megagen Co., Ltd.
Dental · 134d
Cleared Sep 02, 2005
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
K051507 · DZE
Blue Sky Bio, LLC
Dental · 87d
Cleared Sep 02, 2005
MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER
K051910 · ELC
D.B.I. America Corp.
Dental · 50d
Cleared Sep 02, 2005
CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
K052334 · ELC
Dentsply Intl.
Dental · 7d
Cleared Sep 01, 2005
SYNTHOGRAFT
K051091 · LYC
Bicon, Inc.
Dental · 126d
Cleared Sep 01, 2005
AVANA DENTAL IMPLANT SYSTEM
K051576 · DZE
Osstem Co., Ltd.
Dental · 79d
Cleared Aug 30, 2005
A-DEC SELF-CONTAINED WATER SYSTEM
K051657 · EIA
A-Dec, Inc.
Dental · 70d
Cleared Aug 26, 2005
FORTOSS VITAL BONE GRAFT SUBSTITUTE
K050170 · LYC
Biocomposites, Ltd.
Dental · 212d
Cleared Aug 22, 2005
RESORB-X SF
K051236 · JEY
KLS-Martin L.P.
Dental · 101d
Cleared Aug 22, 2005
GC FUJI FIL LC
K051427 · EMA
GC America, Inc.
Dental · 82d
Cleared Aug 22, 2005
MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM
K051946 · MQN
Medartis, Inc.
Dental · 35d