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
7489–7512 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jul 01, 1997
ACCU-PREP
K970484 · KOJ
Bisco, Inc.
Dental · 141d
Cleared Jun 30, 1997
ENDOSSEOUS DENTAL IMPLANT
K971578 · DZE
Straumann USA
Dental · 61d
Cleared Jun 30, 1997
HI DENSE TC
K971927 · EMA
Shofu Dental Corp.
Dental · 34d
Cleared Jun 30, 1997
RCT GEL ROOT CANAL THERAPY GEL
K972234 · EIC
Dentsply Intl.
Dental · 14d
Cleared Jun 27, 1997
ENCORE BOND
K971121 · KLE
Centrix, Inc.
Dental · 92d
Cleared Jun 27, 1997
OSTEOPOWER SYSTEM AND ACCESSORIES
K971692 · KMW
Osteomed Corp.
Dental · 51d
Cleared Jun 26, 1997
ENDO-SEAL
K971899 · KIF
Ultradent Products, Inc.
Dental · 35d
Cleared Jun 24, 1997
SMF TITANIUM (TI) ALLOY BONE SCREWS
K963546 · DZL
Synthes (Usa)
Dental · 292d
Cleared Jun 24, 1997
PLUSTRON ION TOOTHBRUSH SYSTEM
K971639 · MMD
Sas Group, Inc.
Dental · 53d
Cleared Jun 24, 1997
PERMALUTE, TRY-IN PASTE
K971898 · EBF
Ultradent Products, Inc.
Dental · 33d
Cleared Jun 24, 1997
SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR
K971987 · JEY
Synthes (Usa)
Dental · 26d
Cleared Jun 24, 1997
KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE
K972047 · MQN
KLS-Martin L.P.
Dental · 22d
Cleared Jun 23, 1997
EDOSSEOUS DENTAL IMPLANT
K970127 · DZE
Sulzer Calcitek, Inc.
Dental · 160d
Cleared Jun 23, 1997
SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM
K970752 · DZE
Sulzer Calcitek, Inc.
Dental · 112d
Cleared Jun 20, 1997
MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM
K971622 · KIF
Mpl Technologies, Inc.
Dental · 49d
Cleared Jun 20, 1997
NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION
K971774 · EFB
Nsk Nakanishi, Inc.
Dental · 38d
Cleared Jun 20, 1997
PLANMECA INTRACAM
K972033 · EIA
Planmeca Oy
Dental · 18d
Cleared Jun 19, 1997
INFECTION CONTROL CARTRIDGE
K964942 · EIA
Dentalpure Corp.
Dental · 191d
Cleared Jun 11, 1997
BIO-GIDE RESORBABLE BILAYER MEMBRANE
K960724 · NPK
Geistlich-Pharma
Dental · 475d
Cleared Jun 10, 1997
BREATH TAKER
K971887 · LCN
Hofa, LLC
Dental · 20d
Cleared Jun 04, 1997
TRI AUTO ZX
K970339 · EKX
J. Morita USA, Inc.
Dental · 126d
Cleared Jun 04, 1997
HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT
K970506 · EBZ
Benlioglu Dental Ithalat, Inc.
Dental · 114d
Cleared Jun 04, 1997
SERIES XE, SERIES SE, SERIES TE
K971350 · EGS
Micro-Mega Societe Anonyme
Dental · 55d
Cleared Jun 04, 1997
BENCHMARK-IV
K971575 · EJT
J.F. Jelenko & Co., Inc.
Dental · 58d