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
7609–7632 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Feb 10, 1997
WHITE CORE
K964931 · EBF
Bisco, Inc.
Dental · 62d
Cleared Feb 10, 1997
ROUND DENTAL BUR
K964944 · DZE
Steri-Oss, Inc.
Dental · 62d
Cleared Feb 10, 1997
TEMPFIL C&B
K964981 · EBG
Sybron Dental Specialties, Inc.
Dental · 60d
Cleared Feb 10, 1997
PFINGST PRESSURE PASTE
K965026 · EFH
Pfingst & Co., Inc.
Dental · 55d
Cleared Feb 05, 1997
DENTINSENSE
K964735 · KLE
Centrix, Inc.
Dental · 72d
Cleared Feb 04, 1997
TCB TEMPORARY CROWN AND BRIDGE MATERIAL
K964691 · EBG
Scican
Dental · 74d
Cleared Jan 31, 1997
ULTRA-ETCH STAT
K965060 · EBF
Ultradent Products, Inc.
Dental · 44d
Cleared Jan 24, 1997
TAP
K964516 · LRK
Nellcor Puritan Bennett, Inc.
Dental · 80d
Cleared Jan 24, 1997
VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE
K964649 · JEY
Howmedica Leibinger, Inc.
Dental · 65d
Cleared Jan 23, 1997
TONY RISO 25/30 MULTIFUNCTION SCALER
K964320 · ELC
Tony Riso Co., Inc.
Dental · 86d
Cleared Jan 22, 1997
SAFETY INJECTION SYSTEM
K962999 · EJI
Integritech, Inc.
Dental · 173d
Cleared Jan 22, 1997
DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED
K963548 · EIA
Mrlb Intl., Inc.
Dental · 139d
Cleared Jan 22, 1997
CALCIUM HYDROXIDE MEDICAMENT
K964191 · EJK
Sybron Dental Specialties, Inc.
Dental · 93d
Cleared Jan 22, 1997
TETRIC CERAM
K964285 · EBF
Ivoclar North America, Inc.
Dental · 86d
Cleared Jan 22, 1997
PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
K964525 · KLE
Dentsply Intl.
Dental · 71d
Cleared Jan 22, 1997
DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)
K964619 · EIA
Sds Dental, Inc.
Dental · 65d
Cleared Jan 17, 1997
SIRIUS 10, 10L, 40, 40L
K961275 · EFB
Micro-Mega Societe Anonyme
Dental · 289d
Cleared Jan 17, 1997
BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)
K964330 · DZE
BioHorizons Implant Systems, Inc.
Dental · 78d
Cleared Jan 17, 1997
PULPDENT SNOOP
K964430 · LFC
Pulpdent Corp.
Dental · 73d
Cleared Jan 17, 1997
AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)
K964772 · EJT
Ivoclar North America, Inc.
Dental · 51d
Cleared Jan 13, 1997
TAOS 28
K964940 · EJT
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
EL DORADO 40
K964941 · EJT
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
AURORA 52 (PM-01)
K964948 · EJT
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
AURORA 53
K964949 · EJT
Gateway Alloys, Inc.
Dental · 34d