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
5449–5472 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared May 17, 2004
MULTICORE HB
K040795 · EBF
Ivoclar Vivadent, Inc.
Dental · 49d
Cleared May 14, 2004
LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
K030425 · JEY
Walter Lorenz Surgical, Inc.
Dental · 459d
Cleared May 14, 2004
BITESTRIP
K030869 · KZM
S.L.P. , Ltd.
Dental · 422d
Cleared May 14, 2004
CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL
K041028 · ELW
Crown Delta Corp.
Dental · 23d
Cleared May 13, 2004
COOL TEMP NATURAL
K041098 · EBG
Coltene AG
Dental · 16d
Cleared May 10, 2004
MODIFICATION TO ADPER PROMPT
K040857 · KLE
3M Espe AG Dental Products
Dental · 38d
Cleared May 05, 2004
LORENZ SELF-DRILLING IMF SCREW
K040983 · DZE
Walter Lorenz Surgical, Inc.
Dental · 20d
Cleared May 03, 2004
STRAUMANN GRANULES
K040646 · LYC
The Straumann Co.
Dental · 53d
Cleared Apr 30, 2004
APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
K033198 · ELC
Apoza Enterprise Co., Ltd.
Dental · 211d
Cleared Apr 30, 2004
RIVA LUTING
K040393 · EMA
Southern Dental Industries, Inc.
Dental · 73d
Cleared Apr 30, 2004
THE STRAUMANN ORTHO IMPLANT SYSTEM
K040469 · OAT
The Straumann Co.
Dental · 66d
Cleared Apr 28, 2004
ELEMENTS OBTURATION UNIT
K031664 · EKR
Sybron Endo/Analytic
Dental · 335d
Cleared Apr 28, 2004
NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236
K040573 · NHA
Nobel Biocare Uas, Inc.
Dental · 55d
Cleared Apr 28, 2004
MINI L.E.D. OEM MODULE
K040808 · EBZ
Satelec
Dental · 30d
Cleared Apr 27, 2004
OSTEOGEN SBRG
K033098 · LYC
Impladent , Ltd.
Dental · 211d
Cleared Apr 27, 2004
NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING
K033171 · DZE
Northern Implants, LLC
Dental · 210d
Cleared Apr 22, 2004
LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE,...
K033699 · DZE
Zest Anchors, Inc.
Dental · 149d
Cleared Apr 22, 2004
ULTRASONIC SCALER ELEGANCE MS-10 (25K)
K040396 · ELC
Rolence Enteprise, Inc.
Dental · 65d
Cleared Apr 22, 2004
GC INITIAL MC, AL AND LF
K040567 · EIH
GC America, Inc.
Dental · 49d
Cleared Apr 21, 2004
THE GNATHOMETER
K033092 · JEY
Ortho Gnathics, LLC
Dental · 205d
Cleared Apr 21, 2004
MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK
K033630 · DZE
Rhein 83 Srl
Dental · 156d
Cleared Apr 21, 2004
UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT
K040117 · EIA
Arrow Industries, LLC
Dental · 92d
Cleared Apr 20, 2004
HAWK INTRAORAL CAMERA AND ACCESSORIES
K040116 · EIA
Dxm Co., Ltd.
Dental · 91d
Cleared Apr 20, 2004
PULPDENT VLC RESIN CEMENT
K040236 · EMA
Pulpdent Corporation
Dental · 78d