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
6385–6408 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Apr 12, 2001
R-SI-LINE METAL-BITE
K010926 · ELW
R-Dental Dentalerzeugnisse GmbH
Dental · 16d
Cleared Apr 09, 2001
MIMIX BONE REPLACEMENT SYSTEM
K003494 · LYC
Biomet, Inc.
Dental · 147d
Cleared Apr 05, 2001
VERSALUX
K010133 · EBZ
Centrix, Inc.
Dental · 78d
Cleared Apr 05, 2001
TOTAL CURE
K010196 · EBF
Bisco, Inc.
Dental · 73d
Cleared Mar 28, 2001
NT SWIFT
K004031 · EKS
Dental Power, Inc.
Dental · 90d
Cleared Mar 27, 2001
WILLI GELLER CREAPEARL
K010160 · ELM
Jensen Industries, Inc.
Dental · 70d
Cleared Mar 27, 2001
CALEX CONDITIONER
K010176 · EJK
Stephen M Koral, Dmd
Dental · 68d
Cleared Mar 27, 2001
POLYCARBOXYLATE (PCA) CEMENT
K010240 · EMA
Rite-Dent Manufacturing Corp.
Dental · 61d
Cleared Mar 27, 2001
R & D DESIGNATION AP-035
K010414 · EJT
Jensen Industries, Inc.
Dental · 43d
Cleared Mar 27, 2001
R & D DESIGNATION AP-047
K010611 · EJT
Jensen Industries, Inc.
Dental · 26d
Cleared Mar 20, 2001
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K003271 · DZE
Institut Straumann AG
Dental · 153d
Cleared Mar 16, 2001
SPECULITE/ORALLITE
K003995 · EAZ
Trylon Corp.
Dental · 80d
Cleared Mar 15, 2001
ULTRAPAK NEHA
K010070 · MVL
Ultradent Products, Inc.
Dental · 66d
Cleared Mar 15, 2001
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
K010351 · JEY
Inion , Ltd.
Dental · 37d
Cleared Mar 14, 2001
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
K010352 · JEY
Inion , Ltd.
Dental · 36d
Cleared Mar 14, 2001
BIOSORBFX AND BIOSORBPDX MESH
K010687 · JEY
Bionx Implants, Inc.
Dental · 6d
Cleared Mar 08, 2001
HERACERAM 75
K010416 · EJT
Jelenko Co.
Dental · 24d
Cleared Mar 06, 2001
D.SIGN 30
K010381 · EJH
Ivoclar North America, Inc.
Dental · 26d
Cleared Mar 01, 2001
TAKE 1
K003808 · ELW
Sybron Dental Specialties, Inc.
Dental · 83d
Cleared Mar 01, 2001
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K010320 · LYC
Depuyacromed
Dental · 27d
Cleared Feb 28, 2001
TETRIC CERAM HB
K010250 · EBF
Ivoclar North America, Inc.
Dental · 33d
Cleared Feb 27, 2001
SMF RESORBABLE MESHES AND SHEETS
K003786 · JEY
Synthes (Usa)
Dental · 81d
Cleared Feb 27, 2001
PALFIQUE ESTELITE LV CLEAR
K010267 · EBF
Tokuyama America, Inc.
Dental · 29d
Cleared Feb 27, 2001
DUO-DENT DENTAL IMPLANT
K010386 · DZE
Duo-Dent Dental Implant Systems, LLC
Dental · 19d