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
8329–8352 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Mar 31, 1995
S & C VINYL POLYSILOXANE IMPRESSION MATERIAL
K951075 · ELW
S & C Polymer GmbH
Dental · 22d
Cleared Mar 31, 1995
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)
K951111 · DZE
Lifecore Biomedical, Inc.
Dental · 21d
Cleared Mar 29, 1995
STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL...
K944158 · DZE
Steri-Oss, Inc.
Dental · 215d
Cleared Mar 28, 1995
RESOLUT REGENERATIVE MATERIAL
K932866 · LYC
W.L. Gore & Associates, Inc.
Dental · 652d
Cleared Mar 28, 1995
INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO...
K950165 · LYC
Interpore Intl.
Dental · 70d
Cleared Mar 24, 1995
ITI TRANSVERSAL SCREWING SYSTEM
K943720 · DZE
The Straumann Co.
Dental · 235d
Cleared Mar 24, 1995
FUTURA ONE
K950187 · EJT
Degussa Corp.
Dental · 66d
Cleared Mar 23, 1995
T-GUARD
K945537 · LQX
Med ET AL Development
Dental · 129d
Cleared Mar 23, 1995
KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM
K950045 · JEY
Karl Leibinger GmbH U. Co. KG
Dental · 77d
Cleared Mar 23, 1995
THE STERN ROOT ANCHOR SYSTEM
K950213 · ELR
Sterngold/Implamed
Dental · 63d
Cleared Mar 23, 1995
HARMONY LINE PF
K950517 · EJT
Ivoclar North America, Inc.
Dental · 45d
Cleared Mar 23, 1995
PERMASEAL
K950859 · EBF
Ultradent Products, Inc.
Dental · 24d
Cleared Mar 23, 1995
PERMALUTE
K950860 · KLE
Ultradent Products, Inc.
Dental · 24d
Cleared Mar 23, 1995
NEOCAST C, V, S
K950951 · EJH
Neodontics, Inc.
Dental · 21d
Cleared Mar 23, 1995
DYRACT II RESTORATIVE
K950991 · EBF
Dentsply Intl.
Dental · 20d
Cleared Mar 21, 1995
DENTOOL
K923780 · EFB
Dentool, Inc.
Dental · 966d
Cleared Mar 17, 1995
VACSTAR
K942698 · EIA
Air Techniques, Inc.
Dental · 282d
Cleared Mar 16, 1995
VISTACAM
K943204 · EIA
Air Techniques, Inc.
Dental · 254d
Cleared Mar 16, 1995
AUROLITE 55
K950858 · EJT
Argen Precious Metals, Inc.
Dental · 17d
Cleared Mar 13, 1995
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION
K935544 · DZE
Implant Innovations International, Inc.
Dental · 486d
Cleared Mar 13, 1995
OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL
K944943 · DZE
Opti-Max
Dental · 157d
Cleared Mar 13, 1995
COMPA LAB-R
K950765 · EBF
Robert W. Bauer & Assoc., Inc.
Dental · 24d
Cleared Mar 13, 1995
ARGELITE 61 (PALLADIUM - SILVER DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)
K950772 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Mar 08, 1995
TRAV-LER KIT
K943942 · JEQ
John O. Butler Co.
Dental · 208d