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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,637 results
11497–11520 of 12,637
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Apr 25, 1984
CRYSTAR PORCELAIN MARGIN POWDER/LIQUID
K840873 · EIH
Shofu Dental Corp.
Dental · 58d
Cleared Apr 25, 1984
FIBERGLASS MOUTH MIRRORS
K841199 · EAX
Henry Schein, Inc.
Dental · 35d
Cleared Apr 24, 1984
FIBER HEMOFILTERS FH55-FH77 & 88
K840720 · KOJ
Gambro, Inc.
Dental · 67d
Cleared Apr 17, 1984
RESIL
K840548 · EBI
Parker Laboratories, Inc.
Dental · 69d
Cleared Apr 13, 1984
ESTIC MICROFILL
K840176 · EBF
Kulzer, Inc.
Dental · 87d
Cleared Apr 13, 1984
REX V
K840562 · EJH
Jeneric Ind.
Dental · 65d
Cleared Apr 13, 1984
PENTRA-FIL II
K840727 · EBF
Pentron Corp.
Dental · 52d
Cleared Apr 13, 1984
HYDROXYLAPATITE COATED ENDOSSEOUS DENT
K840750 · DZE
Calcitek, Inc.
Dental · 50d
Cleared Apr 13, 1984
INTERDENTAL WEDGES
K840984 · DZN
Healthco, Inc.
Dental · 38d
Cleared Apr 05, 1984
ALEXOTEK LINGUAL TUBES
K834446 · DZD
Alexotek Co.
Dental · 111d
Cleared Apr 05, 1984
DENTAL FLOSSING INSTRUMENT
K840093 · JES
Leverette Corp.
Dental · 86d
Cleared Apr 05, 1984
MAX-I-PROBE PERIODONTAL ENDODONTIC PROB
K840237 · EIC
Smith & Nephew, Mpl Division
Dental · 76d
Cleared Apr 05, 1984
PERIOGRAF DURAPATITE 40-60 MESH
K840260 · LYC
Sterling Drug, Inc.
Dental · 86d
Cleared Apr 05, 1984
CAT. 8 DENTAL DEVICES
K840312 · EMG
Imm Enterprises , Ltd.
Dental · 72d
Cleared Mar 30, 1984
HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST
K833304 · DZM
Smith & Nephew, Mpl Division
Dental · 189d
Cleared Mar 30, 1984
PRE-LOADED C-R TUBES FOR SYRINGE
K833725 · EBF
Centrix, Inc.
Dental · 158d
Cleared Mar 30, 1984
POCKETIP 4414
K834545 · EFS
Vipont Laboratories, Inc.
Dental · 94d
Cleared Mar 30, 1984
CHEMODENT CERAMIC METAL
K840014 · EJS
Chemodent Metal Co.
Dental · 86d
Cleared Mar 30, 1984
COLTENE BRILLIANT LUX
K840084 · EBF
Bauer, Cheng & Associates, Inc.
Dental · 80d
Cleared Mar 30, 1984
THERMOCRAFT PORCELAIN
K840642 · ELL
American Thermocraft Corp.
Dental · 44d
Cleared Mar 30, 1984
ORAL SAFE
K840805 · JER
Great Lakes Orthodontics, Ltd.
Dental · 35d
Cleared Mar 30, 1984
REMBRANDT SHADE MODIFICATION KIT
K841111 · EBF
Den-Mat Corp.
Dental · 15d
Cleared Mar 16, 1984
SATELEC SUPRASSON PIEZOMATIC P2
K832664 · ELC
Spelna, Inc.
Dental · 220d
Cleared Mar 16, 1984
SATELEC PROPHY UNIT PU 2000S
K832674 · ELC
Spelna, Inc.
Dental · 220d