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
5641–5664 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Oct 08, 2003
METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING
K032605 · KIF
Meta Biomed Co., Ltd.
Dental · 44d
Cleared Oct 07, 2003
DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT
K032195 · DYH
Dentaurum
Dental · 81d
Cleared Oct 07, 2003
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
K032603 · KIF
Meta Biomed Co., Ltd.
Dental · 43d
Cleared Oct 06, 2003
OPTIBAND LC
K032407 · DYH
Sybron Dental Specialties, Inc.
Dental · 63d
Cleared Oct 02, 2003
ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
K031439 · ELW
Harry J. Bosworth Co.
Dental · 149d
Cleared Oct 02, 2003
5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K032140 · DZE
Innova Life Sciences Corp.
Dental · 83d
Cleared Oct 02, 2003
MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS...
K032234 · EFB
Mk-Dent GmbH
Dental · 73d
Cleared Oct 02, 2003
XIVE TG ABUTMENTS
K032302 · DZE
Friadent GmbH
Dental · 69d
Cleared Oct 02, 2003
MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE
K032750 · DZE
Friandent GmbH
Dental · 27d
Cleared Oct 01, 2003
CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061,...
K022505 · EGS
NOUVAG AG
Dental · 429d
Cleared Oct 01, 2003
APPOLLO 3 ALLOY
K032320 · EJT
Dentsply International
Dental · 65d
Cleared Sep 30, 2003
TULIP COLORSWITCH
K032116 · ELW
Cavex Holland BV
Dental · 83d
Cleared Sep 30, 2003
ORION E ALLOY
K032316 · EJT
Dentsply Intl.
Dental · 64d
Cleared Sep 30, 2003
ORION GX ALLOY
K032317 · EJT
Dentsply Intl.
Dental · 64d
Cleared Sep 30, 2003
MINERVA 58 ALLOY
K032318 · EJT
Dentsply International
Dental · 64d
Cleared Sep 30, 2003
CERA R PLUS ALLOY
K032319 · EJT
Dentsply International
Dental · 64d
Cleared Sep 30, 2003
CERA F ALLOY
K032321 · EJT
Dentsply International
Dental · 64d
Cleared Sep 29, 2003
ENVISION
K032042 · DYH
Sybron Dental Specialties, Inc.
Dental · 90d
Cleared Sep 26, 2003
DW 296 #15 SOLDER
K032715 · EJT
Ivoclar Vivadent, Inc.
Dental · 24d
Cleared Sep 26, 2003
ULTRACROWN 75 ALLOY
K032851 · EJT
Dentsply International
Dental · 14d
Cleared Sep 26, 2003
MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM
K032892 · EBI
Dentsply Intl.
Dental · 9d
Cleared Sep 23, 2003
DIAMOND D HIGH IMPACT DENTURE ACRYLIC
K032773 · EBI
Mycone Dental Supply Co., Inc.
Dental · 15d
Cleared Sep 17, 2003
PRIMOSPLINT SYSTEM
K030832 · MQC
Cosmedent, Inc.
Dental · 184d
Cleared Sep 17, 2003
R&D DESIGNATION AP-052-5
K032267 · EJT
Jensen Industries, Inc.
Dental · 56d