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
9529–9552 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Sep 16, 1991
TIN COATED DENTAL BURS
K911208 · EJL
Surgical Precision Instruments, Corp.
Dental · 181d
Cleared Sep 16, 1991
WHITER BITER CROWN
K912686 · ELZ
George M. Wilson, Dds
Dental · 90d
Cleared Sep 16, 1991
SATIN PROPHYLAXIS PASTE
K912945 · EJR
Dentsply Intl.
Dental · 73d
Cleared Sep 13, 1991
DENTAL NEEDLE PROTECTIVE SYSTEM
K910475 · DZM
Health Technology Systems, Inc.
Dental · 219d
Cleared Sep 13, 1991
X-L (DW228-14A) AND X-LX (DW228-24A)
K913070 · EJS
Ivoclar North America, Inc.
Dental · 64d
Cleared Sep 06, 1991
PULPDENT ENAMEL BONDING AGENT
K911282 · KLE
Pulpdent Corp.
Dental · 171d
Cleared Sep 06, 1991
ID-TAB
K913160 · EGZ
Nix Co. , Ltd.
Dental · 51d
Cleared Sep 06, 1991
SALIBAG
K913168 · EGZ
Nix Co. , Ltd.
Dental · 51d
Cleared Sep 06, 1991
ULTRACROWN(TM) PD DENTAL ALLOY
K913232 · EJS
Dentsply Intl.
Dental · 46d
Cleared Sep 05, 1991
HD-4 CROWN & BRIDGE ALLOY
K905034 · EJH
Ho Dental Co., Inc.
Dental · 302d
Cleared Aug 28, 1991
DENTAL CONNECTOR PRECISION ATTACHMENT
K912435 · EGG
Metalor Dental USA Corp.
Dental · 86d
Cleared Aug 23, 1991
CURAY SUPPORT
K912788 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 60d
Cleared Aug 21, 1991
INTRAORAL DENTAL WAX
K910676 · EGD
Pemaco, Inc.
Dental · 187d
Cleared Aug 21, 1991
OSTEOMED SBF SYSTEM (SBF)
K911936 · DZL
Osteomed Corp.
Dental · 112d
Cleared Aug 21, 1991
POLYESTER RESIN HAND MOLDED TRAY
K912820 · EBH
E&D Dental Products, Inc.
Dental · 57d
Cleared Aug 20, 1991
SCREW, BONE, MAXILLOFACIAL
K911165 · DZL
Tekno-Medical
Dental · 158d
Cleared Aug 20, 1991
DEGUBOND LITE
K912493 · EJS
Degussa AG
Dental · 77d
Cleared Aug 20, 1991
CLEARFIL LINER BOND SYSTEM
K912707 · KLE
Kuraray Co.
Dental · 62d
Cleared Aug 20, 1991
CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM
K912708 · EBF
Kuraray Co.
Dental · 62d
Cleared Aug 20, 1991
ENDO-CORE
K912720 · ELR
Metalor Dental USA Corp.
Dental · 63d
Cleared Aug 20, 1991
AUROFILM MP
K912721 · EJT
Metalor Dental USA Corp.
Dental · 63d
Cleared Aug 16, 1991
OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS
K905223 · DZE
Universal Implant Systems, Inc.
Dental · 269d
Cleared Aug 16, 1991
NOBELPHARMA CERAONE ABUTMENT SYSTEM
K910611 · DZE
Nobelpharma USA, Inc.
Dental · 185d
Cleared Aug 16, 1991
CERAPALL 6
K911669 · EJS
Metalor Dental USA Corp.
Dental · 127d