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
10465–10488 of 12,637
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Apr 07, 1989
M-56 GOLD BASE DENTAL ALLOY
K891526 · EJT
Macdonald Metals and Ceramics
Dental · 21d
Cleared Apr 07, 1989
ORTHODONTIC ARCH AND SURGICAL HOOKS
K891592 · EJF
American Orthodontics
Dental · 18d
Cleared Mar 31, 1989
MANDIBLE MANIPULATOR
K884308 · EKJ
Leonard Medical, Inc.
Dental · 169d
Cleared Mar 31, 1989
CLEARFIL CR INLAY
K890123 · EBF
Kuraray Co.
Dental · 79d
Cleared Mar 31, 1989
PREFORMED TEMPLATE FOR TOOTH POSITIONER
K891328 · KMY
American Orthodontics
Dental · 21d
Cleared Mar 31, 1989
ORTHODONTIC PLASTIC BRACKET
K891372 · DYW
American Orthodontics
Dental · 22d
Cleared Mar 29, 1989
PHOSPHORIC-ACID ETCHING GEL
K890140 · EBF
Centrix, Inc.
Dental · 75d
Cleared Mar 29, 1989
BRACE (ORAFIX SPECIAL)
K890290 · ECB
Norcliff Thayer, Inc.
Dental · 69d
Cleared Mar 29, 1989
FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS
K890494 · EBC
Macrochem Corp.
Dental · 57d
Cleared Mar 29, 1989
RUBBER DAM
K890667 · EIE
Cost Rite Health Products, Inc.
Dental · 48d
Cleared Mar 17, 1989
DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.
K883842 · ELW
Dentsply Intl.
Dental · 186d
Cleared Mar 17, 1989
BRACKET TABLE ARM COVER
K884219 · EIA
Steri-Shield Products, Inc.
Dental · 162d
Cleared Mar 17, 1989
AIR WATER SYRINGE TIP SHIELD
K884220 · EFS
Steri-Shield Products, Inc.
Dental · 162d
Cleared Mar 17, 1989
ULTRASONIC SCALER COVER
K884221 · ELC
Steri-Shield Products, Inc.
Dental · 162d
Cleared Mar 17, 1989
CURING LIGHT COVER
K884222 · EBZ
Steri-Shield Products, Inc.
Dental · 162d
Cleared Mar 17, 1989
DENTAL LAMP HANDLE COVER
K884223 · EAZ
Steri-Shield Products, Inc.
Dental · 162d
Cleared Mar 17, 1989
MASSAGING PICK FOR ORAL HYGIENE
K885189 · JET
Dentek Corp.
Dental · 91d
Cleared Mar 17, 1989
THE CLARK LIP SHIELD
K890581 · EJF
American Orthodontics
Dental · 39d
Cleared Mar 17, 1989
RX APF (CASTING ALLOY)
K890811 · EJS
Jeneric/Pentron, Inc.
Dental · 29d
Cleared Mar 17, 1989
HEADS TRUE BRUSH
K890812 · EFW
Mcs Trading Co.
Dental · 29d
Cleared Mar 16, 1989
SANI-SLEEVE DRAPE FOR DENTAL USE
K885299 · EIA
Nieusma R & D, Inc.
Dental · 79d
Cleared Mar 16, 1989
PLAKOF
K890910 · JET
Ximex, Ltd.
Dental · 21d
Cleared Mar 13, 1989
ROS-TR SYSTEM
K884140 · DZE
Ross Systems C/O...
Dental · 164d
Cleared Mar 13, 1989
20/20 ORTHODONTIC CERAMIC BRACKET
K890145 · EJF
American Orthodontics
Dental · 59d