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
3793–3816 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Sep 23, 2010
ASCENT F-COAT MODEL: 006-00097
K100540 · LBH
CAO Group, Inc.
Dental · 210d
Cleared Sep 20, 2010
RELINE-IT MODEL RELINE-IT
K101771 · EBP
Majestic Drug Co., Inc.
Dental · 88d
Cleared Sep 17, 2010
ULTRASEAL ID
K101245 · EBC
Ultradent Products, Inc.
Dental · 136d
Cleared Sep 17, 2010
GC FUJI TEMP
K101420 · EMA
GC America, Inc.
Dental · 120d
Cleared Sep 15, 2010
CEROS TCP GRANULES
K101426 · LYC
Mathys, Ltd.
Dental · 117d
Cleared Sep 14, 2010
BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P
K101064 · ELM
Bredent GmbH & Co. KG
Dental · 151d
Cleared Sep 14, 2010
TAPERED SCREW-VENT T IMPLANT
K101977 · DZE
Zimmer Dental, Inc.
Dental · 62d
Cleared Sep 13, 2010
CLEARARCH
K101676 · DYW
Ormco Corp.
Dental · 90d
Cleared Sep 09, 2010
BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
K100985 · NHA
BioHorizons Implant Systems, Inc.
Dental · 153d
Cleared Sep 09, 2010
PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
K101551 · EFB
Delma Medical Instrument (Guangzhou)...
Dental · 97d
Cleared Sep 08, 2010
EMS MINIMASTER LED
K093723 · ELC
E.M.S Electro Medical Systems S.A
Dental · 279d
Cleared Sep 08, 2010
SNORE GUARD ADVANCE
K102118 · LRK
Ranir, LLC
Dental · 42d
Cleared Sep 07, 2010
FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY...
K101617 · ELW
Heraeus Kulzer, LLC
Dental · 90d
Cleared Sep 03, 2010
ROMIAPEX MODEL A-15
K101054 · LQY
Romidan, Ltd.
Dental · 141d
Cleared Aug 31, 2010
NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS
K101714 · NHA
Nobel Biocare AB
Dental · 74d
Cleared Aug 27, 2010
FS ALIGNER
K093821 · NXC
Allesee Orthodontic Appliances
Dental · 256d
Cleared Aug 26, 2010
STAR/VENT INTERNAL HEX SCREW IMPLANT
K082800 · DZE
Park Dental Research Corp.
Dental · 701d
Cleared Aug 26, 2010
ALL-ETCH, ALL- ETCH WITH BAC
K101485 · KLE
Bisco, Inc.
Dental · 90d
Cleared Aug 23, 2010
ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS
K101068 · NHA
Radiant Express, LLC
Dental · 129d
Cleared Aug 23, 2010
BEAUTIFIL FLOW PLUS
K101603 · EBF
Shofu Dental Corp.
Dental · 76d
Cleared Aug 23, 2010
LITE ART
K101621 · EBF
Shofu Dental Corp.
Dental · 75d
Cleared Aug 23, 2010
BK BLANK MODEL 20,40,65,90
K101875 · EIH
Bk Medent Co., Ltd.
Dental · 48d
Cleared Aug 20, 2010
NOBELPROCERA IPS E.MAX CROWN
K100512 · EIH
Nobel Biocare AB
Dental · 179d
Cleared Aug 20, 2010
DENTAL HANDPIECES, MODELS: KARAM STD/MINI
K101717 · EFB
Aerobine, Inc.
Dental · 63d