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
5425–5448 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 16, 2004
CALIBRA CEMENT
K040906 · EMA
Dentsply Intl.
Dental · 70d
Cleared Jun 16, 2004
DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125
K041141 · EFB
Dentsply Intl.
Dental · 47d
Cleared Jun 16, 2004
PTM SYSTEM
K041335 · EIH
Dentsply International
Dental · 29d
Cleared Jun 16, 2004
XENO NM LIGHT CURED DENTAL ADHESIVE
K041343 · KLE
Dentsply International
Dental · 27d
Cleared Jun 16, 2004
MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS
K041402 · DZE
Implant Innovations, Inc.
Dental · 21d
Cleared Jun 15, 2004
STAY-PUT IMPREGNATED
K041023 · MVL
Coltene/Whaledent GmbH & Co. KG
Dental · 56d
Cleared Jun 14, 2004
HILUX LEDMAX 3
K040956 · EBZ
First Medical Infection Control...
Dental · 62d
Cleared Jun 09, 2004
RADENT PROPHY PASTE
K040661 · EJR
Pascal Co., Inc.
Dental · 89d
Cleared Jun 09, 2004
MIS DENTAL IMPLANT SYSTEM
K040807 · DZE
Mis - Implant Technologies , Ltd.
Dental · 72d
Cleared Jun 07, 2004
IRRIGATION TUBING SET 2.2M AND 3.8M
K041124 · EBW
W&H Dentalwerk Burmoos
Dental · 39d
Cleared Jun 03, 2004
BONAMATES SERIES
K040650 · JEY
Biotech One, Inc.
Dental · 84d
Cleared Jun 03, 2004
COSMEDENT CORE PASTE
K040994 · EBF
Cosmedent, Inc.
Dental · 48d
Cleared May 28, 2004
KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)
K040891 · DZE
KLS-Martin L.P.
Dental · 53d
Cleared May 28, 2004
PROCERA BRIDGE ZIRCONIA
K041283 · ELL
Nobel Biocare AB
Dental · 15d
Cleared May 27, 2004
PORTA REFLEX
K040672 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 73d
Cleared May 27, 2004
PROCERA ABUTMENT OCTAGON
K041275 · NHA
Nobel Biocare Uas, Inc.
Dental · 15d
Cleared May 26, 2004
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
K041236 · NHA
Nobel Biocare AB
Dental · 15d
Cleared May 25, 2004
METACRYL
K040881 · EBI
Great Lakes Orthodontics, Ltd.
Dental · 50d
Cleared May 24, 2004
RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT
K041295 · NHA
Institut Straumann AG
Dental · 10d
Cleared May 21, 2004
I-TEC PORTABLE DENTAL OPERATORY
K040153 · EBW
Indigenous Peoples Technology and...
Dental · 119d
Cleared May 21, 2004
INTEGRITY TEMPORARY CEMENT
K040895 · EMA
Dentsply Intl.
Dental · 45d
Cleared May 20, 2004
PORTA SOLDER 1090 W
K040524 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 80d
Cleared May 20, 2004
HERACERAM PRESS
K040859 · EIH
Heraeus Kulzer, Inc.
Dental · 48d
Cleared May 19, 2004
SR ADORO
K040951 · EBG
Ivoclar Vivadent, Inc.
Dental · 37d