Medical Device Manufacturer · US , New York , NY

Kuraray Co. - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 1985
25
Total
25
Cleared
0
Denied

Kuraray Co. is a Japanese manufacturer of chemicals, fibers, and advanced materials. The company maintains a US presence through its New York office.

Kuraray received 25 FDA 510(k) clearances from 25 total submissions, with all submissions focused on Dental devices. The company's regulatory activity spans from 1985 to 1999, establishing a historical record in dental bonding and restorative materials.

The cleared devices reflect Kuraray's specialization in dental adhesive systems and bonding technologies. Products include resin cements, surface activators, and liner bond systems used in restorative and cosmetic dentistry applications.

Explore the complete list of device names, product codes, and individual clearance dates in the database records below.

FDA 510(k) Regulatory Record - Kuraray Co.

25 devices
1-25 of 25
Cleared Feb 04, 1999
CLEARFIL SE BOND
K990040 · KLE
Dental · 29d
Cleared Jul 11, 1995
CARIES DETECTOR
K951813 · LFC
Dental · 84d
Cleared Feb 24, 1994
PANAVIA 21
K933030 · EMA
Dental · 247d
Cleared Jan 28, 1993
PHOTO CLEARFIL OPAQUER
K925383 · EBF
Dental · 97d
Cleared Jan 11, 1993
CLEARFIL PORCELAIN BOND ACTIVATOR
K925404 · KLE
Dental · 80d
Cleared Aug 20, 1991
CLEARFIL LINER BOND SYSTEM
K912707 · KLE
Dental · 62d
Cleared Aug 20, 1991
CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM
K912708 · EBF
Dental · 62d
Cleared Apr 03, 1991
TEETHMATE-F
K910424 · EMA
Dental · 63d
Cleared Apr 13, 1990
CLEARFIL VENEER BOND KIT
K900690 · EBF
Dental · 59d
Cleared Mar 14, 1990
TEETHMATE-A
K897027 · EBC
Dental · 86d
Cleared Mar 31, 1989
CLEARFIL CR INLAY
K890123 · EBF
Dental · 79d
Cleared Jun 13, 1988
CLEARFIL PHOTO CORE
K882006 · EBF
Dental · 31d
Cleared Mar 02, 1988
CLEARFIL PHOTO POSTERIOR
K872588 · EBF
Dental · 245d
Cleared Nov 20, 1987
CLEARFIL PHOTO BOND
K872959 · KLE
Dental · 114d
Cleared Nov 12, 1987
CLEARFIL PORCELAIN REPAIR SYSTEM
K873886 · EBF
Dental · 50d
Cleared Aug 11, 1987
CLEARFIL POSTERIOR NEW BOND
K872960 · EBF
Dental · 13d
Cleared Jul 17, 1987
CLEARFIL FII NEW BOND
K871634 · EBF
Dental · 81d
Cleared Jul 17, 1987
CLEARFIL CORE NEW BOND
K871637 · EBF
Dental · 81d
Cleared Jul 16, 1987
CLEARFIL POSTERIOR 3
K871635 · EBF
Dental · 80d
Cleared Jul 02, 1987
CLEARFIL PORCELAIN BOND
K871636 · KLE
Dental · 66d
Cleared Sep 05, 1986
PHOTO CLEARFIL BRIGHT
K862942 · EBF
Dental · 31d
Cleared Jul 29, 1986
PANAVIA TC, AND PANAVIA OPAQUE
K862232 · EBF
Dental · 48d
Cleared Apr 17, 1986
PHOTO CLEARFIL OPAQUER
K860708 · EBF
Dental · 50d
Cleared Mar 13, 1986
PANAVIA EX, A DENTAL ADHESIVE
K855211 · EMA
Dental · 73d
Cleared Apr 08, 1985
PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST
K850824 · EBF
Dental · 39d
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