Clearfil Tri-S Bond Single Dose

FDA 510(k) K051796 · Kuraray Medical Kurashiki Plant

Substantially Equivalent

510(k) numberK051796

Submission

Device name
Clearfil Tri-S Bond Single Dose
Applicant
Kuraray Medical Kurashiki Plant
New York, NY, US
Received
July 5, 2005
Decision date
August 9, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KLE – Agent, Tooth Bonding, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3200
Specialty
Dental

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Questions and answers

When was Clearfil Tri-S Bond Single Dose cleared by the FDA?

Clearfil Tri-S Bond Single Dose (K051796) received a 510(k) decision of Substantially Equivalent on August 9, 2005, 35 days after the submission was received.

What is the product code of K051796?

The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.