(30 days)
CLEARFIL REPAIR is indicated for the following applications:
- Intraoral repairs of fractured porcelain or composite facing crowns/bridges.
- Intraoral repairs of fractured all ceramics restorations.
- Intraoral repairs of fractured porcelain and composite inlays/onlays.
CLEARFIL REPAIR is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials.
The provided text is a 510(k) summary for the medical device "CLEARFIL REPAIR" by KURARAY MEDICAL INC. The purpose of this submission is to transfer the medical device business and functions from Kuraray Co., Ltd. to its subsidiary, Kuraray Medical Inc., without intending other changes. Therefore, this document does not contain specific acceptance criteria or an efficacy study proving that the device meets such criteria.
Instead, the document states that the device is "essentially the same as CLEARFIL REPAIR manufactured by Kuraray Co., Ltd." and that its "technological characteristics, chemical ingredients and safety of this (K001914) device are completely the same as CLEARFIL REPAIR." This means the substantial equivalence determination for K012729 relies on the predicate device (K001914) having already met necessary safety and effectiveness criteria.
As a result, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies from this document, as it is a notification of a change in manufacturer rather than a submission of new performance data.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.