MTA Repair HP

FDA 510(k) K151047 · Angelus Industria DE Productos Odontologicos

Substantially Equivalent

510(k) numberK151047

Submission

Device name
MTA Repair HP
Applicant
Angelus Industria DE Productos Odontologicos
Londrina, Pr, BR
Received
April 20, 2015
Decision date
August 31, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KIF – Resin, Root Canal Filling
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3820
Specialty
Dental

Other 510(k)s with product code KIF

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K262050Vioseal XKIF · Traditional Spident Co., Ltd.09/11/2026SE
K253909NeoPEX™ Pre-Mixed Obturation PasteKIF · Traditional NuSmile, Ltd.09/04/2026SE
K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)KIF · Traditional Guilin Kevin Peter Technology Co., Ltd.08/25/2026SE
K261415Injectable Root Canal Sealer (KP-Root SP)KIF · Traditional Guilin Kevin Peter Technology Co., Ltd.06/29/2026SE
K253167Any-PasteKIF · Traditional Mediclus Co., Ltd.01/12/2026SE
K252890ZenSeal ProKIF · Traditional Kerr Corporation01/07/2026SE
K251465Root canal repair materials (nRoot BP)KIF · Traditional Enpuno Biotechnology Co., Ltd.09/25/2025SE
K252285Well-Root PTKIF · Traditional Vericom Co., Ltd.09/19/2025SE
K251884One-Fil Putty InjectableKIF · Special Mediclus Co., Ltd.08/22/2025SE
K251390MTA vptKIF · Traditional Voco GmbH07/03/2025SE

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K112046Mta AngelusKIF · Traditional 01/06/2012SE
K082180Perma Fiber,Model 441; Perma Mesh, Model 440EBI · Traditional 12/17/2008SE

Questions and answers

When was MTA Repair HP cleared by the FDA?

MTA Repair HP (K151047) received a 510(k) decision of Substantially Equivalent on August 31, 2016, 499 days after the submission was received.

What is the product code of K151047?

The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.