Fiberfill Agp
FDA 510(k) K023818 · Pentron Clinical Technologies
510(k) numberK023818
Submission
- Device name
- Fiberfill Agp
- Applicant
- Pentron Clinical Technologies
Wallingford, CT, US - Received
- November 15, 2002
- Decision date
- April 3, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| K262050 | Vioseal XKIF · Traditional | Spident Co., Ltd. | 09/11/2026SE |
| K253909 | NeoPEX Pre-Mixed Obturation PasteKIF · Traditional | NuSmile, Ltd. | 09/04/2026SE |
| K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal)KIF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 08/25/2026SE |
| K261415 | Injectable Root Canal Sealer (KP-Root SP)KIF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 06/29/2026SE |
| K253167 | Any-PasteKIF · Traditional | Mediclus Co., Ltd. | 01/12/2026SE |
| K252890 | ZenSeal ProKIF · Traditional | Kerr Corporation | 01/07/2026SE |
| K251465 | Root canal repair materials (nRoot BP)KIF · Traditional | Enpuno Biotechnology Co., Ltd. | 09/25/2025SE |
| K252285 | Well-Root PTKIF · Traditional | Vericom Co., Ltd. | 09/19/2025SE |
| K251884 | One-Fil Putty InjectableKIF · Special | Mediclus Co., Ltd. | 08/22/2025SE |
| K251390 | MTA vptKIF · Traditional | Voco GmbH | 07/03/2025SE |
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| K091512 | Build-It Light CureEBF · Traditional | 10/30/2009SE |
| K081887 | Lute-It II Veneer Cement, Model NO6EMA · Traditional | 08/29/2008SE |
| K072830 | RM Bond, Model J032DYH · Traditional | 12/04/2007SE |
| K072480 | Generation 8 Se AdhesiveKLE · Traditional | 11/21/2007SE |
| K072545 | Artiste Se Flowable Composite, Model N280EBF · Traditional | 10/26/2007SE |
| K071500 | Nano-Bond II Adhesive SystemKLE · Traditional | 08/10/2007SE |
| K060889 | Se Epiphany Root Canal Sealant, Model N59SEKIF · Traditional | 10/27/2006SE |
| K060698 | Cement-It All Purpose, Model N97EMA · Traditional | 05/10/2006SE |
| K052106 | Simile FlowEBF · Traditional | 10/31/2005SE |
| K052349 | Avante LED Curing Unit, Model N44EBZ · Traditional | 10/21/2005SE |
Questions and answers
When was Fiberfill Agp cleared by the FDA?
Fiberfill Agp (K023818) received a 510(k) decision of Substantially Equivalent on April 3, 2003, 139 days after the submission was received.
What is the product code of K023818?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.