Root Canal XR
FDA 510(k) K083062 · S & C Polymer GmbH
510(k) numberK083062
Submission
- Device name
- Root Canal XR
- Applicant
- S & C Polymer GmbH
Elmshorn, DE - Received
- October 14, 2008
- Decision date
- March 12, 2009
- 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 |
More from Voco GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K091735 | DC Provi Cem Esthetic, Esthetic Multi F, ImplantEMA · Traditional | 09/25/2009SE |
| K083766 | Phoglass CemEMA · Traditional | 03/02/2009SE |
| K082115 | Phoglass Fill, Core, Cem, Seal, Prime and Phoglass ProtectEMA · Traditional | 01/15/2009SE |
| K081702 | Carboxylate Cem, Phosphate CemEMA · Traditional | 09/05/2008SE |
| K042614 | S&C-Self Etch Pr-BondKLE · Traditional | 11/22/2004SE |
| K031420 | S & C -Bracket AdhesivesDYH · Traditional | 08/20/2003SE |
| K012767 | S & C Hydro Vinyl Polysiloxane Impression MaterialELW · Traditional | 11/01/2001SE |
| K011277 | Hard RelinerEBI · Traditional | 06/26/2001SE |
| K011431 | Resin CemEMA · Traditional | 06/11/2001SE |
| K011064 | Classic CemEMA · Traditional | 05/17/2001SE |
Questions and answers
When was Root Canal XR cleared by the FDA?
Root Canal XR (K083062) received a 510(k) decision of Substantially Equivalent on March 12, 2009, 149 days after the submission was received.
What is the product code of K083062?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.