RC-Prime Root Canal Preparation Cream
FDA 510(k) K200330 · Pac-Dent, Inc.
510(k) numberK200330
Submission
- Device name
- RC-Prime Root Canal Preparation Cream
- Applicant
- Pac-Dent, Inc.
Brea, CA, US - Received
- February 10, 2020
- Decision date
- July 6, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KJJ – Cleanser, Root Canal
- Device class
- Unclassified
Other 510(k)s with product code KJJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250279 | RC-SwiftPrepKJJ · Traditional | Belport Company, Inc., Gingi-Pak | 07/02/2025SE |
| K241354 | Sealer SolventKJJ · Traditional | Inter-Med, Inc. | 08/27/2024SE |
| K201785 | EPIEN Dental CleanserKJJ · Traditional | Epien Medical, Inc. | 09/09/2021SE |
| K211813 | TritonKJJ · Special | Inter-Med / Vista Dental | 08/18/2021SE |
| K193357 | V-MixKJJ · Traditional | Inter-Med/Vista Dental Products | 10/23/2020SE |
| K193409 | Vista Rinse, Vista Rinse PlusKJJ · Traditional | Inter-Med/Vista Dental Products | 09/09/2020SE |
| K173163 | ChlorCid, ChlorCid V, ChlorCid SurfKJJ · Traditional | Ultradent Products, Inc. | 02/09/2018SE |
| K162311 | Straumann PrefGelKJJ · Traditional | Institut Straumann AG | 03/07/2017SE |
| K160577 | PacEndo ChlorhexidineKJJ · Traditional | Pac-Dent International, Inc. | 07/25/2016SE |
| K153528 | PacEndo EDTAKJJ · Traditional | Pac-Dent International, Inc. | 02/01/2016SE |
More from Pac-Dent International, Inc.
| 510(k) | Device | Decision |
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| K202674 | Medidenta High Speed HandpiecesEFB · Traditional | 12/12/2022SE |
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| K202831 | The iMask Child's Face MaskOXZ · Traditional | 08/26/2021SE |
| K210189 | Pac-Dent Denture Base ResinEBI · Traditional | 07/28/2021SE |
| K210412 | Pac-Dent Ceramic Nanohybrid ResinEBF · Traditional | 07/26/2021SE |
| K210186 | PacBond OneKLE · Traditional | 07/16/2021SE |
| K201182 | iMask Disposable Surgical Face MaskFXX · Traditional | 02/19/2021SE |
Questions and answers
When was RC-Prime Root Canal Preparation Cream cleared by the FDA?
RC-Prime Root Canal Preparation Cream (K200330) received a 510(k) decision of Substantially Equivalent on July 6, 2020, 147 days after the submission was received.
What is the product code of K200330?
The FDA product code is KJJ – Cleanser, Root Canal, a Unclassified device.