RC-SwiftPrep
FDA 510(k) clearance K250279 · decided 2025-07-02
Clearance details
- K-number
- K250279
- Device name
- RC-SwiftPrep
- Applicant
- Belport Company, Inc., Gingi-Pak
- Decision
- Substantially Equivalent
- Date received
- 2025-01-31
- Decision date
- 2025-07-02
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- KJJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Camarillo, CA, US
- Third-party review
- No
- Expedited review
- No
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| ChlorCid, ChlorCid V, ChlorCid Surf (K173163) | Ultradent Products, Inc. | 2018-02-09 |
| Straumann PrefGel (K162311) | Institut Straumann AG | 2017-03-07 |
| PacEndo Chlorhexidine (K160577) | Pac-Dent International, Inc. | 2016-07-25 |
| PacEndo EDTA (K153528) | Pac-Dent International, Inc. | 2016-02-01 |
| PacEndo Sodium Hyprochlorite (K151852) | Pac-Dent International, Inc. | 2015-11-10 |
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Recalls involving this device
No recalls on record reference this clearance.