CHX=CHX PLUS
FDA 510(k) clearance K112250 · decided 2011-10-28
Clearance details
- K-number
- K112250
- Device name
- CHX=CHX PLUS
- Applicant
- Inter-Med, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-08-04
- Decision date
- 2011-10-28
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- KJJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Racine, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RC-SwiftPrep (K250279) | Belport Company, Inc., Gingi-Pak | 2025-07-02 |
| Sealer Solvent (K241354) | Inter-Med, Inc. | 2024-08-27 |
| EPIEN Dental Cleanser (K201785) | Epien Medical, Inc. | 2021-09-09 |
| Triton (K211813) | Inter-Med / Vista Dental | 2021-08-18 |
| V-Mix (K193357) | Inter-Med/Vista Dental Products | 2020-10-23 |
| Vista Rinse, Vista Rinse Plus (K193409) | Inter-Med/Vista Dental Products | 2020-09-09 |
| RC-Prime Root Canal Preparation Cream (K200330) | Pac-Dent, Inc. | 2020-07-06 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.