MAX-I-PROBE IRRIGATION SYSTEM
FDA 510(k) clearance K913030 · decided 1991-09-30
Clearance details
- K-number
- K913030
- Device name
- MAX-I-PROBE IRRIGATION SYSTEM
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-07-09
- Decision date
- 1991-09-30
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- EFS
- Device class
- 1
- Regulation number
- 872.6510
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Franklin Park, IL, US
- Third-party review
- No
- Expedited review
- No
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| AGATHA-A-H2010 (K983374) | Midian Intl. | 1998-12-23 |
| DERMADAM (K964810) | Ultradent Products, Inc. | 1997-02-10 |
| BARRIER ALL FILM (K952234) | Cottrell, Ltd. | 1995-07-31 |
| ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (K943182) | Oral-B Laboratories | 1994-09-09 |
| PERIOFLEX TIP (K923711) | Novadent, Ltd. | 1994-05-16 |
| HYDRO FLOSS (K923937) | Hydro Floss, Inc. | 1994-02-25 |
| WATER PIK PLUS PLAQUE CONTROL SYSTEM (K931380) | Teledyne Water Pik | 1993-09-20 |
| SHOWERFLOSS (K923457) | Summit Marketing Group, Inc. | 1992-09-01 |
| SHOWERFLOSS ORAL IRRIGATION UNIT (K922307) | Showerfloss, Inc. | 1992-06-16 |
| INTERJET(TM) GINGIVAL CARE INSTRUMENT (K921999) | Bausch & Lomb, Inc. | 1992-06-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |