SIMILE FLOW
FDA 510(k) clearance K052106 · decided 2005-10-31
Clearance details
- K-number
- K052106
- Device name
- SIMILE FLOW
- Applicant
- Pentron Clinical Technologies
- Decision
- Substantially Equivalent
- Date received
- 2005-08-03
- Decision date
- 2005-10-31
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- EBF
- Device class
- 2
- Regulation number
- 872.3690
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Wallingford, CT, US
- Third-party review
- No
- Expedited review
- No
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| Dual Core (K260805) | Vericom Co., Ltd. | 2026-05-11 |
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| Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (K260783) | Kulzer, LLC | 2026-03-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Artiste Flowable Value Pack Part Number N28VA, Syringe Lot Number 165741 The intended use recall (Z-1000-2012) | Sybron Dental Specialties | 2012-02-13 |
| Artiste Flowable Part Number N28A, Syringe Lot Number 165741 The intended use of the devic recall (Z-1005-2012) | Sybron Dental Specialties | 2012-02-13 |
| Flow Tec Part Number 3784-514, Syringe Lot Number 165741 The intended use of the device is recall (Z-1006-2012) | Sybron Dental Specialties | 2012-02-13 |
| Flow Tec Part Number 3786-754, Syringe Lot Number 165741 The intended use of the device is recall (Z-1007-2012) | Sybron Dental Specialties | 2012-02-13 |
| Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A N28V recall (Z-0989-2012) | Sybron Dental Specialties | 2012-02-11 |
| Flow Tec Nano-Hybrid Flowable Affected Product Syringe Part No. Value Pack Part. No. Shade recall (Z-0990-2012) | Sybron Dental Specialties | 2012-02-11 |