SENSIMATIC 500SE
FDA 510(k) clearance K950239 · decided 1995-06-06
Clearance details
- K-number
- K950239
- Device name
- SENSIMATIC 500SE
- Applicant
- Parkell, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-20
- Decision date
- 1995-06-06
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- EKZ
- Device class
- 2
- Regulation number
- 872.4920
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Farmingdale, NY, US
- Third-party review
- No
- Expedited review
- No
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| BI-DENT (K982229) | Valley Forge Scientific Corp. | 1998-08-13 |
| ODONTOSURGE 2 (K981390) | Periogiene | 1998-06-11 |
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Recalls involving this device
No recalls on record reference this clearance.