VANADIUM EXCAVATORS SIZES 0-6
FDA 510(k) clearance K834055 · decided 1984-02-21
Clearance details
- K-number
- K834055
- Device name
- VANADIUM EXCAVATORS SIZES 0-6
- Applicant
- Henry Schein, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-23
- Decision date
- 1984-02-21
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- EKC
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, 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 |
|---|---|---|
| 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS (K851722) | Artiberia | 1985-07-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Neos Vanadium Excavator Part Number 591/0 recall (Z-0151-2010) | Sybron Dental Specialties | 2009-11-09 |
| Neos Vanadium Excavator Part Number 591/1 recall (Z-0152-2010) | Sybron Dental Specialties | 2009-11-09 |
| Neos Vanadium Excavator Part Number 591/2 recall (Z-0153-2010) | Sybron Dental Specialties | 2009-11-09 |
| Neos Vanadium Excavator Part Number 591/4 recall (Z-0154-2010) | Sybron Dental Specialties | 2009-11-09 |
| Neos Vanadium Excavator Part Number 591/0-6 recall (Z-0155-2010) | Sybron Dental Specialties | 2009-11-09 |
| Neos Vanadium Excavator Part Number 591/0 SCHE recall (Z-0156-2010) | Sybron Dental Specialties | 2009-11-09 |
| Neos Vanadium Excavator Part Number 591/3 SCHE recall (Z-0157-2010) | Sybron Dental Specialties | 2009-11-09 |
| Neos Vanadium Excavator Part Number 591/5 SCHE recall (Z-0158-2010) | Sybron Dental Specialties | 2009-11-09 |