P2 POLYETHER
FDA 510(k) clearance K030318 · decided 2003-04-03
Clearance details
- K-number
- K030318
- Device name
- P2 POLYETHER
- Applicant
- Heraeus Kulzer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-01-30
- Decision date
- 2003-04-03
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- South Bend, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585. recall (Z-0624-05) | Heraeus Kulzer Inc. | 2005-03-15 |
| Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy + Light; catalog number 66009583. recall (Z-0625-05) | Heraeus Kulzer Inc. | 2005-03-15 |
| Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584. recall (Z-0626-05) | Heraeus Kulzer Inc. | 2005-03-15 |
| Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582. recall (Z-0627-05) | Heraeus Kulzer Inc. | 2005-03-15 |