GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O
FDA 510(k) clearance K120601 · decided 2012-05-24
Clearance details
- K-number
- K120601
- Device name
- GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O
- Applicant
- Geistlich Pharma AG
- Decision
- Substantially Equivalent
- Date received
- 2012-02-28
- Decision date
- 2012-05-24
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- NPM
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For recall (Z-2145-2019) | Geistlich Pharma North America, Inc. | 2019-08-02 |
| Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For s recall (Z-2146-2019) | Geistlich Pharma North America, Inc. | 2019-08-02 |
| Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For singl recall (Z-2147-2019) | Geistlich Pharma North America, Inc. | 2019-08-02 |