510(k) K120601 ยท NPM Bone Grafting Material, Animal Source
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, Washington DC, US |
| Decision | Substantially Equivalent, May 24, 2012 |
| Received | Feb 28, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120601
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 19, 2020 | Geistlich Pharma North America, Inc. Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115 Terminated |
NPM | None listed |
| Oct 19, 2020 | Geistlich Pharma North America, Inc. Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116 Terminated |
NPM | None listed |
| Oct 19, 2020 | Geistlich Pharma North America, Inc. Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126 Terminated |
NPM | None listed |
| Aug 2, 2019 | Geistlich Pharma North America, Inc. Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augmentation or reconstructive treatment of the alveolar r Terminated |
NPM | None listed |
| Aug 2, 2019 | Geistlich Pharma North America, Inc. Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - Product Usage: Augmentation or reconstructive treatment of the alveolar ri Terminated |
NPM | None listed |
| Aug 2, 2019 | Geistlich Pharma North America, Inc. Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Terminated |
NPM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.