Bone Grafting Material, Animal Source
Regulation 872.3930
3510(k)s in 12 months (42 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in NPM
| Company | 510(k)s | Recalls |
|---|---|---|
| Collagen Matrix, Inc. | 7 | 4 |
| Geistlich Pharma AG | 9 | 0 |
| Geistlich Pharma North America, Inc. | 0 | 6 |
| Nibec Co., Ltd. | 3 | 0 |
| Purgo Biologics, Inc. | 3 | 0 |
| Medpark Co., Ltd. | 2 | 0 |
| Sigmagraft, Inc. | 2 | 0 |
| Wishbone SA | 2 | 0 |
| Ace Surgical Supply Co., Inc. | 0 | 1 |
| Chiyewon | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2022 | Ace Surgical Supply Co., Inc. NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects.
Catalog Number: 5099250 Open, Classified |
NPM | K043034 |
| 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 | K120601 |
| 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 | K120601 |
| 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 | K120601 |
| 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 | K120601 |
| 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 | K120601 |
| 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 | K120601 |
| Oct 30, 2018 | Collagen Matrix Inc Porcine Anorganic Bone Mineral 4.0cc Terminated |
NPM | K140714 |
| Mar 11, 2016 | Collagen Matrix Inc NuOss XC Sinus
Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height)
Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height)
Manufacturer:- Collagen Matrix,
Distributor:- ACE Terminated |
NPM | K043034 |
| Nov 17, 2015 | Collagen Matrix Inc ZCORE Porcine Xenograft Particulate in Syringe
Product Intended for use in dental surgery such as:
-Augmentation or reconstructive treatment of alveolar ridge
-filling of defects after root resection Terminated |
NPM | K140714 |
| Aug 25, 2015 | Collagen Matrix Inc NuOSS Cancellous
Intended for use in dental surgery. Terminated |
NPM | K043034 |
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