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Panels › Dental › Product code NPM · Class 2

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)
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Top companies in NPM

Company510(k)sRecalls
Collagen Matrix, Inc.74
Geistlich Pharma AG90
Geistlich Pharma North America, Inc.06
Nibec Co., Ltd.30
Purgo Biologics, Inc.30
Medpark Co., Ltd.20
Sigmagraft, Inc.20
Wishbone SA20
Ace Surgical Supply Co., Inc.01
Chiyewon10
DateFirm and productCodeLinked 510(k)
Feb 2, 2022Ace 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
NPMK043034
Oct 19, 2020Geistlich 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
NPMK120601
Oct 19, 2020Geistlich 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
NPMK120601
Oct 19, 2020Geistlich 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
NPMK120601
Aug 2, 2019Geistlich 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
NPMK120601
Aug 2, 2019Geistlich 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
NPMK120601
Aug 2, 2019Geistlich 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
NPMK120601
Oct 30, 2018Collagen Matrix Inc
Porcine Anorganic Bone Mineral 4.0cc
Terminated
NPMK140714
Mar 11, 2016Collagen 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
NPMK043034
Nov 17, 2015Collagen 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
NPMK140714
Aug 25, 2015Collagen Matrix Inc
NuOSS Cancellous Intended for use in dental surgery.
Terminated
NPMK043034

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