FDA.reportPublic FDA data

510(k) K221808

Device
InterOss Collagen
Applicant
Sigmagraft, Inc.
510(k) number
K221808
Product code
NPM
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-18
Date received
2022-06-22
Regulation
872.3930
Classification name
Bone Grafting Material, Animal Source
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Elcin Chang
Address
575 Sally Pl. Fullerton CA US 92831 92831

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NPM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AG2025-07-11
K251613SwissGraft XGeistlich Pharma AG2025-06-26
K242510Geistlich Bio-Flow®Geistlich Pharma AG2025-03-07
K240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLC2024-08-16
K230305THE Graft CollagenPurgo Biologics, Inc.2024-07-24
K240661Geistlich Bio-Oss®Geistlich Pharma AG2024-07-12
K231672S1Medpark Co., Ltd.2023-10-13
K211551Wishbone HAWishbone SA2021-08-20
K202183Porcine Mineral Collagen CompositeCollagen Matrix, Inc.2021-04-02
K201859Porcine Mineral Collagen Composite MoldableCollagen Matrix, Inc.2020-09-11
K193212DSM Biomedical Dental Bone Graft PlusDsm Biomedical2020-09-10
K191737The Graft Bone SubstitutePurgo Biologics, Inc.2020-02-14
K173594Straumann ceraboneInstitut Straumann AG2018-10-19
K173188The Graft Natural Bone SubstitutePurgo Biologics, Inc.2018-07-20
K171008Anorganic Bone Mineral with Collagen in Delivery ApplicatorCollagen Matrix, Inc.2017-10-30