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510(k) K250512

Device
Augmented Gingival Matrix
Applicant
Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
510(k) number
K250512
Product code
NPL
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-05
Date received
2025-02-21
Regulation
872.3930
Classification name
Barrier, Animal Source, Intraoral
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jade Guo
Address
Rm. 301,302, Bldg. 11, # 8 Jinfeng Rd., Suzhou New District Suzhou CN 215163 215163

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NPL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242817Jason membraneBotiss Biomaterials GmbH2025-12-12
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K250833SwissMembrane X; SwissMembrane X SocketGeistlich Pharma AG2025-04-15
K233203Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, Inc.2024-05-01
K231513Oral MatrixBeijing Biosis Healing Biolog Ical Technology Co., Ltd.2024-02-16
K231305Endoform Dental MembraneAroa Biosurgery , Ltd.2024-01-23
K230091THE CoverPurgo Biologics, Inc.2023-10-06
K223912InterCollagen® GuideSigmagraft, Inc.2023-08-17
K213904Kerecis OralKerecis2022-09-30
K212509OSSIX BreezeDatum Dental, Ltd.2022-07-18
K212463Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi PackGeistlich Pharma AG2022-04-05
K210280Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG2021-03-03
K201241Striate+™Orthocell, Ltd.2021-01-11
K192612Kerecis Gingiva GraftKerecis Limited2020-11-13