Search Results
Found 1 results
510(k) Data Aggregation
K Number
K231672Device Name
S1
Manufacturer
MedPark Co., Ltd.
Date Cleared
2023-10-13
(127 days)
Product Code
NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
MedPark Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
S1 is intended for the following uses:
· Augmentation or reconstructive treatment of the alveolar ridge;
- · Filling of infrabony periodontal defects
- · Filling of defects after root resection, apicocectomy, and cystectomy
- · Filling of extraction sockets to enhance preservation of the alveolar ridge
- · Elevation of the maxillary sinus floor
· Filling of periodontal defects in conjuncts intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
· Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Device Description
S1 is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.
S1 is serving as a matrix consisting of interconnected macro- and micropores. The material is porous and has inner surface area.
S1 is a mixture of Hydroxyapatite (HAp) and hydroxypropyl methylcellulose (HPMC). Hydroxyapatite (HAp) is made from bovine cancellous bone and is mineralized hydroxyapatite.
The bone particle size is 0.2 ~ 1.0mm for the powder type and 1.0 ~ 2.0 mm for the chip type. S1 is packaged in vials and it is supplied sterile by gamma irradiation and is for single use only.
Ask a Question
Page 1 of 1