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510(k) Data Aggregation
K Number
K181854Device Name
OssBuilder System
Manufacturer
Osstem Implant Co., Ltd..
Date Cleared
2019-05-07
(300 days)
Product Code
DZL, NHA
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
Osstem Implant Co., Ltd..
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OssBuilder System is used for space maintenance and stabilization of bone grafting material in an alveolar bone defect site.
Device Description
OssBuilder System is consisted of metal devices, OssBuilder, Healing Cap, Cover Cap, OB Anchor, and Tenting Screw, and is intended for use to stabilize and support of bone graft in dento-alveolar bony defect sites.
Tenting Screw, a product in the OssBuilder System product group, is a temporary dental implant that can be implanted in the bone defect site of the alveolar bone to fix the guided tissue regeneration material.
Healing Cap is used by connecting with the Tenting Screw to bind OssBuilder during osseointegration.
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K Number
K172354Device Name
OssBuilder System
Manufacturer
Osstem Implant Co., Ltd..
Date Cleared
2018-03-26
(235 days)
Product Code
JEY, NHA
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
Osstem Implant Co., Ltd..
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
Device Description
OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites. It is consisted of OssBuilder, Healing Cap, Cover Cap, and OB Anchor. The OssBuilder System is not indicated for permanent implantation.
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K Number
K170736Device Name
HySil Impression Materials
Manufacturer
Osstem Implant Co., Ltd..
Date Cleared
2017-06-07
(89 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
Osstem Implant Co., Ltd..
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HySil Putty is to be used as preliminary materials for:
- Two-step Putty-wash impression technique .
- · One-step Putty-wash impression technique
HySil Heavy is to be used as heavy-bodied materials for:
- . One-step impression technique (simultaneous technique)
using single or dual viscosities
- · Two-step impression technique using dual viscosities
- · Functional impressions
HySil Mono is to be used as a medium-bodied tray or syringeable impression material for:
- Taking impressions over fixed/removable restorations and implants (i.e., transferring .
- impression posts and bridge components)
- · Functional impressions
- · Fabricating crown and bridgework or inlays
- · Fabricating full or partial dentures
- . Reline impressions
- · Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
- · Transferring root posts when fabricating posts and cores indirectly
HySil Light is to be used as syringeable impression materials for:
- Two-step putty-wash impression technique .
- · One-step putty-wash impression technique
- · Two-step impression technique using dual viscosities
- · Reline impressions
- · Fabricating full or partial dentures
HySil Extra Light is to be used as syringeable impression materials for:
- Two-step putty-wash impression technique .
- · One-step putty-wash impression technique
- · Two-step impression technique using dual viscosities
- · Reline impressions
- Fabricating full or partial dentures
HySil Bite is used for impression as below.
- Taking occlusal surfaces
- Confirming occlusal surfaces
- · Recording after putting the articulator
Device Description
HySil Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The HySil impression materials family consists of six different viscosities (putty, heavy, mono, light. Extra-light and Bite) available in an assortment of delivery systems: standard 1:1 50 ml automix cartridges, and traditional 1:1 putty jars.
Putty, Heavy, Mono, Light and Extra-light of this proposed devices are classified into Type 0, Type 1, Type 2, and Type 3 according to ISO 4823, and Bite is classified as Dentistry - Jaw relation recording material according to DIN 13903 HySil Bite is an addition-curing silicone bite registration materials in a 50ml cartridge type to measure accurate bite. HySil Bite is suitable for bite registration as it has a short setting time, high final hardness after curing for user convenience, and less elastic deformation when eliminated.
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