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Found 17 results
510(k) Data Aggregation
K Number
K232528Device Name
Protective Cap
Manufacturer
Neobiotech Co., Ltd.
Date Cleared
2024-04-30
(253 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Neobiotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Protective Cap is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdenture, and can be used for a minimum of 1 day to maximum of 10 days.
Device Description
The Protective Cap is a dental implant superstructure made of PC(Polycarbonate) according to ASTM F997. It is used temporarily, such as less than 10 days before the final restoration is connected. The Protective Cap is supplied nonsterile and intended for single use. It is to be sterilized by end users before use.
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K Number
K232049Device Name
IS-III active Short Implant
Manufacturer
Neobiotech Co., Ltd.
Date Cleared
2024-03-28
(262 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Neobiotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IS-III active Short Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. The IS-III active Short Implants are indicated for the molar region with delayed loading.
Device Description
IS-III active Short Implant is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The Fixture's diameters are 5.0/5.5/6.0mm and the length is 6.6 mm. Tolerance of dimension shall be within ± 1% range.
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K Number
K210903Device Name
IS Multi Unit Abutment System
Manufacturer
Neobiotech Co., Ltd.
Date Cleared
2021-07-23
(119 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Neobiotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IS Multi Unit Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as bridges.
Device Description
IS Multi Unit Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant with internal hex connections (multiple tooth). IS Multi Unit Abutment System is made of Titanium ELI according to ASTM F136.
IS Multi Unit Abutment System is composed of IS Multi Unit Abutment, IS Multi Unit Angled Abutment, Multi Unit Abutment Cylinder, Multi Unit Healing Cap, Multi Unit Temporary Cylinder, IS Multi Unit Angled Abutment Screw and Cylinder Screw.
All Multi-Unit Abutments (Straight/Angled) are intended only for multi-unit loaded restoration.
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K Number
K190849Device Name
IS-III active System_S-narrow Type
Manufacturer
Neobiotech Co., Ltd.
Date Cleared
2019-08-14
(135 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Neobiotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IS-III active System S-narrow Type is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
The IS-III active System S-narrow Type is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
IS-III active System_S-Narrow System is composed of IS-III active S-Narrow Type fixtures and Abutments. IS-III active Fixture S-Narrow Type is a thread type implant made of Titanium ELI according to ASTM F136 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex.
Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body.
The Fixture's diameters are 3.2 mm and the lengths are 8.5/10.0/11.5/ 13.0/ 15.0 mm. Tolerance of dimension shall be within ± 1% range.
IS-III active System S-Narrow Type Abutments are composed as below: IS Cover Screw, IS Healing Abutment, IS Cemented Abutment, IS Temporary Abutment and IS Abutment Screw
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K Number
K181137Device Name
IT-III active System
Manufacturer
Neobiotech Co., Ltd.
Date Cleared
2018-11-16
(200 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Neobiotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IT-III active system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. IT-III active system is dedicated for two stage surgical procedures and for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
IT-III active System is composed of Fixture and Abutments. IT-III active Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Octa. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The IT -III active System Abutment are composed as below; IT Cover screw, IT Healing Abutment, IT Solid Abutment, IT Excellent Solid Abutment, Protective Cap, IT Cemented Abutment, IT Pre Angled Abutment, IT Collared Abutment, IT Gold UCLA Abutment, IT Cemented Abutment Screw and IT Angled Abutment Screw.
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K Number
K181138Device Name
IS-III active System
Manufacturer
Neobiotech Co., Ltd.
Date Cleared
2018-10-03
(156 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Neobiotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IS-III active System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and terminal or internediate Abutment support for fixed bridgework. IS-III active System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
Device Description
IS-III active System is composed of IS-III active fixtures and Abutments. IS-III active Fixture is a thread type implant made of TI CP4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). There are 4 types of fixtures in this system and the dimensions are as following: Tolerance of dimension shall be within ± 1% range. IS-III active System Abutments are composed of IS Cover Screw, IS Healing Abutment, IS Encoded Healing Abutment, IS Solid Abutment, Protective Cap, IS Cemented Abutment, IS Shapable Abutment, IS Angled Abutment, IS Gold UCLA Abutment, IS Temporary Abutment, IS Ball Abutment, IS Ball Abutment Component (Housing, Retainer, O-ring) and IS Abutment Screw. The dimensions of abutments are as following: Tolerance of dimension for Abutments shall be within ± 1% range. The purpose of Anodizing for Cover Screw is to distinguish the sizes with the naked eyes for convenience. The surface of IS Solid, cemented, Shapable, Angled Abutments was treated with TiN-Coated. IS-III active Fixture, IS cover screw, and healing Abutments are provided sterilized. And other Abutments are provided non- sterilized. IS-III active Fixture is enclosed with Cover Screw in a packing. Other Abutments are enclosed with Abutment Screw in a packing. The Solid Abutment is enclosed with Protective cap. All of above products including enclosed product are packed separately for convenience.
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K Number
K181178Device Name
S-mini active Fixture
Manufacturer
Neobiotech Co., Ltd.
Date Cleared
2018-07-24
(83 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Neobiotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The S-mini active Fixture is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
Device Description
S-mini active Fixture is one body type mini implant which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Ti-6Al-4V ELI based on ASTM F136. The surface treatment of device is SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The feature of S-mini active fixture is one body implant which has thread body design include cutting edge for self-tapping. The fixtures' diameters and lengths are available as: Ø 2.5 mm (D) X 8.5/10.0/ 11.5/13.0/15.0mm (L), Ø 3.0 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L), Ø 3.5 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L). Tolerance of dimension shall be within ± 1% range. S-mini active Fixture is provided sterilized.
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K Number
K173938Device Name
IS-III HActive Fixture
Manufacturer
Neobiotech Co., Ltd.
Date Cleared
2018-05-24
(149 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Neobiotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IS-III HActive Fixture is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
IS-III HActive Fixture is composed of fixtures and cover screw. Fixtures are thread type implants made of titanium alloy which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Titanium Alloy based on ASTM F136. Surface treatment is HA Coating. This device has connection between the upper prosthesis and the internal hex. Surface is treated with RBM (Resorbable Blasting Media) using Hydroxyapatite powder. Residues are removed through a washing procedure after Plasma-spray with Hydroxyapatite and formation of the HA coating. It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The diameters are 3.5/4.0/4.5/5.0/6.0/7.0mm and the lengths are 7.3/ 8.5/10.0/ 11.5/13.0/15.0mm. (Do not offer 3.5 x 7.3mm implant, 6.0 x 15mm implant, or 7.0 x 15mm implant). Cover Screw intended to protect the inside of the implant during osseointegration. It is made of titanium alloy according to ASTM F136. The surface treatment of the cover Screw is anodizing or non-anodizing. The purpose of anodizing is to distinguish the sizes with the naked eyes for convenience. The diameter of cover screw is 3.45/3.6mm. IS-III HActive Fixture is enclosed with Cover Screw in a packing. IS-III HActive Fixture and Cover Screw can be packed separately for convenience.
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K Number
K160991Device Name
Neo GBR System
Manufacturer
NEOBIOTECH CO., LTD.
Date Cleared
2017-01-10
(277 days)
Product Code
DZL
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
NEOBIOTECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neo GBR System is intended to fixate and stabilize non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.
Device Description
The Neo GBR System is made of Titanium Alloy. This product is a sterilized single use medical device. This system consists of Tent screw and CTi Cover Screw. The function of the Tent Screw is temporarily Intraosseous Fixation Screw that places in the maxilla or mandible bone area to be combined with a titanium membrane of K 111761 and CT cover screw. Second surgery for removal is required. The product diameters are 2.0mm and the lengths are 7.2/8.7/10.2/11.7/13.2/15.2/18.2mm. The Tent Screw and CTi-Cover screw are always packaged together. But CTi-Cover Screw is packaged separately for the convenience. 4 pcs of Tent Screw can be packaged in a box as a bundle set.
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K Number
K120503Device Name
CMI IMPLANT IS II ACTIVE
Manufacturer
NEOBIOTECH CO., LTD.
Date Cleared
2012-06-18
(118 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
NEOBIOTECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CMI Implant IS II active is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
Neo CMI Implant IS II active system is dental implant consist of pure titanium, grade 4. The titanium implant surface was sandblasted with large grits and acid etched (S.L.A.) This implant system can be used for all oral endosteal implant indications in the mandible and maxilla, for functional and esthetic oral rehabilitation of edentulous. The fixture diameters are 3.8, 4.3, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0 and the lengths are 7.3, 8.5, 10.0, 11.5, 13.0, and 15.0.
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