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510(k) Data Aggregation
K Number
K173141Device Name
CSM Submerged3-L Implant System
Manufacturer
CSM Implant
Date Cleared
2018-09-19
(355 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
CSM Implant
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CSM Submerged3-L Implant System is intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.
Device Description
The CSM Submerged3-L Implant System is composed of dental fixtures (Sub3 Fixture) and various abutments such as Healing Abutment, Cementation Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Abutment Screw, Submerged Cover Screw, Retainer Abutment, Retainer Cap, Retainer Retention Male, and Temporary Abutment (Hex, Non-Hex). There is no vertical anti-rotation slot in our fixtures. When it comes to anti-rotational feature, it is 11 °, which is internal hexagonal feature. Hence. 4.0. 4.8. 5.2. 5.6. 6.0 size fixtures have 2.5 hexagonal features, different from fixture with 3.6 diameter, which has 2.1 double hexagonal feature. The fin of submerged 3 fixtures is V-shape. In addition, a straight flat axial surface is on our fixture, functioning as tapering part. In case of abutments, 2.5 and 2.1 hexagonal features are usually used. The Sub3 fixtures and screws are made of Ti 6A1 4V ELI (Conforming to ASTM Standard F-136) and dental abutment is made of Ti-6A1-4V ELI (ASTM F136), POLYAMIDE 6.6. The surface of the fixtures is treated with RBM (Resorbable Blast Media) and Laser. The diameters of the CSM Submerged3-L Implants are Ø 3.62mm, 4.35mm, 4.75mm, 5.15mm, 5.55mm, 5.95mm and the lengths of the CSM Submerged3-L Implants are 7.3mm, 8.3mm, 9.3mm, 10.3mm, 11.3mm, 12.3mm, 13.3mm, 14.3mm. The dimension of each abutment ranges as below: (The tolerance of all products is ±0.03) - Healing Abutment: Ø 4.02mm, 4.5mm, 6.5mm (D) X 8.25mm, 8.75mm, 9.75mm, ● 10.35mm, 10.75mm, 11.75mm, 12.35mm, 12.75mm (L) - Cementation Abutment: Ø 4.5mm, 5.5mm, 6.5mm (D) X 8.0mm, 8.5mm, 9.0mm, 9.5mm, ● 10.5mm, 11.5mm, 12.5mm, 13.5mm (L) - Angled Abutment: Ø 4.0mm, 4.5mm, 5.5mm (D) X 9.0mm, 9.5mm, 10.0mm, 10.3mm, ● 10.4mm, 10.5mm, 11.3mm, 11.5mm, 12.3mm, 12.3mm, 13.3mm, 13.5mm (L) with 15° and 20° - . Abutment Screw: Ø 2.1mm, 2.33mm (D) X 8.3mm, 10.0mm (L) - Submerged Cover Screw: Ø 2.83mm, 3.33mm (D) X 6.0mm, 6.5mm (L) ● - Retainer Abutment: Ø 3.9mm (D) X 7.15mm, 7.65mm, 7.9mm, 8.65mm, 8.9mm, ● 9.65mm, 9.9mm, 10.65mm, 10.9mm, 11.65mm, 11.9mm, 12.9mm, 13.65mm, 13.9mm, 14.65mm, 14.9mm, 15.65mm, 15.9mm, 16.65mm, 16.9mm (L) - Retainer Cap: Ø 5.45mm (D) X 2.4mm (L) ● - Retainer Retention Male: Ø 4.7mm (D) X 1.85mm, 2.06mm (L) ● - Temporary Abutment: Ø 4.5mm, 5.5mm (D) X 12.8mm, 13.8mm, 13.8mm, 14.8mm, 15.8mm, ● 16.8mm (L) The implant-abutment connection is internal hex and Morse taper level. Implant-fixture and submerged cover screw are packed together and provided sterile. The abutments are provided non-sterile and must be sterilized before use.
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K Number
K120043Device Name
CSM INTERNAL-R IMPLANT SYSTEM
Manufacturer
CSM IMPLANT
Date Cleared
2012-04-27
(113 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
CSM IMPLANT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CSM Internal-R Implant 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. This system is intended for delayed loading.
Device Description
The CSM Internal-R Implant System is intended for use in partial or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The CSM Internal-R Implant system contains two types of fixtures, straight and tapered type based on the shape of the fixture. This system is made from titanium (Ti-6AI-4V ELI) and the surface treatment is done with Resorbable hydroxyapatite Blast Medium.
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K Number
K102635Device Name
APOLONIA LASER IMPLANT SYSTEM
Manufacturer
CSM IMPLANT CO., LTD
Date Cleared
2011-03-22
(190 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
CSM IMPLANT CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CSM Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.
Device Description
The CSM submerged-L Implant System includes various one-stage Fixtures and two-stage Fixtures made of titanium. These implants are surgically inserted into the upper and/or lower jawbone and serve as a tooth root replacement providing a stable foundation for restorations. This product is a fixture and an abutment prosthetic dentistry material which are dental implant infrastructures. The connection with the abutment is inserted in bones as internal connection (the morse taper 11° and Hexagon type) method. A connection will restore mastication function of the patient who has difficulties due to damage of the natural tooth and function as a supporting the prosthetic dentistry material such as artificial tooth.
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