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510(k) Data Aggregation
K Number
K231864Device Name
Fiber Optic Brushless Electronic Micromotor, model: iM100
Manufacturer
Codent Technical Industry Co., Ltd.
Date Cleared
2024-03-11
(259 days)
Product Code
EBW
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Codent Technical Industry Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fiber Optic Brushless Electric Micromotor Set (iM100) is a brushless DC electric micromotor controlled by a control unit. It is intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. It is indicated for use in the field of preventive applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.
Device Description
The Fiber Optics Brushless Electric Micromotor Set, which model is iM100, is an electric device system comprised of brushless electric motor, control box, motor cord, and AC adapter. The Fiber Optics Brushless Electric Micromotor Set is designed to accommodate equal speed, gear-reduction speed, or gear-increasing speed handpiece attachment for the purpose of performing dental restoration procedures. Brushless electric motor utilize Permanent Magnet Synchronous Motor (PMSM) to offer stable torque, control box adjust the maximum speed and direction of brushless electric motor and show actual speed rate simultaneously, motor cord connect electric motor, control box and dental unit to offer handpiece water, air coolant and electricity. When equipped with the electric micromotor, the handpiece attachments provide the same effective drive force as would be provided by existing air motors. With motor control technology allows handpieces regardless of the front-end dental treatment operations or exposure to different functional groups or dental restorative material, and the speed of the drill can be kept within a certain extent but not easily change the load that make brushless electric motor operation is more easily and efficiently, unlike the operation of the air motor handpiece need to keep relied dentist technical experience. The Fiber Optics Brushless Electric Micromotor Set could control the speed range from 2,000 to 40,000 rpm.
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K Number
K152146Device Name
High Speed Handpieces and Accessories
Manufacturer
CODENT TECHNICAL INDUSTRY CO., LTD.
Date Cleared
2015-12-08
(127 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
CODENT TECHNICAL INDUSTRY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
High Speed Handpieces and Accessories are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Device Description
High Speed Handpieces and Accessories include 45° High Speed Handpieces, 90° High Speed Handpieces and Couplings. The models of 45° High Speed Handpieces are A45series (A45L, A45, A45M4) and 90° High Speed Handpieces are A6series (A6KL, A6L, A6, A6M4, A6B2), A5series (A5KL, A5K, A5L, A5, A5M4, A5B2), A4series (A4, A4M4, A4B2), A3series (A3, A3M4, A3B2), E-6510series (E-6510K, E-6510N), E-6500series (E-6500K, E-6500N), E-6110series (E-6110K, E-6110N), E-6100series (E-6100K, E-6100N), HPXseries (HPX4CML-Ti, HPX4CQ, HPX4CQ-Ti), HPMseries (HPM1CML, HPM1CQ, HPM1C4, HPM1C2, HPM1S4, HPM1S2) and HPKseries (HPK1C2, HPK1S4, HPK1S2). And the accessories of High Speed Handpiece are Couplings, the models of Accessories are Q6series (Q6M, Q6M-LED, Q6K, Q6K-LED, Q6KW), Q5series (Q5K), Q4series (Q4K, Q4M, Q4Q), Q2series (Q2Q), CKseries (CK4010, CK4000) and CNseries (CN4010, CN4000).
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K Number
K150798Device Name
Codent Low Speed Dental Handpieces and Accessories
Manufacturer
CODENT TECHNICAL INDUSTRY CO., LTD.
Date Cleared
2015-04-24
(29 days)
Product Code
EFB, EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
CODENT TECHNICAL INDUSTRY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Codent Low Speed Dental Handpieces and Accessories are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Device Description
Codent Low Speed Dental Handpieces and Accessories include low speed air motor, straight handpiece and contra-angle handpiece. The gear ratios of handpieces are 1:5 and 1:1. The handpieces have maximum speed of 200,000 rpm and minimum speed of 40,000 rpm. The air motors are capable of running up to a speed of 25,000 rpm. AI6C and AI2C air motors can be connected to LEIPB1, LEIPA1, A11, A65L, A65, A61L and A61 handpieces; LAISA1, LBIPA1, LEIPD4 and LEIPC4 of Codent's FDA 510(k) K133069. E-1110 and E-1100 air motors can be connected to E-2000. E-4010 and E-4000 handpieces.
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K Number
K133069Device Name
CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES
Manufacturer
CODENT TECHNICAL INDUSTRY CO., LTD.
Date Cleared
2014-10-24
(389 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
CODENT TECHNICAL INDUSTRY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Codent Low Speed Dental Handpieces and Accessories are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Device Description
Codent Low Speed Dental Handpieces and Accessories include low speed air motor, straight handpiece and contra-angle handpiece. The Codent Low Speed Dental Handpieces and Accessories are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
The gear ratios of handpieces are 1:5 and 1:1, with the maximum speed of 200,000 rpm and 40,000 rpm. AI4C and AI2N air motors can be connected to LAISAI, LBIPA1, LEIPD4 and LEIPC4 hanpieces. AE4N and AE2N air motors can be connected to LAESA2 and LDEPA2 hanpieces. The 4 air motors are capable of running up to a speed of 25,000 rpm.
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K Number
K033213Device Name
CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS
Manufacturer
CODENT TECHNICAL INDUSTRY CO., LTD.
Date Cleared
2004-02-06
(126 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
CODENT TECHNICAL INDUSTRY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CODENT Dental Air-Powered Handpiece, model HPS is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Device Description
Dental Air-Powered Handpiece
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