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510(k) Data Aggregation
K Number
K170104Device Name
COMPACT S, COMPACT S (LED)
Manufacturer
DMETEC CO., LTD.
Date Cleared
2017-12-27
(349 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
DMETEC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- removing supra and subgingival calculus and stains
- periodontal pocket lavage with simultaneous ultrasonic tip movement
- scaling and root planning
- releasing crowns, bridges, inlays and posts as well as condensing gutta percha
- plugging for amalgam condensation
- amalgam burnishing
- preparing, cleanig, and irrigating root canals
- preparing approximal cavites
- cementing inlays and onlays
- retrograde preparation of root canals
Device Description
The purpose of the device is to remove plaque from the surface of the tooth through using ultrasonic vibration generated by the electricity(24 V ~) and water supply received in a dental chair and other dental devices.
The product is provided in the form of parts that can be installed and used inside a dental chair and other dental devices. The control of the water supply is made from the dental chair and other dental devices.
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K Number
K121620Device Name
ULTRASONIC SURGERY
Manufacturer
DMETEC CO., LTD.
Date Cleared
2012-12-11
(193 days)
Product Code
DZI
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
DMETEC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
Device Description
This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside
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K Number
K113152Device Name
ULTRASONIC SURGERY MACHINE
Manufacturer
DMETEC CO., LTD.
Date Cleared
2012-06-14
(233 days)
Product Code
DZI
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
DMETEC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A device intended for use surgical procedure Including osteotomy, osteoplasty, Periodontal surgery and implantation
Device Description
This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside
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K Number
K060171Device Name
CLEANSE S+ ULTRASONIC SCALER
Manufacturer
DMETEC CO., LTD.
Date Cleared
2006-03-29
(65 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
DMETEC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use during dental procedures to:
-Remove supra and subgingival calculus and stains
- Remove ouple and Subge with simultaneous ultrasonic tip movement
- Scaling and root planning
- Releasing crowns, bridges, inlays and posts as well as condensing gutta percha
- Plugging for amalgam condensation
- Amalgam burnishing
- Preparing, cleaning, and irrigating root canals
- Preparing approximal cavities
- Cementing inlays and onlays
- Retrograde preparation of root canals
Device Description
The Cleanse S+ is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls for water flow and ultrasonic intensity, displays, and ultrasonic generator. The device is connected directly to a water supply for irrigation during use. A footswitch used for on/off control is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord. Instruments (stainless steel tips) designed for specific dental procedure are attached to the distal end of the handpiece.
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K Number
K051571Device Name
SKYLIGHT LED CURING LIGHT
Manufacturer
DMETEC CO., LTD.
Date Cleared
2005-07-19
(35 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
DMETEC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Skylight LED Curing Light is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding, and sealing materials that are photo-polymerized in the 440-490 nm waveband of visible light.
Device Description
Skylight by DMETEC Co., Ltd is classified as an Ultraviolet Activator for polymerization(21 C.F.R. 872.6070) because it is a device intended for the photo-polymerization light cured dental materials.
The Skylight is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 440 to 490 nm waveband of spectrum with a power density comprised 1,000W/cif, 13-11mm light quide.
These power densities are sufficient for photo-polymerization in the 440-490nm waveband of visible light cured (VLC) dental materials of restorative composite, orthodontic brackets, orthodontic bonding and sealing.
The exposure time can be set by one second to 99 seconds with 3 modes of operation: Standard, Pulse, and Soft Start. It has also memory storage functions for 5 exposure programs set by the practitioner.
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