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510(k) Data Aggregation
K Number
K231210Device Name
DGA Abutment
Manufacturer
Date Cleared
2024-03-05
(313 days)
Product Code
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Modern Dental Laboratory (DG) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DGA Abutment is a patient-specific prosthetic component directly connected to the endosseous dental implant (details as below) and is intended for use as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Device Description
DGA Abutment is endosseous implant abutment which is placed into a corresponding dental implant to provide support for a prosthetic restoration. DGA Abutment is made of titanium grade Ti-6Al-4V ELI (meets ASTM Standard F136). The DGA Abutment is mounted on the implant with a screw. Each abutment is supplied with two identical screws which are used for:
a. For fixing into the endosseous implant.
b. For dental laboratory use during fabrication of restoration.
The screw is also made of titanium grade Ti-6AI-4V ELI (meets ASTM Standard F136).
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K Number
K231884Device Name
TRIOCLEAR System
Manufacturer
Date Cleared
2023-09-01
(66 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Modern Dental Laboratory (DG) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TRIOCLEAR System is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of increment, it sequentially positions teeth by way of continuous gentle force.
Device Description
The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
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