Search Results
Found 2 results
510(k) Data Aggregation
K Number
K190871Device Name
Bio-TackS Orthodontic Mini Implant
Manufacturer
Bio Cetec Co., Ltd.
Date Cleared
2020-01-17
(289 days)
Product Code
OAT
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Bio Cetec Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bio-TackS Orthodontic Mini Implant is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
Device Description
Fixed on jawbone the Bio-TackS Orthodontic Mini Implant is a screw-shaped product used as a fixed point for orthodontic treatment and it is applied in order to secure sufficient physical and mechanical fixing source for treatment.
Ask a Question
K Number
K182193Device Name
S-Line
Manufacturer
BIO CETEC CO., LTD.
Date Cleared
2019-01-22
(161 days)
Product Code
NJM
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
BIO CETEC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
S-Line™ orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position
Device Description
S-Line™ orthodontic ceramic bracket is used to treat malocclusion, the abnormal occlusion of the upper and the lower teeth. It is intended to be applied on the surface of teeth to restore dental esthetics and functionality and it is designed to be used jointly with orthodontic wire.
Ask a Question
Page 1 of 1