DEVICE: Restoration, orthodontic (06972677873147)
Device Identifier (DI) Information
Restoration, orthodontic
314
In Commercial Distribution
Modern Dental Laboratory (DG) Co., Ltd.
314
In Commercial Distribution
Modern Dental Laboratory (DG) Co., Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35858 | Dental casting noble alloy |
A material composed primarily of noble metals [e.g., gold (Au), palladium (Pd), platinum (Pt), or silver (Ag)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.
|
Active | false |
38591 | Custom-made dental crown, metal |
A device made totally of metal alloy material, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.
|
Active | false |
38648 | Gold dental inlay |
A custom-made dental restoration made of gold-based alloy that is bonded within the center of a tooth (intracoronal) typically to serve as a well-fitting, long-lasting alternative to dental fillings for tooth decay or similar damage. It is fabricated indirectly in a dental lab, sometimes by computer-aided design/computer-aided manufacturing (CAD/CAM) techniques, before being fitted and bonded to the damaged tooth. This is a single-use device.
|
Active | false |
38594 | Custom-made dental crown, ceramic |
A device made totally of ceramic material, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.
|
Active | false |
38615 | Dental bridge, ceramic |
A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of ceramic/porcelain material and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.
|
Active | false |
38647 | Ceramic dental inlay |
A custom-made dental restoration made of ceramic material that is bonded within the center of a tooth (intracoronal) typically to serve as a well-fitting, long-lasting alternative to dental fillings for tooth decay or similar damage. It is fabricated indirectly in a dental lab, sometimes by computer-aided design/computer-aided manufacturing (CAD/CAM) techniques, before being fitted and bonded to the damaged tooth. This is a single-use device.
|
Active | false |
38645 | Dental veneer, professional |
A custom-made dental restoration made of ceramic or polymer-based material (resin) intended to be used in aesthetic dentistry to correct the facial surface of a tooth; it is intended to be applied to the teeth by a dental professional for long-term use, typically via an adhesive. This is a single-use device.
|
Active | false |
36311 | Removable dental occlusal splint, preformed |
A rigid or flexible prefabricated device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporo-mandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is removable by the patient (e.g., during meals), and is typically made of standard, preformed materials that are not moulded, or intended to be moulded to a specific patient. This is a reusable device.
|
Active | false |
41678 | Orthodontic appliance system, bonded |
An assembly of custom-made and preformed devices such as metal bands, archwires, springs, screws, power arms and/or a base plate (framework), designed to be applied to the teeth to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Often referred to as dental braces, it is intended to remain in the oral cavity for the duration of the treatment, and may be periodically adjusted by an orthodontist to effect skeletal and/or dental changes. This is a single-use device.
|
Obsolete | false |
35310 | Orthodontic retainer |
An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NSJ | Restoration, Noble Metal |
NSP | Restoration, Porcelain |
NSR | Prosthesis, Orthodontic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
1afc84f3-4036-490d-a011-1b156dc185cb
October 21, 2024
4
July 24, 2020
October 21, 2024
4
July 24, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
06972677873154
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined