Restoration, orthodontic

Basic Information

• Brand Name: Restoration, orthodontic
• Primary DI: 06972677873147
• Version / Model: 314
• Company Name: Modern Dental Laboratory (DG) Co., Ltd.
• Labeler DUNS: 551746187
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2020-07-24
• Public Version: 4
• Public Version Date: 2024-10-21
• Public Version Status: Update
• Public Device Record Key: 1afc84f3-4036-490d-a011-1b156dc185cb

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSJ	Restoration, Noble Metal	Unknown		N
NSP	Restoration, Porcelain	Unknown		N
NSR	Prosthesis, Orthodontic	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	06972677873154	GS1
Primary	06972677873147	GS1