Restoration

Basic Information

• Brand Name: Restoration
• Primary DI: 06972677873369
• Version / Model: 336
• 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: 3
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: c97620ec-161f-4f84-920f-9b11361c798c

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
NSN	Restoration, Resin, Crown And Bridge	Unknown		N
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
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
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
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
38596	Custom-made dental crown, metal/polymer	A device made of metal, veneered with a polymer-based, tooth-coloured 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
38595	Custom-made dental crown, polymer	A device made entirely of polymer-based material with or without fibre reinforcement, 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
37543	Dental bridge, metal-polymer	A custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy with a tooth-coloured polymer material (veneer), 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
37542	Dental bridge, polymer	A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, 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
38649	Resin dental inlay	A custom-made dental restoration made of resin-based 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
38614	Dental bridge, metal-ceramic	A custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy combined with tooth-coloured ceramic material (veneer), 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
38593	Custom-made dental crown, metal/ceramic	A device made of a combination of metal and tooth-coloured ceramic, 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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	06972677873376	GS1
Primary	06972677873369	GS1