DEVICE: Denture, restoration (06972677873109)

Device Identifier (DI) Information

Denture, restoration
310
In Commercial Distribution

Modern Dental Laboratory (DG) Co., Ltd.
06972677873109
GS1

3
551746187 *Terms of Use
No description.
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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?
38588 Complete upper denture
A custom-made artificial replacement for all teeth in the upper jaw (maxilla) carried on a removable plate or frame which is supported by surrounding soft and hard tissues of the oral cavity. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)].
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38589 Complete lower denture
A custom-made artificial replacement for all teeth in the lower jaw (mandible) carried on a removable plate or frame which is supported by surrounding soft and hard tissues of the oral cavity. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)].
Active false
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.
Active false
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.
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
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FDA Product Code

[?]
Product Code Product Code Name
NSL Dentures, Full
NSO Restoration, Porcelain-Fused-To-Metal
NSP Restoration, Porcelain
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

32b10e7f-45d5-42a5-b80b-7c514b49a6ec
March 10, 2021
3
July 24, 2020
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 06972677873116 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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