DEVICE: Stoneglass Industries (D101SGI770)
Device Identifier (DI) Information
Stoneglass Industries
SGI77
In Commercial Distribution
SGI77
STONEGLASS DENTAL LABORATORY PTY LTD
SGI77
In Commercial Distribution
SGI77
STONEGLASS DENTAL LABORATORY PTY LTD
Complete acrylic denture with polished and glazed gingival contouring
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? |
---|---|---|---|---|
11172 | Preformed complete denture |
A prefabricated plastic plate designed to fit over an edentulous maxillary or mandibular alveolar ridge; an entire complement of artificial teeth from one arch is added to create a full denture. It is available in several standard sizes that can be contoured to custom fit the patient's ridge.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NSL | Dentures, Full |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b497c1e0-de4c-473d-bb9d-55f63f682dc9
May 05, 2022
1
April 27, 2022
May 05, 2022
1
April 27, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+61297641036
pdc@stoneglass.com.au
pdc@stoneglass.com.au