DEVICE: Affinity™ Inflex RS Mega Mix 380ml (07540172000031)
Device Identifier (DI) Information
Affinity™ Inflex RS Mega Mix 380ml
012380
In Commercial Distribution
012380
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012380
In Commercial Distribution
012380
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
VPS Impression Tray Material
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
35866 | Silicone dental impression material |
An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELW | MATERIAL, IMPRESSION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Min Relative Humidity. Ensure Adequate Ventilation |
Storage Environment Temperature: between 18 and 24 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 380 Milliliter |
Device Size Text, specify: cartridge |
Device Record Status
78bc83ca-f737-4776-af5b-eb2553a9890c
March 12, 2019
3
September 16, 2016
March 12, 2019
3
September 16, 2016
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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)265-3444
info@clinicianschoice.com
info@clinicianschoice.com