DEVICE: Inspire™ Esthetic Provisional Composite A2 (07540172010757)

Device Identifier (DI) Information

Inspire™ Esthetic Provisional Composite A2
152076
In Commercial Distribution
152076
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
07540172010757
GS1

1
626406016 *Terms of Use
Crown and Bridge Temporary Resin
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental crown/bridge resin, temporary A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.
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FDA Product Code

[?]
Product Code Product Code Name
EBG CROWN AND BRIDGE, TEMPORARY, RESIN
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 64 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 18 and 25 Degrees Celsius
Special Storage Condition, Specify: Store in a dry place at room temperature; do not expose to sunlight and avoid exposure to extreme temperature fluctuations. Do not store in refrigerator.
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 10 Milliliter
Device Size Text, specify: syringe
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Device Record Status

e6e143c8-87a3-47c1-9bdd-a9a2f23c9066
March 29, 2018
2
September 16, 2016
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)265-3444
info@clinicianschoice.com
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