DEVICE: Roydent (D8095031)

Device Identifier (DI) Information

Roydent
503
In Commercial Distribution
503
ROYDENT DENTAL PRODUCTS INC
D8095031
HIBCC

1
131487225 *Terms of Use
REFORM TEMP. C&B MATERIAL B1
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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, temporary A prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].
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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

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Storage and Handling
Special Storage Condition, Specify: Store in a Cool Dry Place
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Clinically Relevant Size

[?]
Size Type Text
Weight: 75 Gram
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Device Record Status

4676871a-3aa7-44fa-8b19-15d064c2c139
March 29, 2018
2
October 07, 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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)992-7767
info@roydent.com
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