DEVICE: Roydent (D8097651)

Device Identifier (DI) Information

Roydent
765
In Commercial Distribution
765
ROYDENT DENTAL PRODUCTS INC
D8097651
HIBCC

150
131487225 *Terms of Use
BULK TO DYE FOR BLUE 150CT
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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 prosthesis dye A colouring intended to be used to stain a dental prosthesis (e.g., crown, bridge) before insertion in the patient to achieve a colour to match existing dentition. It is a mixture of inorganic chemicals typically used during the prosthesis manufacturing process. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
LFC DEVICE, CARIES DETECTION
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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
Special Storage Condition, Specify: Store in a Cool Dry Place
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 0.3 Milliliter
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Device Record Status

456f2096-5f7c-4e3c-9f6d-83247dbf909b
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

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

[?]
Unit of Use DI Number: D8097650 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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