DEVICE: Roydent (D809PL2081)

Device Identifier (DI) Information

Roydent
PL208
In Commercial Distribution
PL208
ROYDENT DENTAL PRODUCTS INC
D809PL2081
HIBCC

1
131487225 *Terms of Use
ENDO CLEANSE 2oz. BOTTLE
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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
Root surface conditioner A dental material, typically of neutral pH, used for topical application on exposed/scaled root surfaces for the removal of the smear layer (adherent debris produced when cutting the enamel or dentin in cavity or endodontic preparation, Circa 1 micron thick) during dental/periodontal surgery. The material is removed (washed off) after the recommended period to expose the collagenous matrix of dentine surfaces. It is typically presented in the form of a gel and consists of, e.g., edetate disodium (EDTA) and carboxymethylcellulose (CMC) with a neutral pH. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
EKL POINT, SILVER, ENDODONTIC
KIF RESIN, ROOT CANAL FILLING
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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
Total Volume: 2 Fluid Ounce
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Device Record Status

b489f8c8-d4d1-47de-8c33-8ebfaec07e13
March 29, 2018
2
October 07, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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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