DEVICE: ROEKO Calcium Hydroxide PLUS Points (E1653668970)

Device Identifier (DI) Information

ROEKO Calcium Hydroxide PLUS Points
ASSORTMENT ISO 45-80
In Commercial Distribution
366897
Coltène/Whaledent GmbH + Co. KG
E1653668970
HIBCC

1
315494443 *Terms of Use
No description.
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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
Root canal obturating point A metallic or polymeric based point or cone suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration.
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FDA Product Code

[?]
Product Code Product Code Name
EJK Liner, Cavity, Calcium Hydroxide
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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: less than 25 Degrees Celsius
Storage Environment Temperature: less than 77 Degrees Fahrenheit
Special Storage Condition, Specify: keep dry
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: ASSORTMENT contains ISO 45, ISO 50, ISO 55, ISO 60, ISO 70 and ISO 80
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Device Record Status

dede10ec-954b-4955-a9a4-7354bfb1cc59
March 29, 2018
2
August 23, 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

[?]
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

[?]
+4973458050
info.de@coltene.com
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