DEVICE: Well-Prep (08809254452236)

Device Identifier (DI) Information

Well-Prep
WE109-K000
In Commercial Distribution

VERICOM CO., LTD.
08809254452236
GS1

1
689698269 *Terms of Use
EDTA Root Canal Preparation Cream - Cleanser, Endodontic, Root Canal ; Well-Prep Blue 3g x 3 syringes
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34524 Dental tooth-cleaning solution
A liquid or gel substance intended to be applied by a dental professional to clean tooth surfaces/cavities, often prior to or following a dental procedure (e.g., restoration, implantation). It typically contains appropriate cleaning agents and may be formulated to prevent plaque accumulation and gingivitis. It is often applied with a syringe, which may be included. After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EKQ Preparer, Root Canal Endodontic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 27 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

500a6951-b5d3-4e80-9277-bb87fa5e888c
October 05, 2018
3
November 01, 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)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+82314412881
vericom@vericom.co.kr
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