DEVICE: S/ETCH (DO3681000451)

Device Identifier (DI) Information

S/ETCH
S/ETCH 10X2ML SYR KT
In Commercial Distribution
8100045
SDI LIMITED
DO3681000451
HIBCC

10
753221852 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
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 etching solution An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
EBF MATERIAL, TOOTH SHADE, RESIN
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K941899 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Handling Environment Atmospheric Pressure: between 10 and 25 Degrees Celsius
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Clinically Relevant Size

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

ee7d1911-30c7-47ae-a7af-2eafdca61f5a
July 06, 2018
3
September 27, 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: DO3681000450 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+18002285166
info@sdi.com.au
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