DEVICE: SEPTODONT USA SEPTOETCH 12-1.6GM SYR (00303620000635)

Device Identifier (DI) Information

SEPTODONT USA SEPTOETCH 12-1.6GM SYR
01C2034
In Commercial Distribution
01C2034
SEPTODONT, INC
00303620000635
GS1

1
012925513 *Terms of Use
SEPTODONT USA SEPTOETCH 12-1.6GM SYR
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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
KLE Agent, Tooth Bonding, Resin
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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: between 10 and 24 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Weight: 1.5 Gram
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Device Record Status

d8e72511-e1a4-4879-982a-22d90090e77d
March 29, 2018
2
September 12, 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
No
No CLOSE

Customer Contact

[?]
(303) 665-7535
usregulatoryaffairs@septodont.com
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