DEVICE: Toms Sensitive + Whitening Fluoride-Free Toothpaste (20035000992974)

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Device Record History
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Device Identifier (DI) Information
Toms Sensitive + Whitening Fluoride-Free Toothpaste
61016024
In Commercial Distribution

TOM'S OF MAINE, INC.
20035000992974
GS1

1
829517189 *Terms of Use
Get sensitivity relief + whitening all in one mint toothpaste for your oral care routine. The amino acid arginine + calcium carbonate complex contains arginine to deliver sensitivity relief within 60 seconds.This natural formula provides 24/7 protection for sensitive teeth and safely whitens your teeth.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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?
35698 Dental cavity varnish
A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LBH Varnish, Cavity
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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
Special Storage Condition, Specify: No specific requirements
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
0a109444-fb08-4e50-996a-cf6eab93a074
January 15, 2025
3
June 02, 2023
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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
10035000992977 24 00035000992970 In Commercial Distribution Case
00035000992970 1 20035000992974 In Commercial Distribution Carton
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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

[?]
1-800-367-8667
xx@xx.xx
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