DEVICE: SofScale™ (D003A900601)

Device Identifier (DI) Information

SofScale™
A90060
In Commercial Distribution

Dentsply Professional
D003A900601
HIBCC

1
144140845 *Terms of Use
SofScale™ Calculus Scaling Gel, Contents: 5 Syringes Scaling Gel (2mL) and 5 Disposable Application Tips
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental scaling solution A liquid substance used in dentistry to soften and partially solubilize a dental calculus (a hard deposit that forms on the teeth) before scaling mechanically so that less force is required, especially when teeth are loose. It will typically contain acid as a solvent (e.g., hydrochloric) and include other elements (e.g., iodine and excipients). After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
ELC Scaler, ultrasonic
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FDA Premarket Submission

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

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

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Storage and Handling
Storage Environment Temperature: between 5 and 25 Degrees Celsius
Special Storage Condition, Specify: Do not store at temperatures exceeding 25°C
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Clinically Relevant Size

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Size Type Text
Total Volume: 2 Milliliter
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Device Record Status

0f6739cf-48c4-47df-8350-5ec9495dc4bd
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
D003A900602 12 D003A900601 In Commercial Distribution Case
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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

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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

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+1(800)989-8825
xx@xx.xx
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