DEVICE: Henry Schein (00304040005477)

Device Identifier (DI) Information

Henry Schein
1047975
In Commercial Distribution
1047975
HENRY SCHEIN, INC.
00304040005477
GS1

1
012430880 *Terms of Use
Acclean Pro Ultrasonic Scaler
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
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
Rotary dental scaler An abrasive device intended to be attached to a powered dental handpiece that provides rotation and is used to remove calculus deposits and other accretions from tooth surfaces during dental cleaning and periodontal (gum) therapy. This is a reusable device.
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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 [?]
K954820 000
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: No
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

45db846a-bcdb-43a4-85dc-5171d328adba
July 06, 2018
3
September 24, 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
No Package DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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