DEVICE: Lynx Scalemaster (D826LX3004H091)

Device Identifier (DI) Information

Lynx Scalemaster
LX3004H09
In Commercial Distribution

MTI Precision Products, LLC
D826LX3004H091
HIBCC

1
081600128 *Terms of Use
The Lynx Scalemaster in an ultrasonic scaler a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits for teeth by application of a sonic vibrating scaler tip to the teeth.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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 [?]
K901488 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

a00642d2-8962-4764-b5b9-34a487ac7ed9
July 06, 2018
3
September 22, 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
Yes
D826LX3004H090
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Production Identifier(s) in UDI

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No
Yes
No
No
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Customer Contact

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No Customer Contact currently defined
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