DEVICE: Pro-Select Platinum® (D8131007730)

Device Identifier (DI) Information

Pro-Select Platinum®
100773
In Commercial Distribution
100773
DEN-MAT HOLDINGS, LLC
D8131007730
HIBCC

1
809857704 *Terms of Use
Tip Gauge/ Wrench
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Ultrasonic dental scaling/debridement system An assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).
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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 [?]
K964596 000
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Sterilization

No
Yes
Sterilization Method [?]
Liquid Chemical
Moist Heat or Steam Sterilization
High-level Disinfectant
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep away from explosive substances and flammable materials
Special Storage Condition, Specify: Do not use this product in presence of inflammable anesthetics or gases
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

d0cb28b0-f05f-4a40-a2e7-3560dad75e49
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)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-800-433-6628
info@denmat.com
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