DEVICE: Pro-Select Platinum® (D81320540)

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Device Record History
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Device Identifier (DI) Information
Pro-Select Platinum®
2054
In Commercial Distribution
2054
DEN-MAT HOLDINGS, LLC
D81320540
HIBCC

100
809857704 *Terms of Use
23-Gauge Sideport Irrigation Cannulas (100/box)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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?
36047 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).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ELC Scaler, Ultrasonic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K964596 000
No CLOSE

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

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

[?]
Size Type Text
No Device Sizes
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Device Record Status
6853f3df-485f-4e82-ade9-578754995a20
July 06, 2018
3
September 24, 2016
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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
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

[?]
Unit of Use DI Number: D813205400 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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