DEVICE: Advanced Dental System (00850309007251)

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Device Identifier (DI) Information
Advanced Dental System
90-2133D
In Commercial Distribution
90-2133D
ASI MEDICAL, INC.
00850309007251
GS1

1
808695159 *Terms of Use
Advanced Dental System
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
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GMDN

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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?
60930 Dental delivery system instrument unit, electric
A mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.
Active false
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FDA Product Code

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Product Code Product Code Name
LQY Locator, Root Apex
EKX Handpiece, Direct Drive, Ac-Powered
EKR Plugger, Root Canal, Endodontic
EFA Handpiece, Belt And/Or Gear Driven, Dental
EBZ Activator, Ultraviolet, For Polymerization
DZI Drill, Bone, Powered
EIA Unit, Operative Dental
ELC Scaler, Ultrasonic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K123139 000
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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 -40 and 70 Degrees Celsius
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
3f0f8ebb-966d-48c0-800b-a32dbcbd8714
July 06, 2018
3
October 31, 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

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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