DEVICE: OSADA ENAC OE-505 (04580406860607)

Device Identifier (DI) Information

OSADA ENAC OE-505
OE-505
In Commercial Distribution
3151
OSADA ELECTRIC CO.,LTD.
04580406860607
GS1

1
690713813 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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?
47013 Dental ultrasonic surgical system generator
A mains electricity (AC-powered) component of a dental ultrasonic surgical system used to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch.
Active false
44906 Ultrasonic dental scaling/debridement system generator
A mains electricity (AC-powered) unit that functions as part of an ultrasonic dental scaling/debridement system, intended to generate, and enable control of, 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. It connects to the system handpiece, and may connect to a suitable water supply, or it may contain the water or rinsing solution (e.g., chlorhexidine) source.
Active false
47010 Dental ultrasonic surgical system
An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, and a foot-switch to regulate the energy. It is used for implant-site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty and osteotomy.
Active false
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

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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 [?]
K844250 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
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

151b3e05-7a98-41db-83d4-43a3bf1a7fb4
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
No
None
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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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