DEVICE: AIR SOLFY (04548213016655)

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Device Record History
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Device Identifier (DI) Information
AIR SOLFY
AS2-4H-O V
In Commercial Distribution

J.MORITA MFG.CORP.
04548213016655
GS1

1
693811465 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
44909 Pneumatic dental scaling/debridement system handpiece
A holder for a detachable tip that functions as part of a pneumatic dental scaling/debridement system, designed to use compressed air to generate a vibrating action at the tip 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. Water is also fed through the handpiece and attached tip to assist in the process. It is typically designed with a standard 2-, 3-, or 4-hole connector utilizing the same connection to existing air-driven handpiece tubing and the water spray for lavage. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EFB Handpiece, Air-Powered, Dental
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K043497 000
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Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 70 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
7960c35a-9177-4246-9b67-1acbd1fa18ac
December 20, 2022
1
December 12, 2022
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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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