DEVICE: A.S.A.P. All Surface Access Polishers Indirect+ Intraoral Pre-Polisher Refill (07540172015752)

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Device Record History
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Device Identifier (DI) Information
A.S.A.P. All Surface Access Polishers Indirect+ Intraoral Pre-Polisher Refill
130920
In Commercial Distribution
130920
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
07540172015752
GS1

1
626406016 *Terms of Use
Dental abrasive point, re-usable
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
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?
35807 Dental abrasive disk, reusable
A dental instrument consisting of a circular flat or slightly conical sheet carrying or containing an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EHJ DISK, ABRASIVE
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
713f3e1e-2662-4224-a8a5-ddcddb0dc923
March 27, 2020
1
March 19, 2020
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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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)265-3444
info@clinicianschoice.com
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