DEVICE: Disposable Prophy Angles (D798DPA1)

Device Identifier (DI) Information

Disposable Prophy Angles
DPA
In Commercial Distribution
DPA
RELIANCE ORTHODONTIC PRODUCTS INC
D798DPA1
HIBCC

144
113170088 *Terms of Use
Disposable prophy angles are intended for use with Prophy Paste to clean, polish and restore enamel surfaces. Qty 144 per Box
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental polishing cup, single-use A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
EHK Cup, Prophylaxis
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Limitation: Store at ambient conditions
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

dcbf0fb4-3490-4caf-84fa-33dc6ea79951
March 29, 2018
2
August 10, 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

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Unit of Use DI Number: D798DPA0 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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