DEVICE: ACCESS (D798CH20)

Device Identifier (DI) Information

ACCESS
CH2
In Commercial Distribution
CH2
RELIANCE ORTHODONTIC PRODUCTS INC
D798CH20
HIBCC

1
113170088 *Terms of Use
The ACCESS™ Cheek Retractors are intended for use in pulling the cheeks back from the buccal and labial surfaces of the teeth during orthodontic procedures. Pediatric Size - Special posterior pads comfortably hold the cheeks away and allow excellent "accessibility" to the bicuspid and molar area. Spring stainless steel bow allows for adjustment and pivot points provide greater comfort.
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Device Characteristics

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

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

GMDN Preferred Term Name GMDN Definition
Dental cheek retractor, professional, reusable A hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
EIF Accessories, Retractor, Dental
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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

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Storage and Handling
Special Storage Condition, Specify: Store at ambient conditions
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

2c60062a-a680-435f-b3ab-4796b85c624b
October 05, 2018
3
July 25, 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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Yes
No
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No CLOSE

Customer Contact

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6307734009
paulgropi@aol.com
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