DEVICE: ACCESS (D798CH20)

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Device Identifier (DI) Information

ACCESS
CH2
CH2
RELIANCE ORTHODONTIC PRODUCTS INC
D798CH20
HIBCC
1
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
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No
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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
Dry-field dental retractor A preassembled device used in orthodontic and restorative dentistry designed to be placed around and inside a patient’s oral cavity to provide the operator with easy access to the field of operation by holding the mouth open and displacing the tongue; it typically allows suction tubing to be connected to permit saliva removal for maintaining a dry oral cavity during treatment procedures (e.g., bonding orthodontic brackets, bleaching, applying veneers or pit and fissure sealants). It is in the form of a synthetic polymer frame and typically consists of cheek retractors, a tongue guard, suction adaptors, and tubing with Y-piece connection to a suction system. 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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Sterilization

No
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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 Status

In Commercial Distribution
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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