DEVICE: Park Dental Research Corp. (D769OMHP20)

Device Identifier (DI) Information

Park Dental Research Corp.
OMHP-2
In Commercial Distribution

PARK DENTAL RESEARCH CORP
D769OMHP20
HIBCC

1
011441508 *Terms of Use
Metal Housing Pink Single Pack
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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 anchor A device made of austenitic alloys or alloys containing 75 percent or greater gold (Au) or metals of the platinum group, intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.
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FDA Product Code

[?]
Product Code Product Code Name
NDP Accessories, Implant, Dental, Endosseous
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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
No storage/handling found
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Clinically Relevant Size

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

79a88039-00e6-488b-807e-20e8a7a1b72a
March 29, 2018
2
January 29, 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

[?]
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

[?]
1-800-243-7372
info@pdrus.com
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