DEVICE: Park Dental Research Corp. (D7692010CO0)

Device Identifier (DI) Information

Park Dental Research Corp.
2010-CO
In Commercial Distribution

PARK DENTAL RESEARCH CORP
D7692010CO0
HIBCC

1
011441508 *Terms of Use
2.0 mm X 10mm LEW Mini Implant Collared
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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
Screw endosteal dental implant, one-piece A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.
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FDA Product Code

[?]
Product Code Product Code Name
DZE Implant, Endosseous, Root-Form
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121707 000
No CLOSE

Sterilization

Yes
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

824cb091-2d4c-4fdd-b8a9-8dab525e6acc
July 06, 2018
3
September 14, 2015
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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

[?]
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
Yes
No
No CLOSE

Customer Contact

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