DEVICE: 3.25mm x 15mm Simpler One Push in Implant HA (D780S150040)

Device Identifier (DI) Information

3.25mm x 15mm Simpler One Push in Implant HA
S1 5004
In Commercial Distribution
S1 5004
Simpler Implant Solutions Inc
D780S150040
HIBCC

1
203213343 *Terms of Use
3.5mm Diameter x 13mm length Simpler One Surgery Two Piece Hydroxylapatite (HA) coated Push in implant
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Device Characteristics

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

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
Screw endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.
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FDA Product Code

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

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

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 3.25 millimeters diameter x 15 millimeters length
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Device Record Status

b0eebd26-217f-4bc3-9825-8ab58d8c9f08
March 29, 2018
2
October 24, 2015
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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
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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