DEVICE: 3 x 13mm Simpli Simpler One Piece GBAE Dental Implant (D780S1S53130)
Device Identifier (DI) Information
3 x 13mm Simpli Simpler One Piece GBAE Dental Implant
S1S 5313
In Commercial Distribution
S1S 5313
Simpler Implant Solutions Inc
S1S 5313
In Commercial Distribution
S1S 5313
Simpler Implant Solutions Inc
3 x 13mm Simpli Simpler One Piece Hydroxylapatite Coated (HA) Dental Implant for Crown and Bridge
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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55848 | 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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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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DZE | Implant, Endosseous, Root-Form |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cbb4a583-dadf-4cb7-890f-2058a27bf53b
March 29, 2018
2
November 06, 2015
March 29, 2018
2
November 06, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-565-3559
simpler@simplerimplants.com
simpler@simplerimplants.com