| Primary Device ID | 00083208550201 |
| NIH Device Record Key | a0341808-ac56-47cd-8205-ae289689006b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TatumSurgical/Screw Implant |
| Version Model Number | Screw/5.0 x 20 |
| Catalog Number | IS5.0x20 |
| Company DUNS | 078352849 |
| Company Name | Suncoast Dental, Inc |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(727)536-4880 |
| tatumimplants@verivon.net | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 20 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00083208550201 [Primary] |
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00083208550201]
Moist Heat or Steam Sterilization
[00083208550201]
Moist Heat or Steam Sterilization
[00083208550201]
Moist Heat or Steam Sterilization
[00083208550201]
Moist Heat or Steam Sterilization
[00083208550201]
Moist Heat or Steam Sterilization
[00083208550201]
Moist Heat or Steam Sterilization
[00083208550201]
Moist Heat or Steam Sterilization
[00083208550201]
Moist Heat or Steam Sterilization
[00083208550201]
Moist Heat or Steam Sterilization
[00083208550201]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-30 |
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| 00083208580116 | Screw Dental Implant 8.0mm in diameter and 11mm in length |
| 00083208570179 | Screw Dental Implant 7.0mm in diameter and 17mm in length |
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| 00083208560149 | Screw Dental Implant 6.0mm in diameter and 14mm in length |
| 00083208560118 | Screw Dental Implant 6.0mm in diameter and 11mm in length |
| 00083208550201 | Screw Dental Implant 5.0mm in diameter and 20mm in length |
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| 00083208550140 | Screw Dental Implant 5.0mm in diameter and 14mm in length |
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| 00083208545115 | Screw Dental Implant 4.5mm in diameter and 11mm in length |
| 00083208540202 | Screw Dental Implant 4.0mm in diameter and 20mm in length |
| 00083208540172 | Screw Dental Implant 4.0mm in diameter and 17mm in length |
| 00083208540141 | Screw Dental Implant 4.0mm in diameter and 14mm in length |
| 00083208540110 | Screw Dental Implant 4.0mm in diameter and 11mm in length |
| 00083208535208 | Screw Dental Implant 3.5mm in diameter and 20mm in length |
| 00083208535178 | Screw Dental Implant 3.5mm in diameter and 17mm in length |
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| 00083208580208 | Screw Dental Implant 8.0mm in diameter and 20mm in length |
| 00083208570209 | Screw Dental Implant 7.0mm in diameter and 20mm in length |
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