| Primary Device ID | 00083208163333 |
| NIH Device Record Key | 0655fae3-ed52-449c-b97a-c3fcd4ae5e0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tatum EZ-Flex Periotome Kit |
| Version Model Number | Tatum EZ-Flex Periotome Kit |
| Catalog Number | Tatum EZ-Flex Periotome Kit |
| Company DUNS | 078352849 |
| Company Name | Suncoast Dental, Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00083208163333 [Primary] |
| EMJ | Elevator, Surgical, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00083208163333]
Moist Heat or Steam Sterilization
[00083208163333]
Moist Heat or Steam Sterilization
[00083208163333]
Moist Heat or Steam Sterilization
[00083208163333]
Moist Heat or Steam Sterilization
[00083208163333]
Moist Heat or Steam Sterilization
[00083208163333]
Moist Heat or Steam Sterilization
[00083208163333]
Moist Heat or Steam Sterilization
[00083208163333]
Moist Heat or Steam Sterilization
[00083208163333]
Moist Heat or Steam Sterilization
[00083208163333]
Moist Heat or Steam Sterilization
[00083208163333]
Moist Heat or Steam Sterilization
[00083208163333]
Moist Heat or Steam Sterilization
[00083208163333]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-10-07 |
| Device Publish Date | 2025-09-29 |
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| 00083208163333 - Tatum EZ-Flex Periotome Kit | 2025-10-07Tatum EZ-Flex Periotome Kit - for Atraumatic extraction of roots and teeth - Includes box and 8 Flexible Periotomes |
| 00083208163333 - Tatum EZ-Flex Periotome Kit | 2025-10-07 Tatum EZ-Flex Periotome Kit - for Atraumatic extraction of roots and teeth - Includes box and 8 Flexible Periotomes |
| 00083208191121 - Tatum Sinus Instrument Kit | 2024-10-03 Tatum double ended Sinus Instruments, Kit of 10, Inc. Surgical Instrument Tray |
| 00083208162220 - Tatum EZ Out Periotome E Kit | 2024-08-07 Tatum EZ Out Periotome E Kit - for Atraumatic extraction of roots and teeth - Inc box and 7 periotomes #1,#2, #3, #4, #5, #6, & |
| 00083208135002 - DDP Dental Mirror | 2024-02-07 Dental Mirror, reusable |
| 00083208136702 - DDP Extraction Forceps | 2024-02-07 Tooth Extraction Forceps 67A |
| 00083208452215 - Tatum Surgical IP Press Fit Abutment | 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 2.0mm Cuff Height |
| 00083208453212 - Tatum Surgical IP Press Fit Abutment | 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 3.0mm Cuff Height |