FDA UDI
In Commercial Distribution
🇺🇸 United States
Tatum EZ-Flex Periotome Kit
DI: 00083208163333
·
Model: Tatum EZ-Flex Periotome Kit
·
Suncoast Dental, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Tatum EZ-Flex Periotome Kit
- Primary DI
- 00083208163333
- Version / Model
- Tatum EZ-Flex Periotome Kit
- Catalog Number
- Tatum EZ-Flex Periotome Kit
- Company Name
- Suncoast Dental, Inc
- Labeler DUNS
- 078352849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-29
- Public Version
- 1
- Public Version Date
- 2025-10-07
- Public Version Status
- New
- Public Device Record Key
- 0655fae3-ed52-449c-b97a-c3fcd4ae5e0e
Device Description
Tatum EZ-Flex Periotome Kit - for Atraumatic extraction of roots and teeth - Includes box and 8 Flexible Periotomes
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMJ | Elevator, Surgical, Dental | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45713 | Periotome, reusable | A hand-held dental instrument intended to be used during tooth extraction/luxation to cut the periodontal ligament that binds the tooth to the surrounding marginal and alveolar bone (alveolar process), causing minimal mechanical trauma to the bone tissue. It is typically made of stainless steel and consists of a shaft that terminates in a single or double flat, sharpened blade that is straight, curved, or angled. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00083208163333 | GS1 |
Customer Contacts
- Phone
- 727-536-4880
- [email protected]