FDA UDI
In Commercial Distribution
🇺🇸 United States
Tatum One Piece Implant Kit
DI: 00083208111112
·
Model: Standard One Piece Implant Kit 3.0-3.5
·
Suncoast Dental, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tatum One Piece Implant Kit
- Primary DI
- 00083208111112
- Version / Model
- Standard One Piece Implant Kit 3.0-3.5
- Catalog Number
- ASY One-Piece Kit Base
- Company Name
- Suncoast Dental, Inc
- Labeler DUNS
- 078352849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-31
- Public Version
- 1
- Public Version Date
- 2020-08-10
- Public Version Status
- New
- Public Device Record Key
- 8e0771fd-be81-4c59-addc-6904083a7ee1
Device Description
Tatum One Piece Implant kit: A kit designed for simplicity and ease of use in placing Tatum One Piece Implants: Kit Includes: DR1.5 Pilot drill, DR2.0 Pilot drill, DR3.0x14, DR3.5x14. HT.02, 12, 13, 14, 15, 20, 21, 31 & 32. Tatum Ratchet. Autoclaveable Cassette/Container for all pieces.
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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55847 | Dental implant system | A collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00083208111112 | GS1 |
Customer Contacts
- Phone
- 727-536-4880
- [email protected]