FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Tatum Surgical/One Piece small ball head implant
DI: 00083208280146
·
Model: One Piece/8.0x14SB
·
Suncoast Dental, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tatum Surgical/One Piece small ball head implant
- Primary DI
- 00083208280146
- Version / Model
- One Piece/8.0x14SB
- Catalog Number
- ITO8.0x14SB
- Company Name
- Suncoast Dental, Inc
- Labeler DUNS
- 078352849
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-18
- Public Version
- 2
- Public Version Date
- 2019-06-12
- Public Version Status
- Update
- Public Device Record Key
- 8bdc08f7-51f4-4e33-a534-5babca311784
- Distribution End Date
- 2019-06-11
Device Description
One Piece Dental Implant 8.0mm diameter and 14mm in length small ball head
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00083208280146 | GS1 |
Customer Contacts
- Phone
- +1(727)536-4880
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K811923 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | One Piece 8.0mm Diameter x 14mm Length SB | ||
| Outer Diameter | 8 | Millimeter | |
| Length | 14 | Millimeter |