FDA UDI
In Commercial Distribution
🇺🇸 United States
Bone Expander Screw Kit
DI: 00083208005558
·
Model: Bone Expander Screw Kit
·
Suncoast Dental, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bone Expander Screw Kit
- Primary DI
- 00083208005558
- Version / Model
- Bone Expander Screw Kit
- Catalog Number
- Bone Expander Screw Kit (5)
- Company Name
- Suncoast Dental, Inc
- Labeler DUNS
- 078352849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-03
- Public Version
- 2
- Public Version Date
- 2021-05-31
- Public Version Status
- Update
- Public Device Record Key
- c580c722-31a7-4962-b000-2565063cbee4
Device Description
Bone Expander Screw Kit (5). Contains 2.6, 3.0, 3.4, 3.8 and 4.3mm Expanders, Ratchet Wrench, Ratchet Extender, Latch Grip Adapter, Thumb Wrench, and Box Used to create an osteotomy for Implant placement.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 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 | 00083208005558 | GS1 |
Customer Contacts
- Phone
- (727) 536-4880
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141764 | 000 |