FDA UDI
In Commercial Distribution
🇺🇸 United States
Tatum Tapered Implant Master Kit
DI: 00083208022227
·
Model: Master Tapered Implant Kit
·
Suncoast Dental, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tatum Tapered Implant Master Kit
- Primary DI
- 00083208022227
- Version / Model
- Master Tapered Implant Kit
- Catalog Number
- ASY Tapered 2017 MSTR Kit
- 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
- fb33dd5b-19b5-4798-902d-72f1c7b86225
Device Description
Tatum tapered Implant kit: A kit designed for simplicity and ease of use in placing Tatum Tapered Implants 3.5-8.0mm: Kit Includes: DR1.5 Pilot drill, DR2.0 Pilot drill, DR3.5x11, 14, 17, 20, DR4.0x11, 14, 17, 20, DR4.5x11,14,17, 20, DR5.0x11, 14, 17, 20, DR6.0x11,14,17,20. DR7.11, 14,17. DR8.0x11, 14, 17. HT.02, 03, 04, 05, 06, 07, 08, 09, 10, 11. Tatum Ratchet. Post Guide PG.0, 10, 20, 30. Socket guides SG.33T, 38T, 43T, 48T. 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 | 00083208022227 | GS1 |
Customer Contacts
- Phone
- 727-536-4880
- [email protected]