FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TatumSurgical/HC ITI 3.7mm Integrity-Delrin HC for Integrity 3.7mm Implant
DI: 00083208003776
·
Model: Delrin Healing Cap for Integrity 3.7mm Implant
·
Suncoast Dental, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TatumSurgical/HC ITI 3.7mm Integrity-Delrin HC for Integrity 3.7mm Implant
- Primary DI
- 00083208003776
- Version / Model
- Delrin Healing Cap for Integrity 3.7mm Implant
- Catalog Number
- HC ITI 3.7mm Integrity
- Company Name
- Suncoast Dental, Inc
- Labeler DUNS
- 078352849
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-20
- Public Version
- 2
- Public Version Date
- 2020-06-01
- Public Version Status
- Update
- Public Device Record Key
- f0071dc0-c492-43f5-b3cb-2b03a20b3b0f
- Distribution End Date
- 2020-05-29
Device Description
HC ITI 3.7mm Integrity - Delrin Healing Cap for Integrity 3.7mm Implant
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44881 | Dental implant suprastructure kit | A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00083208003776 | GS1 |
Customer Contacts
- Phone
- +1(727)536-4880
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3.7 Delrin Healing Cap for Integrity 3.7mm Implant | ||
| Outer Diameter | 3.7 | Millimeter |