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TatumSurgical/ITO HC 8.0 (CB)-Delrin HC for 8.0 One-Piece (CB)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- TatumSurgical/ITO HC 8.0 (CB)-Delrin HC for 8.0 One-Piece (CB) FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- ITO HC 8.0 (CB) - Delrin Healing Cap for 8.0 One-Piece (CB) FDA UDI
- Model / Reference
- Delrin Healing Cap for 8.0 One-Piece (CB) FDA UDI
- Description
- ITO HC 8.0 (CB) - Delrin Healing Cap for 8.0 One-Piece (CB) FDA UDI
Identifiers
- Catalog Number
- ITO HC 8.0 (CB) FDA UDI
- Primary DI / UDI-DI
- 00083208100802 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 8 Millimeter FDA UDI
TatumSurgical/ITO HC 8.0 (CB)-Delrin HC for 8.0 One-Piece (CB) by Suncoast Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Suncoast Dental, Inc.
Sources (1)
- FDA UDI a8663b14-31bb-4dd8-a93c-fe75b8c1e815 37 fields · synced May 30, 2026