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TatumSurgical/Integrity 2.0mm Abutment RH Screw for 3.7-5.0mm Implants
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- TatumSurgical/Integrity 2.0mm Abutment RH Screw for 3.7-5.0mm Implants FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- Integrity 2.0mm Abutment RH Screw for 3.7-5.0mm Implants FDA UDI
- Model / Reference
- 2.0 RH Integrity Abutment Screw FDA UDI
- Description
- Integrity 2.0mm Abutment RH Screw for 3.7-5.0mm Implants FDA UDI
Identifiers
- Catalog Number
- PITI-2.0 AS FDA UDI
- Primary DI / UDI-DI
- 00083208920004 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2 Millimeter FDA UDI
Category: Dental prosthesis/implant abutment screw
TatumSurgical/Integrity 2.0mm Abutment RH Screw for 3.7-5.0mm Implants by Suncoast Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Dental prosthesis/implant abutment screw.
- Azure — TERRATS MEDICAL SL. · Class II
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
- Implant Prosthetics — PREAT Corporation · Class II
- INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
- MEDENTiKA — Medentika GmbH · Class II
- Azure — TERRATS MEDICAL SL. · Class II
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 39204ada-3fb5-4ec3-9c46-e55ca2eaa3d3 36 fields · synced May 31, 2026