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TatumSurgical/5.0x5.0mm Integrity Platform Switch Healing Cuff
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- TatumSurgical/5.0x5.0mm Integrity Platform Switch Healing Cuff FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- 5.0 x 5mm Integrity Platform Switch Healing Cuff FDA UDI
- Model / Reference
- 5.0x5.0mm Integrity PS-HC FDA UDI
- Description
- 5.0 x 5mm Integrity Platform Switch Healing Cuff FDA UDI
Identifiers
- Catalog Number
- HCS-ITI-PS 5.0x5.0mm FDA UDI
- Primary DI / UDI-DI
- 00083208500565 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use 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
- Height — 5 Millimeter FDA UDIOuter Diameter — 5 Millimeter FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
TatumSurgical/5.0x5.0mm Integrity Platform Switch Healing Cuff by Suncoast Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
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 2b0141d0-1334-4b17-a3d9-caa67ef75019 36 fields · synced Jun 8, 2026