Identity
- Trade Name
- Tatum Surgical Integrity FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- Integrity Open Tray Transfer Screw 2.0mm, Fits transfers 3.7-4.5 & 5.0mm FDA UDI
- Model / Reference
- Analog ITI-OT XFer Screw 2.0 FDA UDI
- Description
- Integrity Open Tray Transfer Screw 2.0mm, Fits transfers 3.7-4.5 & 5.0mm FDA UDI
Identifiers
- Catalog Number
- Analog ITI-OT XFer Screw 2.0 FDA UDI
- Primary DI / UDI-DI
- 00083208920028 FDA UDI
- 510(k) Number
- K811923 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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 — 2.0 Millimeter FDA UDI
Category: Dental prosthesis/implant abutment screw
Tatum Surgical Integrity by Suncoast Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw.
- Azure — TERRATS MEDICAL SL. · Class II
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- 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
Cleared under the same submission
K811923 also covers:
- O-Ring small Black — SUNCOAST DENTAL, INC.
- Tatum Surgical Integrity — SUNCOAST DENTAL, INC.
- Tatum Surgical-Analog — SUNCOAST DENTAL, INC.
- Tatum Surgical-Analog — SUNCOAST DENTAL, INC.
- Tatum Surgical-Analog — SUNCOAST DENTAL, INC.
- Tatum Surgical-Analog — SUNCOAST DENTAL, INC.
- Tatum Surgical-Analog — SUNCOAST DENTAL, INC.
- Tatum Surgical-Analog — SUNCOAST DENTAL, INC.
- Tatum Surgical/Abutment (Post) — SUNCOAST DENTAL, INC.
- Tatum Surgical/Abutment (Post) — SUNCOAST DENTAL, INC.
- Tatum Surgical/Abutment (Post) — SUNCOAST DENTAL, INC.
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Suncoast Dental, Inc.
Sources (1)
- FDA UDI 85cc1a76-6df0-488c-8178-8e4888bdadbb 37 fields · synced May 30, 2026