Identity
- Trade Name
- Tatum Paralleling Pin FDA UDI
- Generic Name
- Dental implantation depth/angle gauge, reusable FDA UDI
- Device Name
- Tatum Paralleling Pin : to check osteotomies are parallel. FDA UDI
- Model / Reference
- Paralleling Pin FDA UDI
- Description
- Tatum Paralleling Pin : to check osteotomies are parallel. FDA UDI
Identifiers
- Catalog Number
- Paralleling Pin FDA UDI
- Primary DI / UDI-DI
- 00083208400001 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Dental implantation depth/angle gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implantation depth/angle gauge, reusable
Tatum Paralleling Pin by Suncoast Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implantation depth/angle gauge, reusable.
- SCHWERT — A. Schweickhardt GmbH & Co. KG · Class I
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC. · Class I
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- Parallel Pin — OSSTEM IMPLANT Co., Ltd. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
- Neoss Implant System — Neoss, 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Suncoast Dental, Inc.
Sources (1)
- FDA UDI 9e5f8cd9-f25a-4dad-b810-ca2c56d2d88d 35 fields · synced May 30, 2026