Identity
- Trade Name
- Fixture Pin FDA UDI
- Generic Name
- Dental implantation depth/angle gauge, reusable FDA UDI
- Model / Reference
- OSFPXS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800011264871 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implantation depth/angle gauge, reusable 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implantation depth/angle gauge, reusable
Fixture Pin by POINTIMPLANT Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implantation depth/angle gauge, reusable.
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- Parallel Pin — OSSTEM IMPLANT Co., Ltd. · Class I
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- Tatum Socket Guide 4.5mm — SUNCOAST DENTAL, INC. · 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 |
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Manufacturer
- Manufacturer
- POINTIMPLANT Co., Ltd.
Sources (1)
- FDA UDI 7aaacdcd-e019-47ed-b3fc-d768245cebbd 32 fields · synced May 31, 2026