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Sterngold Implant System Bone Mill Guide Pin - TRU NP
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Sterngold Implant System Bone Mill Guide Pin - TRU NP FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Used to remove an area of crestal bone around the implant to make room for an abutment. FDA UDI
- Model / Reference
- 905809 FDA UDI
- Description
- Used to remove an area of crestal bone around the implant to make room for an abutment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549119033 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Fixture/appliance dental drill bit, 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fixture/appliance dental drill bit, reusable
Sterngold Implant System Bone Mill Guide Pin - TRU NP by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, reusable.
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- Prima — Keystone Dental Inc. · Class I
- Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Stopper Drill — Megagen Implant 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 I | Pending data |
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Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI 8b8c7385-e740-4a80-8da1-dc4cb4b76eb6 34 fields · synced May 30, 2026