Identity
- Trade Name
- TRUFIX Bone Fixation System FDA UDI
- Generic Name
- Dental implantation drilling template retention pin FDA UDI
- Device Name
- truTACK 2.5HD 5TL 10/PK THREADED HX TI STERILE (6AL4VELI) FDA UDI
- Model / Reference
- 9600314 FDA UDI
- Description
- truTACK 2.5HD 5TL 10/PK THREADED HX TI STERILE (6AL4VELI) FDA UDI
Identifiers
- Catalog Number
- 9600314 FDA UDI
- Primary DI / UDI-DI
- 00614950007073 FDA UDI
- 510(k) Number
- K951392 FDA UDI
- FDA Product Code
- OAT FDA UDI
- GMDN Term
- Dental implantation drilling template retention pin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 5 Millimeter FDA UDI
Category: Dental implantation drilling template retention pin
TRUFIX Bone Fixation System by Ace Surgical Supply Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implantation drilling template retention pin.
- Anchor Screw — OSSTEM IMPLANT Co., Ltd. · Class I
- DS Implants — Dentsply Implants Manufacturing GmbH · Class I
- Paltop — Paltop Advanced Dental Solutions, Ltd. · Class I
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- ANKYLOS® — Dentsply Implants Manufacturing GmbH · Class I
- Anchor Screw — OSSTEM IMPLANT Co., Ltd. · Class I
- GuidedSMILE — GUIDED SMILE · Class I
- OneGuide Anchor Pin — OSSTEM IMPLANT Co., Ltd. · Class I
Cleared under the same submission
K951392 also covers:
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., 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 II | Pending data |
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Manufacturer
- Manufacturer
- Ace Surgical Supply Co., Inc.
Sources (1)
- FDA UDI 93f34482-4770-47aa-b240-60edba0905eb 37 fields · synced May 29, 2026