Identity
- Trade Name
- DIRECTguide™ Guided Surgery Kit - Legacy FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- "Drills & Tools (Qty 51) Tray (Qty 1)" FDA UDI
- Model / Reference
- GSK-L FDA UDI
- Description
- "Drills & Tools (Qty 51) Tray (Qty 1)" FDA UDI
Identifiers
- Catalog Number
- GSK-L FDA UDI
- Primary DI / UDI-DI
- 10841307131021 FDA UDI
- 510(k) Number
- K231087 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
DIRECTguide™ Guided Surgery Kit - Legacy by Implant Direct Sybron Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
- Dental Elevator Combo Set — SONTEC INSTRUMENTS, INC. · Class I
- Positioning Guide Full KIT — OSSTEM IMPLANT CO., LTD. · Class IIa
- Implantium, Superline — Dentium Co., Ltd. · Class I
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- Ditron Dental — DITRON DENTAL LTD · Class I
- KLOCKNER — SOADCO, S.L. · Class II
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Osteo KIT — OSSTEM IMPLANT Co., Ltd. · Class I
Cleared under the same submission
K231087 also covers:
- DIRECTguide™ Bone Level Drill - 3.8 — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- DIRECTguide™ Bone Level Drill - 4.8 — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- DIRECTguide™ Guided Pin/Pilot Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- DIRECTguide™ Guided Start Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- DIRECTguide™ Guided Step Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- DIRECTguide™ Guided Step Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- DIRECTguide™ Guided Step Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- DIRECTguide™ Guided Step Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- DIRECTguide™ Guided Step Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- DIRECTguide™ Guided Step Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- DIRECTguide™ Guided Step Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- DIRECTguide™ Guided Step Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
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
- Implant Direct Sybron Manufacturing Llc
Sources (1)
- FDA UDI 5f6e739c-ce93-4945-8a17-5bf31e6c022f 36 fields · synced May 30, 2026