Identity
- Trade Name
- DirectGuide™ Drill Extender FDA UDI
- Generic Name
- Dental drill bit extension FDA UDI
- Model / Reference
- DGDE FDA UDI
Identifiers
- Catalog Number
- DGDE FDA UDI
- Primary DI / UDI-DI
- 10841307119111 FDA UDI
- 510(k) Number
- K081396 FDA UDI
- FDA Product Code
- DZI FDA UDI
- GMDN Term
- Dental drill bit extension FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 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
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 drill bit extension
DirectGuide™ Drill Extender by Implant Direct Sybron Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental drill bit extension.
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Cleared under the same submission
K081396 also covers:
- 5.0mmD RePlant Dense Bone Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- 6.0mmD RePlant Dense Bone Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Cortical Bone Drill for 4.2mmD Implant — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Cortical Bone Drill for 5.7mmD Implant — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- RePlant Soft Bone Step Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- RePlant® Straight Abutment — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- RePlant® Straight Contoured Abutment — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Replant Soft Bone Step Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Replant Soft Bone Step Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Replant Soft Bone Step Drill — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Replant Soft Bone Step Drill Short — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Step Drill (6-16mml) — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Implant Direct Sybron Manufacturing Llc
Sources (1)
- FDA UDI 86e4a6f1-1378-4ad2-8e17-47ef68d6a80b 35 fields · synced May 30, 2026