Identity
- Trade Name
- XiVE® FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- Surgical Ratchet with Torque Indication FDA UDI
- Model / Reference
- 45-6010 FDA UDI
- Description
- Surgical Ratchet with Torque Indication FDA UDI
Identifiers
- Catalog Number
- 45-6010 FDA UDI
- Primary DI / UDI-DI
- 07392532230011 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental torque wrench 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
No
FDA UDI
Category: Dental torque wrench
XiVE® by Dentsply Implants Manufacturing GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental torque wrench.
- Torque Wrench Kit — Elos Medtech Pinol A/S · Class I
- Torque Wrench — Elos Medtech Pinol A/S · Class I
- Restore — Keystone Dental Inc. · Class I
- 4-Part Telescoping Herbst Replacement Parts — SPECIALTY APPLIANCES, LLC · Class I
- RS 2.45 Hex Handpiece Adapter FLX - Short — ADIN DENTAL IMPLANT SYSTEMS LTD · Class I
- Azure — TERRATS MEDICAL SL. · Class I
- Graduated Torque Wrench — Sterngold Dental LLC · Class I
- SURGICAL TORQUE RATCHET — S.I.N. - Sistema DE Implante Nacional S.A. · 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
- Dentsply Implants Manufacturing GmbH
Sources (1)
- FDA UDI cb5de5da-28f4-4eca-8af1-8e98c498b8db 34 fields · synced May 30, 2026