Identity
- Trade Name
- osseolink Implant FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- Variable Torque Wrench FDA UDI
- Model / Reference
- ITWISO FDA UDI
- Description
- Variable Torque Wrench FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816273020689 FDA UDI
- 510(k) Number
- K091878 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental torque wrench 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
Radiation Sterilization FDA UDI
MR Safe FDA UDI
Category: Dental torque wrench
osseolink Implant by Osseolink Usa Llc — Class II — 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
Cleared under the same submission
K091878 also covers:
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA 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
- Osseolink Usa Llc
Sources (1)
- FDA UDI e95b68c3-a78f-4c78-ae26-1d9ffced02a1 36 fields · synced Jun 8, 2026