Identity
- Trade Name
- MEDENTiKA FDA UDI
- Generic Name
- Dental torque wrench adaptor FDA UDI
- Device Name
- ISO shank adapter FDA UDI
- Model / Reference
- M 14 FDA UDI
- Description
- ISO shank adapter FDA UDI
Identifiers
- Catalog Number
- M 14 FDA UDI
- Primary DI / UDI-DI
- 04251574822833 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental torque wrench adaptor 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental torque wrench adaptor
MEDENTiKA by Medentika GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental torque wrench adaptor.
- Torque Ratchet — DENTIS CO. , LTD · Class I
- Preat — PREAT Corporation · Class I
- Implant-One — Implant Logistics, Inc. · Class I
- Zeramex(R) Ratchet Adaptor Unit Short — Josef Ganter Feinmechanik GmbH · Class I
- Wrench adapter — DENTIS CO. , LTD · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medentika GmbH
Sources (1)
- FDA UDI 4c129c7b-d86b-41e4-b91b-4c3766110393 35 fields · synced Jun 6, 2026