Identity
- Trade Name
- Dongle for Scanner FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, laboratory FDA UDI
- Device Name
- Dongle for Scanner FDA UDI
- Model / Reference
- KTAP0380 FDA UDI
- Description
- Dongle for Scanner FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800KTAP0380 FDA UDI
- FDA Product Code
- NOF FDA UDI
- GMDN Term
- Dental milling system, CAD/CAM, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3661 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental milling system, CAD/CAM, laboratory
Dongle for Scanner by Zirkonzahn GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental milling system, CAD/CAM, laboratory.
- KLOCKNER — SOADCO, S.L. · Class I
- AccuPlan System — Medcad · Class II
- 3Shape Scan Bodies — 3shape Trios A/S · Class I
- KLOCKNER — SOADCO, S.L. · Class I
- KLOCKNER — SOADCO, S.L. · Class I
- KLOCKNER — SOADCO, S.L. · Class I
- KLOCKNER — SOADCO, S.L. · Class I
- 3Shape Scan Bodies — 3shape Trios A/S · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zirkonzahn GmbH
Sources (1)
- FDA UDI 1c71c8ce-ba9b-4b82-9d26-33ee5e51feac 33 fields · synced May 30, 2026