Identity
- Trade Name
- CompuDent STA FDA UDI
- Generic Name
- Dental computer assisted anaesthesia injection unit FDA UDI
- Device Name
- STA Instrument FDA UDI
- Model / Reference
- STA-5110 FDA UDI
- Description
- STA Instrument FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20618874000015 FDA UDI
- 510(k) Number
- K061904 FDA UDI
- FDA Product Code
- EJI FDA UDI
- GMDN Term
- Dental computer assisted anaesthesia injection unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6770 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental computer assisted anaesthesia injection unit
CompuDent STA by Tricor Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental computer assisted anaesthesia injection unit.
- CALAJECT — Rønvig Dental Manufacturing A/S · Class II
- SleeperOne 5 — DENTALHITEC · Class II
- CompuDent STA — TRICOR SYSTEMS · Class II
Cleared under the same submission
K061904 also covers:
- CompuDent STA Drive Unit — MILESTONE SCIENTIFIC, INC.
- CompuDent-STA™ Drive Unit — MILESTONE SCIENTIFIC, INC.
- the Wand STA Handpiece — MILESTONE SCIENTIFIC, INC.
- the Wand STA Handpiece — MILESTONE SCIENTIFIC, INC.
- the Wand STA Handpiece — MILESTONE SCIENTIFIC, INC.
- the Wand STA Handpiece — MILESTONE SCIENTIFIC, INC.
- the Wand STA Handpiece — MILESTONE SCIENTIFIC, INC.
- the Wand STA Handpiece — MILESTONE SCIENTIFIC, INC.
- the Wand STA Handpiece — MILESTONE SCIENTIFIC, INC.
- the Wand STA Handpiece — MILESTONE SCIENTIFIC, INC.
- CompuDent STA — TRICOR SYSTEMS
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 |
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Manufacturer
- Manufacturer
- Tricor Systems
Sources (1)
- FDA UDI ebec6c7b-1fad-4d9c-8ea1-2e49d3b3e22f 34 fields · synced Jun 6, 2026