Identity
- Trade Name
- Triton FDA UDI
- Generic Name
- Dental delivery system instrument unit, electric FDA UDI
- Device Name
- Triton Assistant’s System FDA UDI
- Model / Reference
- 90-1046 FDA UDI
- Description
- Triton Assistant’s System FDA UDI
Identifiers
- Catalog Number
- 90-1046 FDA UDI
- Primary DI / UDI-DI
- 00850309007060 FDA UDI
- 510(k) Number
- K110481 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Dental delivery system instrument unit, electric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental delivery system instrument unit, electric
A comprehensive dental delivery system instrument unit, electric designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted.
Similar devices
Also classified as Dental delivery system instrument unit, electric.
- A-dec — A-Dec, Inc. · Class I
- DCI Edge — DCI International, LLC · Class I
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · Class I
- Posterior CleanFlow Procedure Instrument with Matrices — SONENDO, INC. · Class II
- SCALEX — Dentamerica · Class II
- DCI Edge — DCI International, LLC · Class I
- SCALEX — Dentamerica · Class II
- Dentacenter Operative Dental Unit — Safari Dentaire Inc · Class I
Cleared under the same submission
K110481 also covers:
- Advanced Dental/ Endodontics Systems - Umbilical Cart — ASI MEDICAL, INC.
- Advanced Dental/ Endodontics Systems - Umbilical Cart — ASI MEDICAL, INC.
- Extended Worktop - Self-Contained Carts — ASI MEDICAL, INC.
- Extended Worktop - Self-Contained Carts — ASI MEDICAL, INC.
- Extended Worktop - Self-Contained Carts — ASI MEDICAL, INC.
- Extended Worktop - Umbilical Carts — ASI MEDICAL, INC.
- Extended Worktop - Umbilical Carts — ASI MEDICAL, INC.
- Extended Worktop - Umbilical Carts — ASI MEDICAL, INC.
- Extended Worktop - Umbilical Carts — ASI MEDICAL, INC.
- Standard Triton Self-Contained Delivery Systems — ASI MEDICAL, INC.
- Trident Dental System - Extended Worktop — ASI MEDICAL, INC.
- Trident Dental System - Extended Worktop — ASI MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Asi Medical, Inc.
Sources (1)
- FDA UDI b7dd008c-7298-4d38-9743-e49c4bc44552 36 fields · synced Jul 11, 2026