Identity
- Trade Name
- TRIOS FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Model / Reference
- TST-11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05902729753753 FDA UDI
- 510(k) Number
- K221249 FDA UDI
- FDA Product Code
- NBL FDA UDI
- GMDN Term
- Intraoral optical scanning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1745 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
Moist Heat or Steam Sterilization FDA UDI
Category: Intraoral optical scanning system
Trios by 3shape Trios A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraoral optical scanning system.
- Primescan 2 — Sirona Dental Systems GmbH · Class II
- Primescan 2 Multiuse Sleeve — Sirona Dental Systems GmbH · Class II
- COMFORT+ — D.D.S., Inc. · Class II
- PANDA SCANNER — Ziyang Freqty Medical Equipment Co., Ltd. · Class II
- INTELLISCAN 3D® Intraoral Scanner — Shining 3D Tech Co., Ltd. · Class II
- SHINING 3D® Intraoral Scanner — Shining 3D Tech Co., Ltd. · Class II
- Ori — ORI INC · Class II
- R2i3 — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K221249 also covers:
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
- 3shape Trios A/S
Sources (1)
- FDA UDI 5ff2e5e2-53ca-40fb-9fcc-8fbb25602fa4 34 fields · synced May 30, 2026