Identity
- Trade Name
- Digital Orthodontic Care FDA UDI
- Generic Name
- Orthodontic appliance positioning tray FDA UDI
- Model / Reference
- DOCWT FDA UDI
Identifiers
- Primary DI / UDI-DI
- D918DOCWT0 FDA UDI
- FDA Product Code
- QJJ FDA UDI
- GMDN Term
- Orthodontic appliance positioning tray FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Category: Orthodontic appliance positioning tray
Digital Orthodontic Care by Digital Orthodontic Care — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic appliance positioning tray.
- FotoDent® IBT 385 nm — Dreve Dentamid GmbH · Class I
- Celebrace — Celebrace · Class I
- SureSmile® — ORAMETRIX, INC. · Class I
- 3M™ — 3M COMPANY · 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
- Digital Orthodontic Care
Sources (1)
- FDA UDI 7a1ab4d0-4a0d-4653-9702-e6f80e46b1c2 32 fields · synced Jun 7, 2026