Identity
- Trade Name
- Iris FDA UDI
- Generic Name
- Intraoral camera FDA UDI
- Device Name
- IRIS X90 Intraoral Camera FDA UDI
- Model / Reference
- X90 FDA UDI
- Description
- IRIS X90 Intraoral Camera FDA UDI
Identifiers
- Catalog Number
- IRIS-X90 FDA UDI
- Primary DI / UDI-DI
- 00813557020205 FDA UDI
- 510(k) Number
- K981663 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Intraoral camera 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
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Category: Intraoral camera
Iris by Digital Doc LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraoral camera.
- EzCam — Dentall Corporation · Class I
- A-dec — A-Dec, Inc. · Class II
- IOC-Holder — Dentall Corporation · Class I
- Osstem Implant Co., Ltd. — OSSTEM IMPLANT Co., Ltd. · Class II
- Opti plus HD — Dentall Corporation · Class I
- LED IC100 — Dentall Corporation · Class I
- APOZA — APOZA ENTERPRISE CO., LTD. · Class I
- AIOBIO — AIOBIO Co., Ltd. · Class I
Cleared under the same submission
K981663 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Digital Doc LLC
Sources (1)
- FDA UDI b3746318-7cfe-4074-8b69-5a9c98d45a7a 35 fields · synced May 31, 2026