Identity
- Trade Name
- iSmile FDA UDI
- Generic Name
- Dental cotton roll FDA UDI
- Device Name
- Cotton Roll Non-Sterile Medium 1-1/2" length FDA UDI
- Model / Reference
- 25-0001 FDA UDI
- Description
- Cotton Roll Non-Sterile Medium 1-1/2" length FDA UDI
Identifiers
- Catalog Number
- 25-0001 FDA UDI
- Primary DI / UDI-DI
- 00816419021501 FDA UDI
- FDA Product Code
- EFN FDA UDI
- GMDN Term
- Dental cotton roll FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6050 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: Dental cotton roll
iSmile by Ismile Dental Products Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental cotton roll.
- PureLife+ Cotton Rolls — PURELIFE, LLC · Class I
- Monoart — EURONDA SPA · Class I
- Monoart — EURONDA SPA · Class I
- PureLife+ Cotton Tip Applicators — PURELIFE, LLC · Class I
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- JMU — JMU DENTAL, INC · Class I
- Mirror Cotton Holders — PRACTICON, INC. · Class I
- Monoart — EURONDA SPA · 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
- Ismile Dental Products Inc.
Sources (1)
- FDA UDI be6d1f4b-c122-4139-9149-525358034147 35 fields · synced May 31, 2026