Identity
- Trade Name
- Plasdent FDA UDI
- Generic Name
- Dental cotton roll FDA UDI
- Device Name
- Cotton Rolls, EO Gas Sterile, #2 FDA UDI
- Model / Reference
- CTR-S540 FDA UDI
- Description
- Cotton Rolls, EO Gas Sterile, #2 FDA UDI
Identifiers
- Catalog Number
- CTR-S540 FDA UDI
- Primary DI / UDI-DI
- D832CTRS5401 FDA UDI
- FDA Product Code
- NAB FDA UDI
- GMDN Term
- Dental cotton roll FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental cotton roll
Plasdent by Plasdent Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental cotton roll.
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- 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 |
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Manufacturer
- Manufacturer
- Plasdent Corp.
Sources (1)
- FDA UDI 21e76056-f70e-4d3b-8244-b88f60cc1166 34 fields · synced May 30, 2026