Identity
- Trade Name
- Denco FDA UDI
- Generic Name
- Manual endodontic filling material spreader FDA UDI
- Model / Reference
- Gutta Percha Pluggers #60-#120 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975718055380 FDA UDI
- FDA Product Code
- EKK FDA UDI
- GMDN Term
- Manual endodontic filling material spreader FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Denco by Shenzhen Denco Medical Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Shenzhen Denco Medical Co., Ltd
Sources (1)
- FDA UDI 4e063622-3730-4c7d-a2dd-2347a45268cf 33 fields · synced May 30, 2026