Identity
- Trade Name
- AVALON BIOMED FDA UDI
- Generic Name
- Sonic endodontic broach FDA UDI
- Model / Reference
- BlueShaper sterile files 25mm Z1 (6 units) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975718059340 FDA UDI
- FDA Product Code
- EKS FDA UDI
- GMDN Term
- Sonic endodontic broach FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sonic endodontic broach
Avalon Biomed by Shenzhen Denco Medical Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sonic endodontic broach.
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- SCOTT'S SELECT BARBED BROACHES 10/pk 21mm # XF — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
- SCOTT'S SELECT BARBED BROACHES 10/pk 21mm # ASST — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
- SCOTT'S SELECT BARBED BROACHES 10/pk 21mm # XXXXF — SCOTT'S DENTAL SUPPLY L.L.C. · 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
- Shenzhen Denco Medical Co., Ltd
Sources (1)
- FDA UDI 53d50bc2-4bd6-430a-ab5c-4d756de9edd3 33 fields · synced May 30, 2026