Identity
- Trade Name
- ZILMASTER FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- ZILMASTER COARSE HP MINI PT 3P FDA UDI
- Model / Reference
- 0641 FDA UDI
- Description
- ZILMASTER COARSE HP MINI PT 3P FDA UDI
Identifiers
- Catalog Number
- 0641 FDA UDI
- Primary DI / UDI-DI
- E23506410 FDA UDI
- FDA Product Code
- EHL FDA UDI
- GMDN Term
- Dental abrasive point, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6010 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
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental abrasive point, reusable
Zilmaster by Shofu Dental Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental abrasive point, reusable.
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- EDENTA — EDENTA ETABLISSEMENT · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- Alpen — Coltene/Whaledent Inc. · Class I
- Strauss Diamond — Diamond Strauss Instruments Inc · 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
- Shofu Dental Corp.
Sources (1)
- FDA UDI a6814f5d-7e2c-4a59-a587-73e141893eca 35 fields · synced Jun 6, 2026